Challenges with Current Stability Excel based Process
For decades, the pharmaceutical industry has been managing its business by focusing most of its resources on the subsequent drug. With the changes in regulations, declines in drug approvals and a shift towards developing high value biologics, today’s manufacturers begin to refocus and address current processes, practices and systems, and take a hard line on improving their overall quality and compliance efforts. Here is where the stability management system comes into the picture. The persistence of stability testing in pharmaceutical industry stands to be a key procedural component in the present pharmaceutical development program for a new drug as well as new formulation.
But using paper-based forms, disconnected systems, or manual processes to manage, track and report on quality issues and actions does not provide effective solutions for implementing harmonized, integrated quality management processes, which follow industry best practices. Data maintenance in Excel Spreadsheets or an Access database can be very time consuming, error prone task which may lead in most expected outcome very rarely. Also Version control of the spreadsheets can become an issue and it is nearly impossible to perform any meaningful analysis across multiple spreadsheets.
AmpleLogic Stability Management System
AmpleLogic introduces Stability Management Module exclusively created for pharmaceutical firms, records all the conditions under which a study is conducted and keeps track of the stability chambers available. The Stability system provides complete control of stability studies for a variety of industries that includes creation of the stability protocol with its various notes, required fields and imported documents. A set of standard reports are delivered through the module for reporting of the stability protocol and its associated results.
- A single strategic platform for all quality control and assurance activities
- Leverages industry best practices with industry and government regulations and ISO standards
- A distinct console system to comprehensively manage product specifications and control limits
The system manages the Stability Plan and Testing, enabling customers to define the test parameters for stability studies, including sampling time points, package types, and test methods. It is a fully Part 11 compliant, with a complete audit trail that is easy to read and search. The system is simple enough to check who corrected a typo and powerful enough for in-depth auditing by QA/QC. It helps to generate submissionready stability data summaries within a click of a button.
AmpleLogic Stability Module is executed either in Phase wise or full version. The implementation process can be done just in 2 Weeks thru a 100% validated system with 21 CFR Part 11 Compliant.
Product Stability automation Module Features
Benefits with Stability Schedule, Results Recording and Tracking software
- Implements a closed-loop quality system consistent with FDA and other industry best practices /li>
- Provides flexible data-drive workflow, that ensures compliance with standard operating procedures, eliminates manual, error-prone process steps, and reduces risk of deviations and noncompliance
- Reduced time efforts for drug discovery and development
- Integrates seamlessly with other systems including ERP, Document Management, MES etc.
- The only software system with predefines test modes
- Ensures and maintains continuous quality of the products
- Monitoring of quality-relevant instruments can be demonstrated to auditors during audit trial
- Reduce costs incurred by re-works, scrap, and process down times
- Increase product quality and support efforts to enhance brand equity