Q&A on cGMP Good Guidance Practices – Records and Reports
$0.00
The FDA publishes Questions and Answers on Current Good Manufacturing Practices, Good Guidance Practices, Level 2 Guidance – Records and Reports on www.FDA.gov.
In this copy of the FDA’s web publication, in response #3, the FDA answers the question: How do the Part 11 regulations and “predicate rule requirements” in 21 CFR 211 apply to electronic records created by computerized laboratory systems and the associated printed chromatograms that are used in drug manufacturing and testing.
You may also like…
-
FDA 21 CFR 11: Electronic Records; Electronic Signatures, 3/97
The FDA regulation on electronic records and electronic signatures.
$0.00 Add to cart -
FDA 21 CFR 211: cGMP for Finished Pharmaceuticals
FDA federal regulation for the manufacturing of finished pharmaceutical drug products.ﾠ
$0.00 Add to cart -
FDA Guidance: Part 11, Electronic Records; Electronic Signatures – Scope and Application, 8/03
August, 2003 guidance on 21 CFR Part 11 scope of application, enforcement focus areas, and a risk based compliance approach.
$0.00 Add to cart
