21+CFR+Part+11 category archives

Government Computer News reports that "NARA: New archive system could change records management." NARA has commissioned a new ERA that is to cover all governmental records in all types across all platforms.
Bio-IT World in July 2003 has an article on moving to PDA-based recording, rather than the traditional patient diaries.
This webinar, primarily presented by Ann Rockley (and Arbortext and Documentum). The slides are available (pdf). The goal of the presentation was to provide people with information around developing integrated approaches to records and content management. Records are generally considered to be the documentary evidence of business decisions and business actions....
Mark McClellan, the FDA's new director has released his strategic vision for the agency. FDA: Strategic Plan Advancing America's Health We are moving toward a science-based, "life cycle" approach to assuring the safety of food products. This approach, also based on the principles of efficient risk management, will enable us to...
Piecing Together the Data Picture - Computerworld Data quality translates into companies having the right information at the right time to make decisions. Another article from ComputerWorld that reminds us that if we don't have the infrastructure right, all the data analysis and synthesis in the world isn't going to be...
I was going to complain about how slow the chemical industry has been in reporting significant changes to the FDA interpretation of the 21 CFR Part 11 rules on Electronic Records and Electronic Signatures in FDA-mandated activities. It turns out that there has been relatively little in the mainstream Chem Eng outlets at all.

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