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OasisLIMS 4.0 Enterprise

AN ENTERPRISE SOLUTION FOR LARGE SIZE LABORATORIES AND R&D CENTERS …

A trusted product in the market, many large laboratories run their entire operations on OasisLIMS efficiently by automating core lab processes through instruments integration and other quality management systems. OasisLIMS is pre-validated out-of-the-box solution with web based capabilities and advanced configurability that reduces implementation time and cost with minimum resource allocation that Pharma organization can leverage on proven technology to comply with GAMP guidelines, and implement standard industrial practices across enterprise.

Why OasisLIMS ?

  • Fast track implementation methods with minimum resource requirements
  • Fully compliant with many regulatory guidelines
  • Reliable and constant support from last many years
  • Domain inheritance, industry experi¬ence and technical expertise

Pharmaceutical-Specific Functionality
A 100% web-based, enterprise LIMS, supports GxP requirements and offers comprehensive functionality to facilitate compliance with standards such as 21 CFR Part 11, MHRA, GAMP and ISO17025 and the system is designed and developed, tested and maintained using software quality standards

KEY FEATURES

The solution includes the following functionality to support pharma
  • Specifications Management and Review
  • Full sample life cycle management to monitor and control raw materials, in-process and finished products quality
  • End-to-end sample workflow with reporting and charting
  • Lot and batch management
  • Stability testing and inventory management
  • Dashboards / Alerts - Reminders
  • Staged Labels printing
  • Automated on-line test method calculations and specification checking
  • Work review routing and sign off
  • Consumables inventory tracking including reagents and standards
  • Instrument calibration, certification and maintenance
  • Scheduling of water and environmental monitoring samples
  • Tracking analyst training, certification and qualification

Compliance and Regulations
A wide variety of standard functionality is available under OasisLIMS to help meet regulatory and security requirements, that includes ...

  • Full control of data review and approval
  • Ideal Sessions Timeouts
  • Password checks
  • Extensive versioning capabilities

Electronic signatures and Electronic Records
  • Ability to configure secure electronic signatures for any system operation
  • Provides complete audit-trail functions to ensure data accuracy which in turn leads to better regulatory compliance.

OasisLIMS features and functions at a glance …

Masters Management and Control

Efficient management of Master Definitions
All Master Information
Materials, Products, Vendors, Customers, Units, Specifications and Various Miscellaneous
Management and Control
Control over masters with referencial integrity ensures constancy of output
Track Masters
Oasis allows to track key master records and their respective attributes, values with revisions

Sample Lifecycle and Execution

Manage samples through their entire lifespan with end-to-end traceability.

Sample login / Receipt
Sample registration enables users to register a single sample, the registration process allows the user to identify a sample with unique number and automatically assign tests from product-specification through the process of sampling. It is possible for samples to be logged into OasisLIMS by users that are not physically located within the laboratory or automatically via automatic schedule or ERP interface.

Batch Management
Within manufacturing facilities the production is normally based on a batch and accordingly samples of raw, intermediate and finished are managed for batch approvals. Whereas in research or analytical services laboratories the samples may be associated based on a specific work Request, Job or Submission.

Work Allocation
OasisLIMS may be configured to automatically assign tests to lab groups or individual analysts. Tests that are automatically assigned may be easily re-assigned to other analysts by authorized users using a simple interface.

Workflow Based Guided Sample Execution

Sequence of steps
Sample execution cycle is workflow based; users are guided step-by-step by the system through the tasks configured in the system.

Sample Tracking
Sample tracking system helps users to quickly view sample status.

Labels with Barcode Generation

Print labels with formatted barcodes
Generated at different stages of sample-life-cycle such as under test, sampled, approved, rejected etc. Provision to track inventory of different types labels printed through system.

Worksheet Generation
A wide variety of worksheets are available which may be used to help the laboratory efficiently process samples, worksheets may be organized by lab departments, by individual or any other logical criteria. The worksheet may be presented on the screen, printed to hardcopy and passed to an analyst to record observations.

Results Entry / Analytical Quality Control
OasisLIMS provides a mode of results entry whereby the user may select a single sample using one or more of its descriptive identifiers. When the sample is selected a listing of all of the required results will be presented for entry, system has built in test method calculations to obtain result. Built-in validation procedures monitor the accuracy of analytical methods and results

Results Validation / Review & Approval
In many laboratories it is a standard operating procedure to require results that were entered into OasisLIMS to be reviewed by a senior manager. This is often the case within pharmaceutical or any other regulated laboratory. When this level of data review is not required, or if data is only reviewed when it does not meet its specification requirements, the results validation step may be bypassed. The sample approval step is used to confirm that the sample's testing cycle has ended and the laboratory management has given the sample a final disposition. The dispositioning of samples will differ from lab to lab; however, most laboratories assign disposition status' which include Approved, Rejected, OOS etc. This lets the rest of the organization know what was determined by virtue of the laboratory's testing of the sample.

Samples Management Module

Manage various types of samples process execution using a variety of workflow features with enforcement of laboratory process to ensure compliance as per standard operating procedures (SOP) and lab methods. Increase throughput while reducing calculations and transcription of errors.

Sample Management
Manage samples through their entire life Cycle in the system with end-to-end tractability.
Batch Management
Product batch wise samples analysis and testing of raw material, in-process, finished products.
Analytical Methods
Analysis with accuracy using built-in validated test methods through automatic on line calculations, eliminates mistakes and transcription errors.
Workflow Execution
System guides the user execution of tasks in a sequence of steps as per workflow configured in processing of various types of samples in lab
Inventory Management
Inventory management of standards, solutions, reagents, and other items in the laboratory for processing of samples
Consumables Management
Management of lab consumables life cycle from items preparation/receipt to their consumptions and distructions
Automatic Schedulers
Schedule repeated samples registration on a frequency such as stability, environment / water and other tasks or events such as reporting, notifications
Review Management
Reviews and approvals of testing and releasing of submitted samples for disposals.
Lab Monitoring
Monitoring of laboratory samples across various locations and surfaces with compete visibility of status of processing stage of execution
Stability Management
Manage realtime and shelf-life analysis of stability samples of intervals at intervals placed under various experiment conditions with tracking of study samples inventories.
Instrument Management
Management of instruments used in laboratory for analyzing samples in lab, allows tracking of usage, maintenance and calibration of instruments and their components.
Electronic Worksheets
Dynamic electronic worksheets replace the need for maintaining manual laboratory note books, eliminates unnecessary paper records. It has ability to record test readings, experiments and collaborate lab resources utilized in execution of samples.
Ad-hoc Query
Generation of a data queries using search filters on many attributes and export data in excel format
Reports Designer
Built-in designer tool to design layout of Certificate of Analysis, Worksheets and Specification reports independently.
Barcode Integration
Labels and other reports can have barcodes incorporated to read and search key information efficiently

Authorizations with e-Signatures
Provision for electronic signature under ‘n’ levels of authorization in a chain of approvals i.e. Prepared by / Checked by / Reviewed by and Approved by. System users have authorization levels assigned depending upon their role and responsibility. Rejection at any stage with the provision for incorporation of remarks – under back tracking process for resubmission of Record

OOS (Out of Specification)
If the sample does not meeting specification limits while CoA generation; immediately OOS procedure is triggered and investigation process takes place in a workflow manner as per standard practices of user company to identify the root cause and failures, the investigation templates / checklists are user defined and decision for re-analysis of sample by analyst are taken, there is facility to generate complete activities of OOS sample logs and non-conformance reports. OOS module is interfaced with Oasis-QMS to Identify, investigate and report incidents occurring through laboratory operations followed by corrective and preventive action procedure to avoid reoccurrence of incident.

OOT (Out of Trend)
OasisLIMS keeps track of historical trends of the results captured in past of individual test parameter pertaining to a product, these are compared with the tolerance limits, on the event of any deviation from benchmark values / reference values the system alerts generated and investigation of OOT can take place to identify the root cause under this situation. OOT module is interfaced with Oasis-QMS to Identify, investigate and report incidents occurring through laboratory operations followed by corrective and preventive action procedure to avoid reoccurrence of incident.

Audit and Activity History
View all activities related to sample processing and execution that have occurred in a workflow.

Automatic Scheduler
Scheduler permits users to specify automatic sample logins, reports and work at time intervals through a simple table entry, samples will be automatically be logged into OasisLIMS at the specified time and given the status of new sample logged, but not received in the laboratory.

ELN, Electronic Lab Notebook
OasisLIMS ELN (Electronic Note Books) enables you to record information in electronic form that is associated with sample data and ensures that it is accurately recorded, this includes Instruments, personal, standards, chemicals/reagents, volumetric solutions and procedures, most importantly automatic on-line test method calculations with details of raw data and formula used. There is no need to maintain paper based worksheets if this feature is enabled.

Corrective Action and Preventive Action
Identify, investigate and report incidents occurring through laboratory operations

Lab Service Level Reports and Quick Data Retrieval

Reporting
On-demand reporting and data visualization using industry standard tools. Yes, OasisLIMS powerful and flexible industry standard reporting tool that has ability to produce several reports to conform to any regulatory requirements, management information and graphical reports Data set stored in OasisLIMS database is accessible and can be displayed or printed in a wide variety of reports, most of the report have filters applied that enables point-and-click query construction to generate instant report layouts. A standard set of report is available on various categories to support MIS and lab service level reports and reports for regulatory compliance.

Dashboards
With OasisLIMS dashboard capabilities you can have vital information at your finger tips, view all your key performance indicators (KPI’s) at a glance to make informed decision. It provides the real time graphical displays in a grid, giving you the required information to act upon. Ad-hoc Query:- Define a data query using search filters and export data.

User Defined Reports and Templates
Yes, OasisLIMS provides a configurable user defined reporting system to design basic elements of report such as header, footer and details. It helps users design configurable CoA for various types of samples such as raw, packing, intermediate, finished, water, stability, calibration etc. Configurable worksheets allow you to design layout and format of various types of worksheet to be generated dynamically. Provision for designing of labels at user's end for various types of labels Search Engine on Views and Update lists Built-in powerful search engine to look for data across the system on descriptive parameters such as batch, sample id, product etc

Data Files linking
OasisLIMS provides links between database records and external files as attachments, the contents of the externally linked file can be displayed simply by clicking on the link and down loading the file. Options are available to set up external files storage, to a central location on server in a shared folder, also into the database itself, where it can be accessed by all OasisLIMS users in a secured manner.

Provides several reporting and screen options for getting data out of the system with meaningful filters

Reporting
On-demand reporting and data visualization using industry standard tools.
Dashboards
View all your key performance indicators (KPIs) at a glance.
Search Engine
Built-in search engine to look for data element across the system.
Ad-hoc Query
User defined generation of a data queries using search filters on many attributes and export data in excel format
Reports Designer
Built-in designer tool to design layout of Certificate of Analysis, Worksheets and Specification reports independently.
Barcode Integration
Labels and other reports can have barcodes incorporated to read and search key information efficiently

Security and Auditing

Oasis provides security and auditing options to ensure data safety and compliance with regulations.

Data security
Restrict access to data based on role, department or object –level permissions.

Auditing
Store and view changes made to records. Provision to maintain audit logs with reason for change or deletion of information be it Master data or Transactional data. Process of recording what changes were made, who made the changes, when the changes were made and why the changes were made. The changes could be in the Profile Settings or items registered under Master data and Transactional data.

Audit trails Report
User defined filters are available on report to generate it between dates, on user, on activity, or the type of operation Audit logs also show old value and the new value together on the event of change.

Regulatory Compliances
Compliant with US FDA 21 CFR Part 11, Euro Annex 11, PIC/S guide lines OasisLIMS is designed to meet regulatory compliance with stringent requirements of various regulations on electronic records and electronic signatures

Single sign-on
Enable single sign-on using LDAP or other SSO implementations. Electronic Signatures and Electronic Records Every electronic record has time stamp linked to it with user id’s 21 CFR Part 11/Annex 11 requirements for electronic records and signatures supported. The purpose of Oasis LIMS Electronic Signature is to authenticate specified actions (created by, checked by, reviewed by, approved by) executed by the users with electronic signatures. The actions like master data registrations or changes, test result submissions and approvals etc. may be configured to demand authentication. The authentication is executed by the user with his / her user name and password. The Electronic signature will bear the date and time stamp. It will represent the action so authenticated.

Authentic date
System picks up server date and time.

Security and Auditing

Security
System functions are restricted through role based access to the data by users with permissions for authenticity of data.
Electronic Records and Signatures
Guidelines of 21 CFR Part 11 / EU Annex 11 details the requirements for electronic records and signatures supported systems
Audit Trails
Comprehensive audit logs that captures who, did, what, when and why? Audit trails stores information of all the activities, changes and deletion that happen in the system data in real time manner.


System Interfaces and Instruments Integration

Instrument Integration
Interface with most networkable instruments. Instrument integration through O-Link instrument integrator, a high level integration can be achieved using O-Link that communications directly with the instruments that ensures acquisition / capturing of data from various equipments, O-Link connects with instruments through RS 232 port (serial communication port) / TCP-IP / File based output, direct database access from CDS desktop /server for capturing results. Intermediate results captured from CDS can be used for further in the calculation to obtain final results through user defined test methods developments.

SAP Integration
SAP certified OasisLIMS bi-directional data transfer integration process. OasisLIMS/SAP integration provides customized solution to communicate data between OasisLIMS and your company's SAP software system. OasisLIMS/SAP interface permits samples to be automatically logged into OasisLIMS from SAP and permits OasisLIMS to communicate sample and test status back to the SAP. These communications may occur either on an event or timed basis depending upon implementation requirements Three levels of interface is available, text / CSV file, BAPI RFC and web service oriented through XI/PI, each interface differs from installation to installation and because of this, the SAP interface is a customized function of OasisLIMS integration architecture.

3rd Party Application Integration
ERP (SAP, Navision, Oracle, JDE etc.), PIMS (Aspen Tech IP 21, OPC Server), SQC

System Interfaces

Oasis enables interfacing with instruments and systems to increase automation and reduce data entry errors.

Instrument Integration
Using O-Link server to interface with instruments that are on network having standard ports and compatibility to communicate date.
SAP Integration
3 levels of bi-directional interface to transfer between SAP and the system; integration developed by Oasis has been certified by SAP labs.
3rd Party Tools Integration
Integration with SQC (Statistical Quality Control), QMS (quality Management System), Tally Accounting etc. through a seamless interface.

Integrated Validationed Support


OasisLIMS offers an integrated implementation approach with a well-defined validation plan and execution methods based on GAMP guidelines. OasisLIMS comes as a solution that provides fully documented validation procedures of the product deliverables that is designed by the professional validation specialists having expertise and deep understanding of regulatory require¬ments also to help companies meet compliances operating in regulated industries. OasisLIMS support services include validation planning, test script development and provide assistance in execution;

  • Well defined Validation Master Plan
  • User Requirements that cover common industry processes and needs
  • Comprehensive Functional Specification of the standard features and functions available
  • Protocols (IQ/OQ/PQ) and verified test scripts in line with the product workflow and functions
  • A set of users manual and standard operating procedures including system security, deviations and change control management forms
  • Finally Traceability Matrix, Validation Report with Validation Summary and System Release Documents

Configuration and Framework

In-Built Configuration tools
Configure and extend user interface, data profiling and business logic without programming.

Multi-Plant Operations
OasisLIMS Multi-Site Architacture supports single OasisLIMS implementation to restrict access to information and functions to individual laboratory groups site-specific. This is especially useful when operating multiple plants within a single database runing over a Wide Area Network (WAN).

Email - Interal / external
Interal Oasis mail system for the LIMS users to exchange messages amongt themselves, with standard functionality e.g. compose, broadcast, multicast, attach etc. External email configuration through SMTP allows automatic generation of mails for customer specific actions / reports such as, Test reports, COA's, OOS, event based notifications, schedules and reports.

Integrated SMS Mobile gateway
Falsh users with instantaneous messaging / notifications through SMS on mobile on critical events / advance notes

Backup and restore/recovery
Built-in back-up and restore facility with different modes Scheduled, unscheduled and on any medium / folder-dirrectory / Device

Notifications
Upon log on or otherwise, automatic alerts / reminders trigger for samples due for retest, equipment due for calibration, samples for destruction, samples for sampling / analysis / review / work assignment working / reference standards due for standardization, samples pending for stability analysis etc. Easier Implementation and Management

Data import
Import and process data from different file formats (CSV, delimited, XML and Excel) for generation of masters in initial set-up.

Export reports
Enhanced feature under newly upgraded report generator, On-line export in various industry standard formats such as Excel, PDF, HTML, RTF, TEXT etc.

Electronic Worksheets through eForms (Optional Module)
Enter reading / observations data directly in standard templates for various analytical methods that looks and feels like working on a paper based input form.

Web services to Interface
Industry standard XML/SOAP/JSON based web services enable easy integration for communication of data with other systems on enterprise network.

New User Interface, an improvised user experience
An excellent easy-to-use interface that improvises user experience with enhancements in navigating system items through various methods of access

Home Screen Panels with Advanced Look and Feel
Easy access codes for quick navigation and drill downs for view and updates, panels for fast shortcuts and smart navigations to screens, reports, notifications, alerts, reminders, recently accesses items, quick links results in saving time. Home screen, after initial logon process, clear start-up process

Enhanced Operational Ability
Ease of navigation and quick searches on user choice parameters allow faster retrieval if information being sought that increases productivity and efficiency.

On-Line Context sensitive help
Indexed TOC (Table of Contents) / exhaustive / detailed help is available in electronic form with hyper links that offers execllent user experience with search and easy navigation capabilities.

OasisLIMS Professional

AN IDEAL SOLUTION FOR SMALL AND MID SIZE LABORATORIES…

Operating under pharma, chemicals, petro, textiles, oil/gas ... domain

OasisLIMS Professional is a comprehensive web based and client / Server based standard laboratory information management software, it is suitable small and mid size laboratories for a wide range of laboratory applications. OasisLIMS Professional’s native functionality allows you to effectively manage the flow of samples and associated data to improve lab efficiency; it helps standardize workflows, tests and procedures, while providing accurate controls of the process. Automatic on-line calculations are integrated into the LIMS to record collection of test data and eliminate error, lab resource allocation module ensures that instruments used in analysis are properly calibrated and operated by trained/qualified staff only. It also ensures chemicals; standards and reagents used in performing analysis are suitable for their intended use.



OasisLIMS key functions include revision controls of masters incline organizations to use a LIMS and ‘go paperless’ to meet best practice or compliance requirements, for pharma or other regulatory major organizations OasisLIMS professional may also be configured to incorporate audit trails to capture changes to results, test procedures, instruments and chemicals used during analysis. Implementing OasisLIMS professional saves valuable man-hours of technical staff, saves time spent in writing and checking in individual reports. The time saved – utilized for other important / productive tasks in the lab. The main purpose of a OasisLIMS is to improve lab efficiency and accuracy by reducing manual operations, it will performs a range of core functions that includes


Sample Management / Sampling / Worksheets / Workflow management / Test data record keeping / Automatic test method calculations / Inventory management / Instruments management / Reporting / Administration and control / Flexible Reporting / Trending and Analytical Quality Control / Standard Operating Procedures Maintenance / Instruments Management / Inventory Management / Auditing and Security / Simple User Interface

Master Specification Maintenance;

  • • Specifications for raw materials / packing materials / intermediates / bulk / finished products / Water / Standards / Solutions easily maintained, with the facility of revisions history
  • • No need to refer to specifications repeatedly at the time of analysis

Sample Management;

Sample management and laboratory workflow is predominant in day-to-day laboratory operations; OasisLIMS provides support for a wide range of functions within the laboratory to efficiently manage samples searching and display, sample registration, tracking and auditing, test maintenance and Test result entry, Result review, release and approval, Certification and reporting etc.

Sample Login;

  • • On GRN / production intimation, sample login takes place in the software with minimum parameters
  • • Allows many types of logins such as normal sample, retest, pre-shipment/ pre-purchase, reanalysis, market, control etc.
  • • Automatic, unique Sample ID or Analytical report No generation for different categories of samples
  • • Facility to enter sampling plan for every product/material
  • • Sampling details and sampling observation entry
  • • Option of partial/reduced analysis
  • • Tests automatically allocated to the sample
  • • Option for adding new tests, changing limits after sample registration

Worksheets and Labels;

OasisLIMS allows you to present sample and test data as a collection of worksheets in a workbook format with the number sequence. Any user with the appropriate privileges can edit all the layout styles/formats for each test, without the need for any programming.

  • • User defined worksheet layout/format for entry of readings / observations, as per drugs and cosmetic act and the rules or as per in-house testing procedures
  • • Automatic generation of worksheets dynamically, for raw materials / packing materials / intermediates / bulk / finished products, indicating all the tests to be performed as per standard / in-house specifications).
  • • Work sheet may also incorporate method of analysis, optionally.
  • • Labels at different stages of sample progression can be generated, under test, sampled, approved/rejected etc.

Result entry and Test Methods/Calculations (User Defined through Excel Interface);

On the basis of work allocation, result entry, test wise or sample ID wise can be entered in a flexible input formats for qualitative, quantitative analysis with description, conform or non-conform, standard pre-configured validated calculations for LOD, Assay, Purity, UOC, Dissolution, GC/HPLC, average weight etc. provision for user defined test method calculations.

  • • It eliminates possibilities of calculation mistakes, saves significant time of chemists, allowing laboratory technicians to do value added work.
  • • No need to maintain manual notebooks for calculations as calculation sheet / raw data sheet automatically generated as detailed CoA, practically there is no need to verify / check results as test method calculations are validated.

Generation of CoA - Certificate of Analysis;

OasisLIMS generates CoA, beside standard format various layouts of CoA may be designed and printed depending upon sample type, Process of CoA generation cross verifies results with the specification limits for decision of approval or rejection of sample and accordingly opinion of disposition status is generated automatically, in case of non-conformance of sample, final report incorporates rejection parameters that means system itself is designed to take decision independently, it eliminates possibility of biased opinion.



Reporting;

OasisLIMS Professional’s powerful and flexible industry standard reporting tool that has ability to produce several reports to conform to any regulatory requirements, management information and graphical reports Data set stored in OasisLIMS database is accessible and can be displayed or printed in a wide variety of reports, most of the report have filters applied that enables point-and-click query construction to generate instant report layouts. A standard set of report is available on various categories to support MIS and lab service level reports and reports for regulatory compliance.

Regulatory;

Specifications, Work Sheet, CoA - Certificate of Analysis, Sampling sheet, Sample register, Rejection register, Labels (under test, approved, rejected, sampled, quarantined etc.)

MIS;

QC productivity, Analyst performance, Samples pending for sampling, Samples pending for analysis, Samples pending for entry of results, COA pending for review, COA pending for printing, Lab performance report on various parameters, Sample approval status, Samples for retest

Sample Scheduling;

OasisLIMS scheduler allows you to create predefined flexible schedules and generates samples registration and sometimes reports automatically. This is general requirement of industry where samples are required to be processed over a period on regular intervals and under manual control there is a chance of omission, with powerful scheduling tool OasisLIMS automatically determines and generates alert / reminder for samples as and when due for processing. Built-in Scheduler uses rules defined using data management tools to program system what it should do and when.

Equipment Calibration and Maintenance;

Equipment management module provides integrated functions that allow users to define and closely monitor equipments that are used for analyzing samples; It also enables users to track calibration due and record calibration results and maintains on-line data for monitoring both usage and performance. Users can schedule and monitor instrument maintenance, and create alerts to be triggered when the time threshold for maintenance expires. System keeps track of instrument history maintenance records.

Inventory Management;

OasisLIMS incorporates a comprehensive stock control and inventory management system, this module covers stock control from receipt to issuance of chemicals, glassware, reagents, solutions used in laboratory for analyzing various types of samples. The inventory and storage management functions of the OasisLIMS allow users to maintain stocks of items and their validity. The system also generates re-order alerts when inventory levels go down from a specific range. The combination of inventory management software with tracking procedure makes it useful tool for any laboratory. Reports are available to track stock receipts and consumption with many other useful details, printing of labels for identification of consumables is also available. User Administration and Security OasisLIMS has been designed to support accredited laboratories those follow establish formal quality procedures that demand the highest system integrity and security of data in the system. OasisLIMS provides foolproof security controls in place to ensure that system administrators have complete control in defining users, passwords, user roles. Administrator grants right to access and privileges to a specific function of system to a an individual depending upon his/her role and responsibility.

Standard Operating/Testing Procedures;

OasisLIMS has built in word processor to maintain SOPs used in various activities in a laboratory as guidelines and reference quality procedures, these SOP’s either be edited directly and stored within OasisLIMS secured database using standard editing functions or can be imported from an external package such as Microsoft Word™. Option is also available to store files as attachments with efficient folder management to properly organize information tagged with unique document ID’s. The attachment is then stored as a BLOB (Binary Large OBject) in the OasisLIMS database for security. SOPs can be versioned to maintain the most up-to-date current version on top and SOP’s can also be aged.

Auditing;

OasisLIMS includes one of the most comprehensive audit trail and trace log functions available, allowing you to maintain an audit log for every entry on the system to check what was changed, when, why and by whom. All modifications are recorded and subsequently stored for future examination and reference.

Easy to Use Interface;

OasisLIMS familiar and easy-to-use interface is vital to maximizing productivity and reducing user training time. New users can become proficient more quickly and occasional users easily retain their facility with this Microsoft Office-like interface. Based on familiar functionality within Microsoft Excel™, OasisLIMS workbook, worksheet, folder and sample architecture allows users to recreate the laboratory's business practices, without the need for any complex IT involvement.

LIMZ-RD

LIMS FOR PHARMACEUTICAL PRODUCT DEVELOPMENT AND R&D ENVIRONMENTS

Specifically desiged for Pharmaceutials, API's and Chemicals development Laboratories

LIMZ-RD has been specifically designed for R&D companies contributing to new drug development programs and engaged in following activities, such as – Formulation Development, API Characterization, Material compatibility studies, Stability studies of APIs and formulations, method validation, Dissolution profiling, Impurity Profiling (customized to suit client requirements).

LIMZ RD is highly flexible, easily configurable system that increases workflow efficiency, throughput and data reliability while simplifying administration, sample traceability and regulatory compliance in any R&D environments.

LIMZ RD has ability to generate comprehensive quality documentation from various integrated modules that support for the submission and maintenance of all required regulatory documentation.

A very useful solution for research organizations for helping Pharma companies seeking support for patent and rendering it ready for commercial manufacturing stages.

LIMZ RD can be suitably customized to automate contract research studies in various areas of AD and FD and is built for compliance with GLP (Good Laboratory Practices) regulations and US FDA 21 CFR Part - 11 guidelines.

Some Salient features…

Project Management & Master Planning

Provision for defining the project initiation and scope of work, timelines, SOPs, protocol and methods requirements. OasisLIMS maintains complete information of the project at different stages; a project passes through several levels of processes during life cycle. Separate option is available that focuses on introductory information and innovator's detail of the project. It holds the information related to project objective, scope, planning and its properties. It also allows you to enter various attributes of project, outlines, overview, sources of information and references
Product / Client / Test master
Defining 'n' number of tests which are performed on a sample Reports: Product / Material master, Client master, Test master
Specifications - Product - test - test method links
Establishing link among product, its tests and the tests methods required to carry out the tests.
Limits
Defining different types of limits, trend values and tolerance for test (s), product wise
Formulations
Archival and Storage Ability to archive and store all previous formulations.
Data Retrieval
Easier to gather data for new product submission or patent.
Enhanced Formulation Management and Search
Speeds up new product development and reduces duplication.

Transaction processing

Sample Management Sample Management modules allow users to effectively handle and manage the received samples efficiently.
Sample registration and login
For various sample types and categories
Batch Sample Registration
Automatic sample registration for Samples received in batches
Sample Bar Code Labels
Bar Codes support for identification and selection of sample
Automatic AR number generation
System assigns unique configurable sequenced numbers for tracking of different types of sample categories
Workflow management
Individual test allocation to analyst A typical workflow process may be: a sample is registered, the supervisor assigns the samples or samples batch to an analyst, analyst conducts the tests and enters observations, results are calculated and the sample is sent for review for decision.
Protocol sheet / Worksheet / analytical work record generation
Concise / exhaustive protocol - indicating all tests to be performed on sample as per the specifications for recording test observations.

Reports

Samples pending for analysis, Samples under analysis Sample Analysis: Analytical readings / observations entry During analysis, the analyst may record sample observations and populate the result online.
Selection of tests for entry of readings / observations
Entry of only the readings and observations Automatic calculation of the results with in-built formula (without giving any external formula for calculations)
Online trending with tolerance values
Out of trend indication at the time of reading entry Operational / validity checks at all possible levels to avoid wrong data entry
Sample Review
Test results can be reviewed and approved subsequently by peer or may redirect the sample for retesting, based on result.
Result Approval
Automatic cross-checking of the results with acceptance criteria checks Automatic decision / flagging about conformance or non-conformance of the sample Automatic incorporation of opinion in Result Approval Report, giving reference to rejection parameters, in case sample is rejected Once the samples are approved, the results are available to export into any industry standard format (Excel, PDF, HTML, RTF, TEXT, etc.) for further analysis and reporting.
Toll samples
Sending sample to an outside lab (in case of breakdown of an equipment during analysis, non-availability of requisite materials, validation etc.)
Label printing - Approved / rejected / discontinued - Discarded
Sample registers For different sample categories
Reports: Sample status reports, Laboratory data, QC productivity report, Analyst performance report
Recipe Management (dynamic production formula) and Stocks Inventory It covers key functional areas of stores and production activities; it enables you to integrate quality control functionality also by providing interfaces with basic LIMS for better management and control of materials and approval. Stocks option covers total activities for inventory management including GRN entry, dynamic product formula, summary of trial details, stock status review, material issues and a list of reports such as GRN / Stock register, issue register, direct consumption register, material bin card, production batch summary.
Trails Summary
This module enables you to store detailed information of trial batches.

Plug-in-Add-on Modules *

Dissolution Profiles

Dissolution profile module helps in evaluating dissolution profiles of samples with complete data analysis including logins using different media / apparatus / speed and time intervals, protocol sheet generation, reading observations entry and calculation of correction factor, result of analysis and data sheet generation. It also allows you to compare and study two dissolution profiles and it is a very useful tool in calculating similarity factor as a measure for assessing the similarity of two dissolution profiles (statistical information can be presented graphically and numerically).

Integrated Stability Scheduling and Studies

Stability module allows scheduling of analysis on different time intervals with various experimental conditions such as temperature and humidity, for selected parameters. It includes stability sample login, stability schedule printing, reading observations entry, online result calculations and finally certification and reporting. The results of the stability study can be plotted collectively on a protocol data sheet with the option of generating information on various environmental conditions and time intervals, both textually and graphically. Stability sample login option for putting rack number and chamber number is provided. Graphs of stability data have facility for plotting data. Stock report of each walk in chamber is available. There is a provision to keep track of stocks including consumption records of stability samples. Option is provided to print stability sample bin card. Pending for stability study is included in alerts and reminders screen.

Stability Trend analysis

Trend analysis provides graphical and tabular representation of resultant data of different batches to study the behavioral trend of a product over a period of time. It generates a comprehensive report as per the user's choice of parameters. Printing report gives a comparative analysis of batches on user-defined parameters along with the specification details in a standard spreadsheet format. In trend analysis, there is an option for extrapolation of trending data along with mean, median and mode. The graph incorporates linear line / logarithmic curve. It comprises of various aspects including sample conditions, sample disposition summaries. This module helps in selection of vendors for approvals based on analytical data and sample data as well.

Regulatory Compliance

21 CFR Part 11 Compliance Validation IQ / OQ / PQ
Audit Trail - Date wise / User wise / Function wise
Computer generated time-stamped, human readable, all operator entries, accurate and complete copies of data, electronic data archiving and ready retrieval.
Document maintenance
In-built Document Management System (DMS) to organize the Lab data and associated documents Standard Operating Procedures, Standard Testing Procedures, Calibration procedures, Maintenance Provision for SOP aging and versioning with tracking for revisions

Facility to import SOPs from stored files (maintained under standard word processor like MS Word, ASCII Text, etc.)

Security
Controlled system access - administrative and automatic system control
Current user sessions - monitoring
User profiles maintenance Password expiry

System Configurations

Internal Messaging System
Mail system for the OasisLIMS users to exchange messages among themselves
Alert / Reminders
Upon log on, due tasks such as retest, equipment calibration are automatically flashed and directed to concerned users by issuing alerts and reminders in the logon screen window
Idle Session Timeout
Idle session by a user exceeds a stipulated maximum period, an automatic timeout takes place and on restoring, the session system demands for user name and password
Account Lockout
On three (3) successive unsuccessful logins, access to OasisLIMS is denied and attempted account is locked automatically by the system. User is prompted to contact the system administrator to unlock and re-activate the account. System keeps record of the accounts and passwords tried by the suspect for administrative purposes.
Email System
OasisLIMS has online emailing facility that enables users to email reports produced by the system amongst themselves in a closed user group (LIMS) or external users, for this it avails the services of existing mail server
Backup and restore
Year transition system
Export Reports
Every report produced by the system can be exported online in various industry standard formats such as Excel, PDF, HTML, RTF, Text, etc. to meet information exchange requirements of users working with different software systems.

True-LIMZ CTL

LAB DATA MANAGEMENT FOR COMMERCIAL / PUBLIC TESTING LABORATORIES WITH INTEGRATED INVOICING MODULE

LIMS for Drugs, Food, Bewerages, Textiles, Plastic ware, Toys, Food Contact Containers/packaging, Jewelary ... Testing

True LIMZ with integrated billing management module is the most critical tool in the operations of commercial and public test laboratories offering analytical services. Virtually everything from sample receipts to sample disposal is tracked through the True LIMZ. And, all of our laboratory locations are operating and standardized to the same LIMS.

When it comes to managing a public / commercial laboratory service, getting procedures done on time and accurately is only part of the total equation. After sample records have been acquired, tests have been run, and results compiled, clients have to pay for the work performed. In the modern testing / analytical services landscape, executing billing practices correctly might be equally time-consuming and labor-intensive than any other part of the job in laboratory. But with True LIMZ solution laboratories can easily interface with their billing systems directly from their laboratory information management system, it’s possible to gain greater efficiency and incredible cost savings. True LIMZ is also responsible for storing all client quotes and billing information. This includes all contract pricing, discounts, turnaround surcharges and even special client billing requirements. This assures accurate billing based on quotes and contracts.

Some salient features at a glance …

Master data planning and entry
Product master / Material master
Entry of relevant details of different Raw materials / packaging materials / intermediates / bulk etc. in product master
Test master (pre-shipped with OasisLIMS)
Defining 'n' number of tests which are performed on a sample
Reports: Material master, Vendor master, Test master
Product - test - test method links
Establishing link among product, its tests (as per the monograph) and the test methods required to carry out the tests Limits Defining different types of limits
Report: Product composition details
Report: Specifications - RMs / FPs / PMs / Intermediates / Bulk etc.
Transaction processing
Sample registration and login for various sample categories: Regular / retest / R & D / pre-shipment etc Automatic AR number generation for different types of samples categories Entry of quantity received in multiple pack sizes / containers Entry under sampling plan, for multi lot / multi assay and mean result calculation on the certificate of analysis
Labels printing
Protocol sheet / work sheet / analytical work record generation Concise / exhaustive - indicating all tests to be performed as per the pharmacopoeia, the in-house specifications; the regulatory requirements / Drugs and Cosmetics Act and the Rules and user defined formats for entering readings / observations Samples pending for analysis Samples under analysis Analytical readings / observations entry Selection of tests for entry of readings / observations Entry of only the readings and observations Automatic calculation of the results (without giving any external formula for calculations) Generation of certificate of analysis (COA) Automatic cross-checking of the results with both official as well as in-house specifications Automatic decision about conformance or non-conformance of the sample Automatic generation of certificate of analysis as per the pharmacopoeial requirements and schedule V of the drugs and cosmetics rules (Old COA with old specifications and current COA with current specifications) Automatic incorporation of opinion in the COA, giving reference to rejection parameters, in case the material is rejected
Report: Certificates pending for printing
Sample registers RMs / FPs / Rejection / PMs etc. for different sample categories Reports: Sample status reports Laboratory data QC productivity report Analyst performance report
Retention Sample Management
After testing for all properties some amount of sample will be kept for retention for some period. The information of retention sample can be maintained properly mainteined in LIMS add-on functions.

Billing and Accounts /Sales Statements

Product Party Rate
There is a provision to enter product testing rates for each party product wise, the rate defined under this option appear as default at the time of processing billing.
Bill Processing
The system itself incorporates samples processed on bill date on the basis of party; system can be configured to automatically generate Bill No. On the basis of user defined theme. Provision is there to enter discounts, bill wise. Service tax can be calculated and evaluated automatically.
Bill View/Update facility
Billing system provides a facility to search bills detail on various descriptive identifiers such as Bill No., Date and Client. Provision is there to zoom in up to the bill voucher to review details, make amendments, in case needed and finally print.

Bills Printing / Pending Bills

Bills may be printed in a user-desired format; option is available to print bills on pre-printed or ordinary stationary. There is a provision of high-speed bill’s printing on DMP (dot matrix printer) to handle voluminous jobs efficiently, or attractive/profession billing with the support of desk jet/laser printer. There is a separate report that provides information on bills pending for billing.
Receipts
There is module to enter receipts against bills generated on client’s account to track payment receipts. System provides a facility to search bill detail on various descriptive identifiers such as Bill No., Date and Client. Provision is there to zoom in up to the bill voucher to review details, make
Monthly Accounts Statements
Monthly report is available comprising all the transactions held during the month of a particular party with complete details and ledger account statement can be generated in a specific format for a client for a particular duration.
Outstanding Statement
An outstanding report can be generated incorporating previous dues, current billing amount, receipts and total due on a particular date.
Export Reports
Every report produced by the system can be exported online in various industry standard formats such as Excel, PDF, HTML, RTF, TEXT etc. to meet information exchange requirements of users working with different software systems.

Standard Workflow …

A summary of standard workflow is given below ____

  • Enquiry Generation
  • Feasibility Studies Confirmation
  • Quotations
  • TRF (Test request form)
  • Sample Registration
  • Sample Allocation (department wise) / Sampling Quantities
  • Sample Labels / Group Worksheets
  • Reading Observations and Results Entry
  • Lab Department Approvals
  • QA Approvals
  • CoA, Printing and Release for Invoicing
  • Sample Tracking and Other reports
  • Invoicing Module
  • Sales Statements and Reporting
Enquiry Generation
New sample enquiries received from various prospects are registered here with the reference no. and sample test requirements.
Feasibility Studies Confirmation
These sample enquiries are transferred to various lab departments handling specific tests analysis for approvals on feasibility of analysis.
Quotations
Once the test feasibility received from respective departments, the case moves to commercials and quotations are worked out for enquired sample, test wise, group tests wise, specification wise etc.
TRF (Test request form) / Sample Receipts
On receipt of samples a TRF is prepared against quotations, multiple quotation references from a client can be pulled in this process with other T/C and agreements confirmations. TRF completion leads to automatic sample registration with unique no. of individual analysis.
Sample Registration
Provision for direct Sample registration is also available where sample, client, tests (from standard specifications), additional tests can be selected/allocated, other references regarding sample with the option for CoA report selection from custom designed format (pre-configured CoA) is also available.
Sample Allocation (department wise) / Sampling Quantities
Sample is automatically allocated to department head for further resource allocation with sample quantities details; department head allocates sample tests specific to department to qualified analysts for processing jobs.
Sample Labels / Group Worksheets
On allocation of sample tests, bar coded labels and group worksheets can be generated indicating all the tests to be performed on sample specific to department.
Reading Observations and Results Entry
After analysis, observations and results entries can be submitted for individual test for their subsequent approvals at department level.
Lab Department Approvals
Lab department head reviews and approves the results with the provision of electronic signature (optionally available) attachment.
QA Approvals
Once the sample processing is complete, QA department authorizes and approves the final results in 2/3 steps (optional), review, authorize and approve with electronic signature (optionally available).
CoA, Printing and Releasing sample for Invoicing
CoA can be printed in custom designed reporting form as per requirement with ES underneath, emailed also, now it becomes available to be billed to party as pending for invoicing.
Sample Tracking and Other reports
Various reports are available to track sample status and other sample processing related information.
Invoicing Module
Samples processed are opened for billing at this stage, provision for quotation details are also available while preparing invoices for quick references. Invoices generated can be emailed or printed after proper authorizations.
Sales Statements and Reporting
Sales summaries/statements, periodic reports are available comprising all the billing transactions held of a particular party with complete details and account statement can be generated in a specific format for a client for a particular duration.

Stabi-M, Stability Data and Studies Management Software

INCREASE PRODUCTIVITY AND MAINTAINS QC/QA COMPLIANCE LEVELS

Specifically desiged for Pharmaceutials, API's and Chemicals manufacturing/development Laboratories

Stability Studies Management software is fully complaint system for scheduling, and maintaining stability programs for manufactured products and product that are on research development, it manages complex studies with multiple storage conditions, packaging sizes, packing types, and orientations of batches. It provides a consistent toolset to standardize and perform required statistics throughout the stability program and supports the complete activities of highly regulated stability operations as outlined in ICH guidelines by automating the process of executing sample studies under various experimental conditions over an extended period of time. Stability data are critical to the product development and on-going quality control of products of various dosage forms. Stability studies data analysis form the foundation for specification limits, expiration dates and storage conditions and play an important role in managing continuous product and process improvements and in indicating product quality on a batch-to-batch, lot-to-lot basis.

Key functional capabilities include:

Stability study protocol design includes business rules (experiment conditions / intervals etc.), Stability chambers, locations, conditions and inventory management, stability study and protocol execution (schedules, workflows, etc.), Stability testing/result entry, reviews, Dashboard management review of study progress, schedules and trending result, alerts and reporting

Stability Major Process Incorporates …

  • • Studies for exhibit / commercial batches, accelerated / intermediate / long term studies
  • • Excursion Studies
  • • Photo-Stability
The following figure shows the standard process flow outlining the stability module:


  • • Master Data Management
  • • Specification / Inspection Management System
  • • Stability Protocol Design for different types of studies
  • • Stability Studies Samples Management
  • • Reports and Reviews
  • • User Administration

Masters data Management

Product master / Material master (pre-shipped with OasisLIMS) Entry of relevant details of different finished products (stability) in product master Test definition and management (pre-shipped with Stabi-M) Defining 'n' number of tests which are performed on a sample Reports: Product, Product Alias, Vendor/Manufacturer, Test master
Specifications and Miscellaneous Masters
Mainly deals with maintenance of specifications, tests and subsidiary masters such as Product test links/specifications, new specification can be added, existing specifications can be edited, inquired and deleted, as the case may be.
Product - test - test method links (pre-shipped with Stabi-M)
Establishing link among product, its tests (as per the monograph) and the test methods required to carry out the tests
Limits
Defining different types of limits Concurrency control on master data updation Provision for maintaining history of Specification with revisions is available under specifications history/revisions. Copy specifications mode is used as a tool to copy the product test links of one product for another, if their specifications are same. There is an option for rearranging test parameters to set the order of their appearance on work sheet and certificate of analysis as well. Report: Specifications
Stability Studies Subsidiary Masters
Pack Size master, Orientation master, Experimental Conditions master, Stability Chambers master, Pack Type master

Stability Studies Protocol Design

Stability Protocols Design… flexible and comprehensive Stability Studies and Schedules Pulling, Stability protocol Stability module allows scheduling of analysis on different time intervals with various experimental conditions such as temperature and humidity, for selected parameters. Sample Quantities kept for stability studies, provision for rack number and chamber number is provided, reason for stability studies Provision for multiple strength, Type of study; Excursion, photo-stability, Introduction of brackets / matrixes Concept, Data entry window period, Conditional Initial Login, provision for Intervals in Months, days and hours, general Information, intro, objective, scope, responsibility, plan etc. Flexible test selection at cross point station / interval and experimental condition, Station-wise/Interval sample quantity, total sample quantity, Racks and Chamber Linking Protocol Revisions / Detailed Stability Protocol Report

Batch loading

Multiple Batch loading on single protocol, Validation, Commercial Batches, References; BPR, BMR, API Source, AR No. etc., Charge Date, Charge up-to Months, Mfg./Exp. Dates, Shelf life, Expiry remarks for Validation batches, Markets and Customer
Schedule Sample pulls from Stability chambers
On the basis of specific time schedules and environmental conditions defined in stability studies protocol workflow, stability analysts and managers can see the upcoming sample pulls (due dates, withdrawal samples and locations etc.) in a dashboard reminder with all the other stability program events and easily manage execution of stability sample for given time intervals and conditions as per guidelines.

Stability Sample Life Cycle

It includes sample pre-registration, stability schedule printing, reading observations entry, on-line result calculations and finally certification and reporting. Stability Sample registration and login, on the basis of product, batch, pack type, size, orientation. Automatic AR number generation on user defined themes. Entry of quantity sampled, login date, by etc. Stability Label printing – Storage/Laboratory sample Provision for Partial analysis/Reduced testing

Dynamic Work sheets / analytical work record generation
Concise / exhaustive - indicating all tests to be performed as per the pharmacopoeia, the in-house specifications; the regulatory requirements / Drugs and Cosmetics Act and the Rules and user defined formats for entering readings / observations Stability Samples pending for analysis Stability Samples under analysis Stability Samples pending for withdrawal Analytical readings / observations Results entry Selection of tests for entry for results entry, user two modes Flexible results entry, sequential one after the other tests or single screen multiple entries Generation of certificate of analysis (COA) Automatic cross-checking of the results with both official as well as in-house specifications Automatic decision about conformance or non-conformance of the sample Automatic generation of certificate of analysis as per the pharmacopoeial requirements and schedule V of the drugs and cosmetics rules (Old COA with old specifications and current COA with current specifications) Automatic incorporation of opinion in the COA, giving reference to rejection parameters, in case the material is rejected

Report: Certificates pending for printing
Stability studies OOS / OOT handling
As per current regulations, OOS and OOT are prime considerations in long term product stability and improvisations, Stabi-M has built-in Out of Specification (OOS) alert messaging during cross validation with the limits specified. OOT trends can be determined using stability sample result of current batch with tolerance limits or comparing results with reference batches. Data from recent pulls are automatically attached to the study set with desired results and calculations, this helps reveal OOS or OOT data for timely decision making through investigations and finding the root cause for further actions.

Sample registers
Reports: Protocol report, Stability Schedule Reports (Complete, Date Wise, Product Wise) Certificate of Analysis (CoA), Stability Labels, Stability Status/Register, Stability Protocol Data, Stability Summary Report (Interval), Stability Summary Report (Tests), Stability Trending and Graph, Stability Samples List, Stability Stock Bin Card, Stability Grid, Stability Discontinued, Sample Charged In

Stability Studies Graph and Data Trending
The results of the stability study can be plotted collectively on a protocol data sheet with the option of generating information on various environmental conditions and time intervals, both textually and graphically.

Statistical Stability Data

Study data can be processed using on-board analytics and statistical capabilities, which include expiration date analysis using regression, statistical modeling, Regression Analysis with Stability Prediction Integrated with-in Stabi-M application Surface Embedded Excel – Single application look and feel experience Real-time stability results data capturing on various intervals 3,6,9,18,24 … Statistics graphs generation on following themes Logarithmic / extrapolation / Linear / Polynomial Graphs of stability data have facility for plotting data.

Stability Studies – Sample Quantity Tracking

All samples and their environmental conditions are automatically tracked and traced using built-in inventory management capabilities. There is a provision to keep track of stocks including consumption of records of stability samples. Option is provided to print stability sample bin card.

Stability Studies Reports

You can print Stability Schedule Reports (Complete, Date Wise, Product Wise), Certificate of Analysis (CoA), Stability Labels and Stability Status/Register etc. Data analysis includes Stability Summary Report (Interval), Stability Summary Report (Tests), Stability Trending and Graph. Queries can be made on screen and printed, in case desired, Stability Samples List, Stability Stock Bin Card, Stability Grid etc.

MIS - Management Information System

Strong MIS includes on line queries with respect to Samples pending for Stability Samples pending for Stability Analysis, CoA pending for review, CoA pending for printing.

Stability Studies – System Alerts and Reminders

Alerts and reminders screen, pending for analysis, pending for registration, pending for CoA review, pending for CoA printing

Special Features

Manufacturer Information, Packaging Information Provision for rescheduling analysis, some day’s adjustment (deferred analysis)

Administration and Security

Administration has user specific options to take up user profiles maintenance, implement controlled system access to various functions of system, defining authorized users their profiles including UID and password to access. The system administration functions includes creation of roles, allocating roles to users (granting rights) depending upon individual’s responsibilities. Handling current user sessions – monitoring, other routine activities such as logout, apply free lock to hold session, password expiry, changing passwords, establishing mailing system, alerts and reminders etc. Data backup/restore operation is available under data maintenance option.

Audit Trails

A comprehensive audit trail over the course of the stability study
HELP/ WINDOWS
Stabi-M comes with on-line help, answer to all your questions. A complete reference guide of the package providing with step-by-step procedure of individual function available under Stabi-M . It also has on-line personnel training system (PTS), which details about features and functions of the system with screens and description of each step.

Stabi-M add-on modules

Plug-in-Add-on Modules *

Seamless Integration with OasisLIMS

Stability Study application can be implemented as a stand-alone deployment or can be seamlessly integrated to existing OasisLIMS installations that do not have a comprehensive stability study management capability. Under integration set-up a standard pool of functions including masters may be taken from OasisLIMS such as products, tests, specifications etc. and built-in standard workflow functionality to execute stability samples enable in-house system administrators to create specific stability study workflows supporting ICH Guidelines for testing, trending and analytics.

Oasis-DMS, Enterprise Document Manamgement System, Integration Ready with LIMS

SUITABLE IN MANUFACTURING, RESEARCH DEVELOPMENT, SERVICE LABORATORIES ENVIRONMENTS

Oasis-DMS is an Enterprise Document Management (EDM) platform for creating, capturing, managing, delivering, and archiving documents and contents. Oasis-DMS also integrates seamlessly with OasisLIMS – Laboratory Information Management System. Ir empowers seamless collaboration, communication and sharing across and beyond the Enterprise. DMS (Documents Management System) collabrative functions cover full electronic document life cycle execution ...

Manufacturing procedures / STP / SOP /calibrations / Specifications / Safety documents etc. It simplifies the process of capturing and managing documents data with a comprehensive suite of editing tool.

OASIS-DMS RECORDS MANAGER / COLLABORATIVE WORKFLOW

DMS integrated into LIMS simplify the process simplify the process of capturing / editing and maintaining documents and contents with in a comprehensive suite.

Folders Management
Folders Creation, Sub-folders, nested, Efficient Organization of Documents, MS Like Native - files management system
Documents
Creation of Documents, User defined Header / footer parameters under standard templates, Built-in word processor capabilities, Document Categories.
Import Existing Documents, no need to re-create
Upload documents directly, Capturing files with comprehensive tools, Preserved formatting, AS_IS, Huge saving in time and efforts
Approvals and Authorization
Configurable Review, Approval levels, Incorporation of e-Signatures, Provision for marking and repeated revision, Document life-cycle – draft to final
Controlled Access
Storage in database, Access to documents controlled, Control on the basis of documents category, Configurable docs access to a user/or a group
Publishing and Distribution
Docs publishing in .PDF format, Circulation of docs controlled …, Documents Viewer, View Only, Master, control copies printing, Provision for barcodes printing
Approvals and Authorization
Configurable Review, Approval levels, Incorporation of e-Signatures, Provision for marking and repeated revision, Document life-cycle – draft to final
Version Controls on Revisions
Provision for version controls, Next Reviews, Change control reference / revision reason, Access to historical data / files
Integration
Integrated with LIMS, QMS Integrates seamlessly with other enterprise applications

Dashboards / Alerts - Reminders

Home screen management dashboards, Category / department wise consolidations, Automatic alerts on due/pending actions, Review due, pending approvals

OasisLIMS Integrated DMS - Document Management Module, Limited Edition

SUITABLE IN LABORATORY ENVIRONMENTS

Document and data management module integrated with LIMS - Laboratory Information management Systems that simplifies the process of capturing documents and data with a comprehensive suite of tools a step towards managing STP/SOP information in electronic form i.e. paperless documentation. The volume of information a lab generates presents a challenge for lab management to organize properly with access control, QA department and scientists are required to correctly store and catalogue the STP’s / SOP’s and various other documents they create. The first key concept to describing a DMS in a laboratory environment is implementation of electronic document management for segregating published and non-published documents. Successful document management in a laboratory setting requires, at a minimum, proper procedures for the following events;

Version control / Change control / Document view / Distribution (published, un-published)

Document Management Link is a function within OasisLIMS activities for managing many different types of controlled documents such as SOPs (Standard Operating Procedures), standard testing procedures (STP’s), Safety documentation, Calibration Procedures, Specifications - MOA (method of analysis) etc. It is possible to link documents from such applications as ...

Microsoft Office (.doc/.docx) Text Files / ASCII Adobe Acrobat (.pdf)

Role of Oasis DMS - Document Management in a Laboratory Environment
Successful document management in a laboratory setting requires, at a minimum, proper procedures for the following events: Version control, Change control, Document review, Authorizations, Distribution Document Management Link can be a function within LIMS for managing many different types of controlled documents such as SOPs (Standard Operating Procedures), Safety documentation, Product specifications, etc. It is possible to link documents from such applications as Microsoft Office, Adobe Acrobat, ASCII, Picture/scanned etc.

In present regulatory scenario specify electronic record management is not only storage of analyte results data in database but also a full archive of analysis related information such as chromatograms, spectra, raw data files and more… The mass of information a lab generates comes with a major challenge to lab management to oragnaize information with quick retrivals on the event of auditing and inspections.

Analyst are required to correctly store and catalogue the results and reports they create. In the past this information was paper printed, which resulted in huge storage and tracking issues. In addition, the opportunity to share vital data across enterprise with others user groups was not happening. Valuable information was not communicated, and had no means to disseminate the information was available with labs. Key function of Oasis LIMS - DMS module is storage and retrieval of Finished Products Specifications, Raw Materials Specifications, Standard Operating Procedures, Standard Testing Procedures, Calibration procedures with importing facility from industry standard formats (ASCII text, MS-Word) Provision for SOP ageing and versioning with tracking for revisions