Stabi-M, Stability Data and Studies Management Software
INCREASE PRODUCTIVITY AND MAINTAINS QC/QA COMPLIANCE LEVELS
Custom Design Solutions 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 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.
