Electronic Record Keeping: Achieving and Maintaining Compliance with 21 Cfr Part 11 and 45 Cfr Parts 160, 162, and 164

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The current revolution in software, and the regulations that have evolved to address it, have increasingly caused companies to turn to off-the-shelf software for electronic record keeping. Data captured in computerized systems must be as reliable, if not more so, than data on paper. Electronic Record Keeping: Achieving Compliance with 21 CFR Part 11 and 45 CFR Parts 160, 162, and 164 explores how to evaluate, select, implement, and document an e-system that will keep your organization in compliance. Covering Title 21 of ...

Electronic Record Keeping: Achieving and Maintaining Compliance with 21 Cfr Part 11 and 45 Cfr Parts 160, 162, and 164 2003, CRC Press, Boca Raton, FL

ISBN-13: 9780849321641

Hardcover

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