![]() It contains new information on outsourcing, electronic batch recording, end user applications (such as spreadsheets and small database applications), and patch management.Īn exciting new innovation is the CD accompanying the softcover Guide. ![]() This revolutionary Guide addresses the entire lifecycle of an automated system and its applicability to a wide range of information systems, lab equipment, integrated manufacturing systems, and IT infrastructures. It points to the future of computer systems compliance by centering on principles behind major industry developments such as PQLI ICH Q8, Q9, Q10 and ASTM E2500. This technical document describes a flexible risk-based approach to compliant GxP regulated computerized systems, based on scalable specification and verification. GAMP® 5 provides pragmatic and practical industry guidance to achieve compliant computerized systems fit for intended use in an efficient and effective manner. A version of this publication in German is also available. Please note: This is the English version of GAMP 5. ![]()
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |