21 CFR Part 11 Compliance

Octalsoft provide complete enhanced EDC (Electronic Data Solutions)Software . The new features and enhanced capabilities of Octalsoft EDC include integrated dictionary management, real-time patient milestone reporting, and form re-use.

Code of Federal Regulations (CFR)

The Code of Federal Regulations (CFR) is the set of rules published by the federal government to regulate various businesses conducts.  There are 50 sections, known as titles, included in this tome which is reviewed yearly.  Title 21 is the set of rules describing the Food, Drug and Cosmetics Act, and the law enforcement body, the Food and Drug Administration (FDA) that enforces this Act. CFR Title 21 has 1499 parts that deal with every aspect of discovering, preclinical cytotoxicity testing, phase I, phase II, phase II manufacturing, inter-state commerce, etc. food, drugs, biologics, blood, vaccines and cosmetics.

21 CFR Parts 11

Part 11 of the CFR Title 21 code regulates electronic records and electronic signatures. It provides criteria for acceptance by the FDA of electronic records, electronic signatures, and handwritten signatures executed to electronic records as equivalent to paper records and handwritten signatures on paper.  To summarize the rules, if one must maintain records for GMP/GLP, or must submit records to the FDA and would like to do so electronically in place of on paper, then the software used to create the electronic records must be Part 11 compliant.  However, if one uses software but creates paper documentation for GMP/GLP, then the software itself need not be Part 11 compliant for the laboratory to do Part 11 compliant work.