21 CFR PART 11COMPLIANCE ASSESSMENT - Performance Validation

The 21 CFR Part 11 regulation establishes guidelines for electronic records and signatures, crucial for companies in the life sciences industry. This white paper provides a thorough assessment of the regulation, highlighting the necessary security, traceability, and operational controls for compliance.

Key topics include:

An overview of 21 CFR Part 11 requirements
How ValGenesis VLMS (Validation Lifecycle Management System) meets these standards
Advanced security features such as audit trails, role-based access, and electronic signatures
Ensuring data integrity and compliance through automated workflows and validation

Download the white paper to explore how your organization can maintain compliance and implement a secure, paperless validation system.

This white paper was originally published by ValGenesis and is shared here with permission from Performance Validation.

Brad Henry

Vice President of Services Products - Brad has over 20 years of experience managing and executing CQV projects for the pharmaceutical and medical device industries. He has extensive experience in dry products, parenteral, facilities and utilities, and in-vitro diagnostics.

Schedule with Brad Henry