Millipore Technical Publications |
 | TN- TB2134EN00 | |
21CFR Part 11 Compliance Guidelines for Guava® ViaCount® Reagent Assay | ||
| Lit No: | TB2134EN00 | |
| Year: | 2012 | |
| The 21CFR Part 11 regulation applies to records in
electronic form that are created, modified, maintained,
archived, retrieved, or transmitted as per regulations
(predicate rules as GMP, GLP, GCP). It also applies to electronic
records submitted to the FDA (US Food and Drug
Administration), even if not identified in regulations. This
document contains recommendations for providing guidance
to customers to ensure that they meet the procedural
requirements of 21CFR Part 11. Click the PDF above for the full document. | |
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