As regulatory compliance requirements continue to rise for life sciences companies, the need for comprehensive record keeping is becoming more acute. Fortunately, electronic record keeping and management systems can greatly facilitate the speed, accuracy, and ease with which mandated documentation can be kept and retrieved for the FDA and other regulatory agencies.
To address these potential risks, the FDA has worked together with the life sciences industry to devise a policy known as Title 21 CFR Part 11 (Electronic Records/Electronic Signatures).
Title 21 CFR Part 11 establishes criteria by which the FDA will accept electronic records as equivalent to paper records, and electronic signatures as equivalent to traditional handwritten signatures. It is applicable to records required by previously published regulations (predicate rules), as well as new regulations. Predicate rules include Good Laboratory Practice (GLP), Good Clinical Practice (GCP), and Good Manufacturing Practice (GMP).
Part 11 does not mandate that companies to automate their record keeping. Any company that prefers not to automate—or whose electronic documentation systems are not compliant—may continue to use paper records and handwritten signatures. However, organizations that decide to automate their record keeping must ensure that their system adheres to the many regulations in Part 11.
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