Download 21 CFR Part 11: Complete Guide to International Computer by Orlando López PDF

By Orlando López

Overlaying regulatory necessities stipulated by way of the FDA, this e-book delineates the association, making plans, verification, and documentation actions and procedural controls required for compliance with world wide computers validation rules. the writer introduces assisting applied sciences akin to encryption and electronic signatures and areas regulatory compliance in the context of caliber coverage. He demonstrates the significance of integrating validation actions into the method lifecycle utilizing a based top-down strategy. He covers useful purposes of caliber insurance and engineering strategies as they relate to the improvement of platforms healthy to fulfill consumer and regulatory standards.

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Additional info for 21 CFR Part 11: Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry

Example text

The regulatory authority enforcing the GMPs is the FDA. 2(b) emphasized computer backups and documentation, including keeping hardcopy of master formulas, specifications, test records, master production and control records, batch production records (batch production and control records), and calculations. 68 (Automatic, mechanical, and electronic equipment).  3, May/June 2001. Section 510(a) (2)(B) of the Federal Food, Drug, and Cosmetic Act.  190, September 29, 1978. 4 FDA, draft of Guidance for Industry: 21 CFR Part 11; Electronic Records; Electronic Signatures Glossary of Terms, August 2001.

The transition program consists of educating the regulated industry, assessing current computer systems, and implementing the regulations using the appropriate technologies.  Progression of Computer Systems Validation Key Practices6 3 In hybrid systems, some portions of a record are paper and some electronic. 4 López, O, Automated Process Control Systems Verification and Validation, Pharmaceutical Technology, September 1997. López, O, Implementing Software Applications Compliant with 21 CFR Part 11, Pharmaceutical Technology, March 2000.

3, May/June 2001. Section 510(a) (2)(B) of the Federal Food, Drug, and Cosmetic Act.  190, September 29, 1978. 4 FDA, draft of Guidance for Industry: 21 CFR Part 11; Electronic Records; Electronic Signatures Glossary of Terms, August 2001.  It involves establishing that the computer system conforms to the user, regulatory, safety, and intended functional requirements.  In addition to the software and hardware testing, other verification activities include code walkthroughs, dynamic analysis, and trace analysis.

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