Ensure 21 CFR Part 11 Compliance with Confidence

Pharmaceutical and biotech labs operating under FDA and EU GMP requirements must meet stringent standards for electronic records and electronic signatures. This white paper from Sartorius offers a comprehensive checklist for evaluating your system’s compliance with 21 CFR Part 11—and introduces how the Sterisart® Universal | Gen 4 – Advanced simplifies compliance without compromising productivity.

What You’ll Learn:

·       Key criteria for 21 CFR Part 11 compliance, including:

o   Electronic signatures and user authentication

o   Secure audit trails and access controls

o   Electronic record retention and traceability

• How the Sterisart® Universal Pump | Gen 4 supports digital compliance
• Built-in tools for data integrity, documentation, and SOP creation
• Guidance on customer actions to maintain compliance

Who Should Download This White Paper:

·       Quality Assurance Managers – Ensure your sterility testing processes align with 21 CFR Part 11 and data integrity requirements.

·       Regulatory Affairs Professionals – Gain clarity on how the Sterisart® Universal | Gen 4 supports compliance with FDA and EU GMP Annex 11 guidelines.

·       Microbiology and Sterility Testing Lab Managers – Learn how to streamline documentation, manage audit trails, and simplify SOP adherence.

·       Pharmaceutical and Biotech Manufacturing Leads – Evaluate tools that enhance data security, traceability, and regulatory readiness across production environments.

·       Procurement and Lab Operations Teams – Discover the compliance benefits of upgrading to a digitally integrated, future-proof sterility testing platform.

This white paper is essential reading for any stakeholder involved in sterile product testing, regulatory compliance, or digital transformation initiatives in life sciences labs.