FDA's regulation 21 CFR Part 11 on Electronic Records and Electronic Signatures provides industry with the requirements that allow electronic records and signatures in computerized systems in place of paper records and handwritten signatures.1
Karin Östergren, M.Sc.
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Karin Ãstergren, M.Sc., is the manager for Quality Assurance Computerized Systems, AstraZeneca Sweden Operations, S-151 85 Södertälje, Sweden.
Articles by Karin Östergren, M.Sc.
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Upgrading a Pharmaceutical Laboratory to Part 11 CompliancePublished: May 1st 2004 | Updated:
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