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onePager-versiondog GxP-Edition

onePager-versiondog

versiondog FDA & GxP Edition versiondog edition for regulated industries versiondog version with extended functionalities for FDA & GMP regulated industries. • Additional authentication functions • Extended report functions • Admin reporting included What does it do? • Enables to meet the special requirements for FDA & GMP regulated industries • Helps to be compliant with electronic records and signatures (ERES) • Implements two factor-controlled change management • Helps to reduce validation efforts What are the benefits? • Reduces costs for FDA & GMP compliant change management for automation devices • Reduces effort and time needed for Audits • Extended functionalities make complex workflows unnecessary • Self-assessment of versiondog according to GAMP 5 criteria • provides complete evidence of the production configuration in the event of a recall • Extended services for validation and revalidation available • Compliance response for versiondog (Answers the requirements from 21 CFR Part 11 as well as from Annex 11 of the EU GMP Guidelines) Are there any requirements or costs? • Enterprise level at subscription model Where can I find out more? • Website Your Contact Wednesday, January 12, 2022 Dominik Pfundstein Tel: +49 6341 6810 331 E-mail: Dominik.Pfundstein@auvesy.de www.auvesy.com

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