Introduction
Good Practice (GxP) guidelines and 21 CFR Part 11 are critical frameworks that govern pharmaceutical and life sciences manufacturing. Ensuring compliance with these standards demands advanced Supplier Management Software, which brings together process control, documentation, and real-time analytics.
Understanding GxP and 21 CFR Part 11
GxP Explained
- GxP includes GMP (Good Manufacturing Practice), GCP (Good Clinical Practice), and GLP (Good Laboratory Practice). All involve supplier oversight.
21 CFR Part 11
- This regulation focuses on the integrity and security of electronic records and signatures in the pharmaceutical industry.
Supplier Management’s Role in GxP Compliance
Supplier Qualification and Monitoring
- Supplier Management helps assess, score, and qualify suppliers based on risk, performance, and compliance.
Audit Trails
- An audit-ready system automatically captures electronic signatures and logs changes, meeting Part 11 requirements.
Integration with Supplier Relationship Management Software
- Supplier relationship management software securely centralizes and manages critical supplier documents—such as contracts, certifications, and audit records—with robust version control, secure access, and detailed activity logs, ensuring transparency, compliance, and improved supplier collaboration.
Training and Quality Solutions
Supports compliance training and enforces SOP adherence for both internal teams and external partners through comprehensive quality solutions designed to maintain regulatory standards and drive operational excellence.
Why ComplianceQuest is Essential in 2025
ComplianceQuest provides robust Supplier Management Software that is GxP-compliant and fully supports 21 CFR Part 11 mandates. In 2025, it provides pharma and life sciences companies with the agility to adapt quickly to regulatory changes while ensuring the highest levels of data integrity and supplier accountability.
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