Why 21 CFR Part 11?
Historically, all the quality documents including SOPs, MPBRs, PBRs and log books have been maintained on paper by companies in order to comply with FDA’s cGMP. Even as companies automated their production and quality processes, they were still being forced to maintain and track paper records. The code of Federal Regulations (CFR) Part 11 was implemented in 1997 to let the FDA accept electronic records and signatures in place of paper records and handwritten signatures for compliance. The regulation outlines controls for ensuring that electronic records and signatures are trustworthy, reliable, and compatible with FDA procedures and as verifiable and traceable as their paper counterparts. Hence, 21 CFR Part 11 also specifies a number of requirements for software systems to enable trustworthy and reliable electronic records and signatures. These software requirements must be met for the resulting electronic records to comply with FDA’s cGMP. If an organization does employ electronic rec
