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Baxter Healthcare, 6/10
Date Published:
Thu, 06/03/2010
Warning Letter noting CAPA failure involving software as the root cause.
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Poll
Per the draft FDA Guidance on home-use medical devices, where should developers look for more information on software topics?:
FDA Glossary of Computerized System and Software Development Terminology
FDA Guidance, General Principles of Software Validation
FDA Regulation 21 CFR 11, Electronic Record: Electronic Signatures
FDA Regulation 21 CFR 820, Quality System Regulation
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