The FDA established the Electronic Records and Electronic Signatures Rule (21 CFR Part 11) in order to outline the necessities for electronic form records and the accepted electronic signatures ...
On 20 February 2003, the US Food and Drug Administration (FDA) published a new draft guidance relating to 21 CFR Part 11. The new guidance mainly affects the compliance requirements of systems with a ...
Dublin, Dec. 04, 2024 (GLOBE NEWSWIRE) -- The "21 CFR Part 11 Guidance for Electronic Records and Electronic Signatures in FDA-Regulated Industries" webinar has been added to ResearchAndMarkets.com's ...
This 21 CFR Part 11 compliance training will guide you through the requirements of Part 11 and will also explain its 3 primary areas: SOPs, product features and validation (10 step risk based approach ...
REDWOOD CITY, Calif.--(BUSINESS WIRE)-- Box, Inc. (NYSE:BOX), the leading Content Cloud, today announced that its native e-signature product, Box Sign, has achieved support for compliance with FDA 21 ...
In 1997, the US Food and Drug Administration issued a regulation"Rule 21 CFR Part 11," that provides criteria for the acceptance of electronic records, electronic signatures, and handwritten ...
The iQue ® software module for 21 CFR Part 11 ensures next-level iQue ® productivity for regulated laboratories. Designed for speed and actionable results, iQue ® is the instrument of choice for busy ...
IDBS has announced that its complete E-WorkBook Suite has been independently validated by the Sociedad de Validacion de Sistemas (SVS) against the FDA’s 21 CFR Part 11 and Good Laboratory Practice ...
ExpeData, a provider of digital writing solutions for multiple industries including pharmaceuticals and clinical research organizations, is pleased to announce that its EDW digital writing software ...
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