Pharmaceutical stability management software is designed to help pharmaceutical companies monitor, manage, and maintain the stability of their drug products. It offers a range of features to ensure compliance with regulatory requirements and the quality and safety of pharmaceutical products. Here are some common features of pharmaceutical stability management software:
Study Management
Stability Study Management
- Study creation: Defines the study protocol including definition of storage conditions, timepoints, required or conditional testing, test groups, inventory sets and pulls, test schedules, and acceptance criteria.
- Sample management: Tracks and manages the storage, labeling, and distribution of stability samples.
- Test planning: Schedule stability tests and retests based on predefined protocols. Work request system for calendar view or email notifications.
- Data Entry and Recording: Assures accurate formats, lists entries, precision, and verified against specification criteria.
- Libraries: Define generic study types as libraries to quickly and reproducibly create new studies.
Specifications
An important part of setting up a stability study is assigning a specification. These specifications do the following:
- Define the required testing for a product or formulation
- Define warning limits and acceptance criteria for textual or numeric results
- Specify the precision of numeric result OR specify the allowed values for textual results
- Secure workflow for reviews and approvals.
Test Processes
- Record your test information directly in Templated test documents to eliminate paper from your stability processes.
- Includes proforma sample & standard preparation, automated calculations, instrument interface, references to materials and equipment with full audit trail and electronic signature.
- Secure workflow for reviews and approvals.
Reporting
- Trend analysis reports to monitor stability data over time, helping identify potential issues or deviations.
- Statistical tools for analyzing stability data and calculating shelf-life estimates.
- Stability reports compliant with regulatory standards, such as ICH guidelines.
Dashboard
- Visual display for real-time monitoring of stability studies, including status, test completion, and deviations.
- Automated alerts and notifications for scheduled inventory transaction, scheduled tests, deviations, and out-of-specification results
Sample Management
Comprehensive stability sample management including: location tracking, chain of custody, barcode scanning, inventory transaction scheduling an logs, and sample workflow with electronic signatures to capture status change.
Document Repository
- Store and manage stability study-related documents, including protocols, reports, and certificates of analysis.
- Maintain version control for documents and ensures that the latest versions are used in stability studies.
Instruments
Integration with Laboratory Instruments
- Instrument connectivity: Integrates with laboratory instruments for automated data capture, reducing manual data entry errors.
- Data import/export: Allows for seamless data import and export with various file formats and systems.
User Access
User Access and Security
Role-based access control: Provides role-based permissions to control access to different system functions and data.
Sequence Visualization
A browser based sequence viewer eliminates the need for reviewers, approvers and decision makers to access & navigate the chromatography system.
A simple, demo version of SciCord’s SciChrom Viewer is accessible below. A guide is also available if you need more information about how SciChrom Viewer works.
SciChrom Viewer is meant to be used on a full desktop/laptop (not phone/tablet) and on the Chrome, Edge, or Firefox browsers. Please use one of these devices/browsers.
You can also download the user guide if you want to get an idea of how SciChrom Viewer works but don’t have access to a computer.
If you want a more technical discussion about stability in general, you can
read more here.
