21 CFR Part 11 Noncompliances (And How to Avoid Them)
Companies subject to 21 CFR Part 11 must adhere to strict requirements for electronic records,...
21 CFR Part 11 Open vs Closed System: What is the Difference?
Life Science companies can use open or closed computer systems for managing electronic records and...
![21 CFR Part 11 Password Requirements [Explained]](svg/21-cfr-part-11-password-requirements.svg)
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21 CFR Part 11 Password Requirements [Explained]
The 21 CFR Part 11 is part of a regulation enforced by the Food and Drug Administration (FDA) that...
![21 CFR Part 11 Audit Trail Requirements [Explained]](svg/fda-21-cfr-part-11-audit-trail-illustration.svg)
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21 CFR Part 11 Audit Trail Requirements [Explained]
The 21 CFR Part 11 is a part of the regulation by the US FDA that establishes the criteria for...
21 CFR Part 11 Compliant Electronic Signatures (Guide)
21 CFR Part 11 compliant electronic signatures refer to digital signatures that meet the Food and...
21 CFR Part 11 Compliance: Everything You Need to Know
The 21 CFR Part 11 is a Food and Drug Administration (FDA) regulation specifying the requirements...
Medical Device Quality Management System (QMS)
A Medical Device Quality Management System (QMS) is a set of policies, processes, and procedures...
Pharmaceutical Quality Management System (QMS)
Pharmaceutical Quality Management System (QMS) is a set of procedures and practices contributing...
Effective Quality Management System (and How to Measure It)
An effective quality management system (QMS) is a system that enables a company to consistently...
Life Science QMS (The Essential Guide)
For all industries, a Quality Management System (QMS) is essential to formalize the processes,...