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This webinar explains how to use electronic records and electronic signatures to significantly reduce costs. Learn exactly what is needed to be Part 11 and Annex 11 compliant in all three compliance areas: IT infrastructure SOPs, software product features, and 10-step risk-based validation. You will be able to go paperless, immediately improve productivity, and reduce software implementation costs.
Computer System Validation’s principal, David Nettleton is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, software validation, and computer system validation. He is involved with the development, purchase, installation, operation and maintenance of computerized systems used in FDA compliant applications. He has completed more than 200 mission critical laboratory, clinical, and manufacturing software implementation projects. His latest book is “Risk Based Software Validation - Ten easy Steps” (Davis Horwood International and PDA - www.pda.org) which provides fill-in-the-blank templates for completing a COTS software validation project.
21 CFR Part 11; Compliance with Electronic Records, Signatures, and Validation
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