How Logilab SDMS Helps Laboratories Enable 21 CFR Part 11 Compliance - Part 1

How Logilab SDMS Helps Laboratories Enable 21 CFR Part 11 Compliance - Part 1

Laboratories that generate, process, and manage electronic data must ensure their computerized systems are validated, secure, and capable of preserving data integrity across the entire record lifecycle. Logilab SDMS supports laboratories in adopting a compliant, paperless approach to scientific data management by enabling controlled, reliable, and traceable handling of electronic records in alignment with 21 CFR Part 11 principles.

Inside this white paper, you will learn:

• What 21 CFR Part 11 is and its relevance to laboratory operations
• How the regulation applies to laboratory computerized systems
• The core requirements of 21 CFR Part 11, including validation, audit trails, security controls, and electronic signatures
• How Logilab SDMS establishes a foundation for Part 11 aligned laboratory data management