OasisLIMS 4.0 Enterprise

AN CUSTOM DESIGN SOLUTIONS 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

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.

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

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

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.

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