Computer Systems Validation and Part 11.

[@hardstylebasstard1500]

Oops, long time ago ... but ... good questions and great answers. Still very helpful.

[@mosfetking4709]

Is gmp dar es electrónica récord has to be backup ???

[@DA-mb6dv]

Which section of CFR11 or regulatory guideline says we can not have hybrid records means half electronic and half paper record.

[@genaumoreasmore4581]

Dear Dilip Avhad Many thanks for your comment. Actually, paper and electronic record and signature components can co-exist (i.e., a hybrid situation) as long as predicate rule requirements are met and the content and meaning of those records are preserved (FDA Part 11 Guidance (§ 11.10 (c)) August 2003). Increased data review is likely to be required for hybrid systems because they are vulnerable to non-attributable data changes (MHRA GXP Data Integrity Guidance and Definitions March 2018). Kind regards Henrik Johanning, Genau & More A/S

[@Life_is_beautiful333]

This Is amazing discussion that i heard thanku