LIMS FOR PHARMACEUTICAL PRODUCT DEVELOPMENT AND R&D ENVIRONMENTS
Specifically Custom Design 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.)
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.
