In the highly regulated world of life sciences, ensuring the integrity, reliability, and security of electronic records is not just a best practice—it’s a regulatory requirement. Introduced by the U.S. Food and Drug Administration (FDA), 21 CFR Part 11 sets the standard for electronic records and electronic signatures, aiming to ensure that digital data is trustworthy, traceable, and secure.
As digital systems increasingly replace paper-based processes across laboratories, production environments, and quality systems, understanding and implementing 21 CFR Part 11 has become essential for maintaining compliance and avoiding costly remediation. Read More >
