Stability Data and Studies Management Software – Oasis LIMS

What is Stability Data and Studies Management Software?

Stability Studies Management software offers a comprehensive solution for efficiently managing stability programs related to both manufactured products and those in research and development. It excels in handling intricate studies that involve various storage conditions, packaging sizes, packing types, and batch orientations. This software provides a reliable set of tools to standardize procedures and conduct necessary statistical analyses throughout the entire stability program. It seamlessly supports all the activities associated with highly regulated stability operations, aligning with the guidelines set forth by ICH.

By automating the execution of sample studies under different experimental conditions over an extended timeframe, this software ensures precision and consistency in managing stability data. These data are of utmost importance in product development and ongoing quality control for a wide range of dosage forms. They serve as the basis for defining specification limits, determining expiration dates, and establishing suitable storage conditions. Moreover, they play a pivotal role in overseeing continuous product and process enhancements and assessing product quality on a batch-to-batch and lot-to-lot basis.

Key functional capabilities include

• Stability study protocol design: Business rules for experiment conditions and intervals
• Stability chambers: Selection of appropriate chambers
• Locations: Determining suitable locations for stability testing
• Conditions: Establishing the required environmental conditions
• Inventory management: Managing and tracking inventory for stability studies
• Stability study and protocol execution: Creating schedules and workflows
• Stability testing/result entry: Conducting stability tests and recording results
• Reviews: Regular review of stability study progress
• Dashboard management: Monitoring and managing study progress through a dashboard
• Study progress: Tracking schedules and trending results
• Alerts: Setting up alerts for critical events or deviations
• Reporting: Generating reports on stability study outcomes

Stability Major Process Incorporates

• Studies for exhibit / commercial batches, accelerated / intermediate / long term studies
• Excursion Studies
• Photo-Stability
• 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

• Specifications and Miscellaneous Masters: Primarily involves the upkeep of specifications, tests, and related master data, including product test links and specifications. New specifications can be introduced, while existing ones can be modified, examined, or removed, depending on the circumstances.
• Product - test - test method links (pre-shipped with Stabi-M): Creating connections between a product, its tests based on the monograph, and the necessary test methods for conducting those tests.
• Limits: Various types of limits can be established, and concurrency control is applied to manage updates to master data. Additionally, there is a provision for preserving the history of specifications along with revisions within the specifications history/revisions section. The "Copy specifications" mode serves as a tool for duplicating product test links from one product to another when their specifications match. Moreover, an option exists for rearranging test parameters to determine their order of presentation on worksheets and certificates of analysis.
• Stability Studies Subsidiary Masters:
  • Pack Size master
  • Orientation master
  • Experimental Conditions master
  • Stability Chambers master
  • Pack Type master

Stability Studies Protocol Design

• Design of Stability Protocols: Flexible and comprehensive approach
• Stability Studies and Schedules Pulling:
• Stability module for scheduling analysis
• Different time intervals
• Various experimental conditions (temperature, humidity)
• Selected parameters
• Sample Quantities for Stability Studies: Provision for rack number and chamber number
• Reasons 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
• Time Intervals: Months, days, and hours
• General Information:
  • Introduction
  • Objective
  • Scope
  • Responsibility
  • Plan, etc.
• Flexible Test Selection:
  • Cross-point station/interval
  • Experimental condition
• Station-Wise/Interval Sample Quantity
• Total Sample Quantity
• Racks and Chamber Linking
• Protocol Revisions/Detailed Stability Protocol Report

Batch loading

• Stability studies protocol workflow defines specific time schedules and environmental conditions.
• A dashboard reminder displays upcoming sample pulls.
• Information includes due dates, sample withdrawal details, and locations.
• This helps stability analysts and managers manage stability samples.
• Samples are executed based on guidelines, considering time intervals and conditions.
• The dashboard also tracks other stability program events.

 

Stability Sample Life Cycle

• Components of the process:
  • Sample pre-registration
  • Stability schedule printing
  • Reading observations entry
  • Online result calculations
  • Certification and reporting
• Stability Sample registration and login criteria:
  • Product
  • Batch
  • Pack type
  • Size
  • Orientation
• Automatic AR number generation with user-defined themes
• Information entry fields include:
  • Quantity sampled
  • Login date
  • Responsible personnel
• Stability label printing for storage and laboratory samples
• Provision for partial analysis or reduced testing

 

Dynamic work sheets / Analytical work record generation

• Perform all tests according to:
  • Pharmacopoeia
  • In-house specifications
  • Regulatory requirements (Drugs and Cosmetics Act)
  • User-defined formats for recording readings/observations
• Manage various types of Stability Samples:
  • Samples pending for analysis
  • Samples under analysis
  • Samples pending for withdrawal
• Record Analytical Readings/Observations
• Enter Results
• Select tests for entry using two modes:
  • Flexible results entry
  • Sequential entry or single-screen multiple entries
• Generate Certificate of Analysis (COA)
• Automatically cross-check results against official and in-house specifications
• Automatically determine sample conformance or non-conformance
• Automatically generate COA compliant with Pharmacopoeial requirements and Schedule V of Drugs and Cosmetics Rules
• Automatically include opinions in the COA, referencing rejection parameters for rejected materials.

Stability studies OOS / OOT handling

• OOS and OOT are vital factors in long-term product stability and enhancements.
• Stabi-M incorporates an OOS alert system during cross-validation, following defined limits.
• OOT trends are assessable by comparing stability sample results of the current batch with tolerance limits or reference batches.
• Recent pull data is automatically added to the study set, aiding in the detection of OOS or OOT data.
• This facilitates timely decision-making through investigations and root cause analysis for necessary 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

• Stability study results can be displayed on a protocol data sheet.
• The data sheet allows for plotting results collectively.
• It offers options for generating information on:
• Different environmental conditions
• Various time intervals
• Information can be presented both textually and graphically.

Statistical Stability Data - Data processing options:

• On-board analytics and statistical capabilities
• Includes expiration date analysis using regression and statistical modeling
• Regression Analysis with Stability Prediction Integrated within Stabi-M application
• Surface Embedded Excel for a unified application experience
• Real-time stability results data capture at intervals: 3, 6, 9, 18, 24 ...
• Statistics graphs generation with themes: Logarithmic, extrapolation, Linear, Polynomial
• Graphs for stability data with plotting capabilities

Stability Studies – Sample Quantity Tracking

• Automatic tracking and tracing of all samples and their environmental conditions
• Built-in inventory management capabilities for samples
• Ability to monitor stock levels and record consumption of stability samples
• Option to generate printed stability sample bin cards

Stability Studies Reports

• Print various reports: Stability Schedule Reports (Complete, Date Wise, Product Wise), Certificate of Analysis (CoA), Stability Labels, and Stability Status/Register.
• Perform data analysis, including Stability Summary Report (Interval), Stability Summary Report (Tests), Stability Trending, and Graph.
• Generate queries for on-screen viewing and printing of Stability Samples List, Stability Stock Bin Card, Stability Grid, etc.

MIS - Management Information System

Robust MIS features online queries for:

• Samples awaiting stability testing
• Samples awaiting stability analysis
• Certificates of Analysis (CoA) awaiting review
• Certificates of Analysis (CoA) awaiting printing

Stability Studies – System Alerts and Reminders

Special Features

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

Administration and Security

The administration offers user-specific features for managing user profiles, controlling access to different system functions, and configuring authorized users' profiles, including their unique user IDs and passwords for access. System administration tasks encompass the creation of roles, assignment of roles to users (granting permissions) based on individual responsibilities, managing ongoing user sessions by monitoring activities like logging out, applying session locks, setting password expiration policies, updating passwords, establishing email systems, and managing alerts and reminders. Additionally, data backup and restore operations are accessible through the data maintenance option.

• Audit Trails: A thorough record of all activities conducted throughout the duration of the stability study.
• HELP/ WINDOWS: Stabi-M offers comprehensive support through its online help feature, addressing any inquiries you may have. It includes a thorough reference guide encompassing step-by-step instructions for each function within the Stabi-M package. Furthermore, it features an online personnel training system (PTS) that provides detailed insights into system features and functions, complete with screen visuals and step-by-step descriptions for effective training.
• Stabi-M add-on modules: Plug-in-Add-on Modules

Seamless Integration with OasisLIMS

The Stability Study application can be employed in two ways: as a standalone deployment or as a seamless integration into existing OasisLIMS installations lacking comprehensive stability study management capabilities. In the case of integration, you have the option to draw upon a standardized pool of functions, including masters, from OasisLIMS, such as products, tests, and specifications. This integrated approach also incorporates built-in standard workflow functionality, facilitating the execution of stability samples. It empowers in-house system administrators to craft customized stability study workflows that align with ICH Guidelines for testing, trend analysis, and analytics.