Millipore Technical Publications |
 | AN- AN1075EN00 | |
CCP v5 Software Compliance with FDA Regulation 21 CFR Part 11Electronic batch records in all Millipore’s biopharmaceutical systems. | ||
| Lit No: | AN1075EN00 | |
| Year: | 2002 | |
| The FDA regulation 21 CFR Part 11 concerns pharmaceutical manufacturers because it governs the agency’s acceptance of electronic records as authentic and electronic signatures as legally binding. The scope of the ruling is wide: Part 11 applies to all electronic signatures and records that are submitted to the FDA or in response to FDA requirements, and to all such submissions throughout FDA-regulated industry. Existing pharmaceutical software technology provides for compliant security in verifying electronic signatures and in authenticating and locking electronic records. Millipore’s Common Control Platform version 5 (CCP v5 software), a software system used to control and manage data for chromatography and tangential-flow filtration (TFF) systems, complies with 21 CFR Part 11. Further, CCP v5 software incorporates tools, allowing you to authenticate and lock data in a compliant manner. You can also lock all chromatography and filtration recipes<sup>1</sup>that you create using CCP v5 software and its associated systems. CCP v5 software uses a combination of proprietary routines and third-party authentication systems to provide Part 11-compliant security for electronic signatures and records. Click the PDF above for the full document. NOTE: 1Recipes are also referred to as “recipes” in documents conforming with the nomenclature suggested in “Batch Control Part 1: Models and Terminology”, ANSI/ISA-S88.01-1995. | |
| |
| |
