Stability Study Management Software(softLIMS)

Pharma Soft Sol is a leading provider of GxP-compliant software solutions for the pharmaceutical, biotech, and life sciences industries. With a strong focus on regulatory compliance, digital transformation, and data integrity, Pharma Soft Sol offers a comprehensive suite of applications including QMS, LIMS, DMS, LMS, and EBMR, all developed on a robust Java-based platform.

Our flagship softLIMS solution is designed to streamline laboratory operations while ensuring full compliance with GMP, GLP, 21 CFR Part 11, Annex 11, and WHO guidelines. One of the key modules of softLIMS is the Stability Study Management System, developed to manage the end-to-end stability testing process efficiently and compliantly.

Introduction to Stability Study Management

Overview

The Stability Study Management Software is an integrated module within the softLIMS suite that manages the complete lifecycle of stability studies for drug products and drug substances, from study design to result evaluation and report generation.

Pharmaceutical companies are required by global regulatory agencies (such as USFDA, EMA, MHRA, and WHO) to establish the stability of their products to ensure quality, safety, and efficacy throughout the product’s shelf life. The software simplifies this complex process by providing an automated, compliant, and traceable system for planning, scheduling, monitoring, and documenting stability studies.

Scope

The module supports:

Drug Product and Drug Substance stability studies (accelerated, long-term, intermediate)
ICH-compliant study design and execution
Chamber and condition monitoring integration
Automated scheduling of pull points and sample testing
Result entry, review, and trending
Final stability reports and shelf-life determination

By digitizing and integrating every step, the Stability Study Management Software helps laboratories eliminate manual errors, reduce administrative workload, and ensure data integrity.

Software Details and Functional Capabilities

Core Functionalities

Study Protocol Design
- Create and approve stability protocols aligned with ICH Q1A guidelines.
- Define parameters such as product, batch, study type, storage conditions, and test intervals.
Sample and Pull Point Management
- Automated creation of pull schedules based on protocol design.
- Sample labeling and tracking throughout storage, testing, and reporting.
Storage and Chamber Management
- Define and manage stability chambers and conditions (e.g., 25°C/60% RH, 40°C/75% RH).
Test Execution and Result Management
- Data entry, review, and approval workflows per 21 CFR Part 11 requirements.
- Trend analysis and result comparison across batches and studies.
Reports and Data Analysis
- Generate interim and final stability reports.
- Perform data trending, shelf-life prediction, and graphical analysis.
Audit Trail and Security

Role-based access control with digital signature support.
Compliance with 21 CFR Part 11, Annex 11, and ALCOA+ principles.

Key Features and Advantages

Key Features

Centralized repository for all stability studies.
Customizable templates for study protocols and reports.
Integration with LIMS, QMS, and Instrument Management modules.
Automatic pull schedule reminders and notifications.
Real-time status dashboard for ongoing studies.
Configurable study types (e.g., accelerated, long-term, photostability).
Controlled workflow for review, approval, and data authorization.
Seamless integration with laboratory instruments and environmental data systems.

softLIMS - Stability Management System

от Pharma Soft