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

By Orlando López

ISBN-10: 084932243X

ISBN-13: 9780849322433

This advisor delineates the association, making plans, verification, and documentation actions and procedural controls required for compliance with FDA rules relating to overseas laptop validation within the pharmaceutical undefined. The consultant exhibits find out how to conform to computers validation specifications, whereas highlighting and integrating half eleven specifications into the total computing device validation application. Regulatory compliance is put in the context of caliber insurance, and the significance of integrating validation into the procedure lifestyles cycle utilizing a established top-down procedure is under pressure. info is acceptable to computers for prescribed drugs, cosmetics, foodstuff, and scientific equipment purposes.

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

Sample text

The objective of this review is to verify that the all of the specifications are correct, consistent, complete, unambiguous, testable, modifiable, and traceable to the concept phase documentation Perform and document a traceability analysis between the requirements specification deliverable and system specification deliverable Specify Part 11 technical controls Prepare and approve system specification deliverable Revisit the risk analysis and the criticality and complexity assessments based on the system specification deliverable Review validation plan based on the system specification deliverable Approved validation plan Begin to plan the test activities, including unit testing, integration testing, factory acceptance testing, site acceptance testing, and system qualifications – Technical design System requirements are applied to the software design.

The foundations of these key practices are contained on publications such as: • Guideline on General Principles of Process Validation, May 1978 • Compliance Policy Guidelines, September 1982 • Guide to Inspection of Computerized Systems in Drug Processing, February 1983 • PMA Staying Current Series (series started in May 1986) • Application of the Medical Device GMPs to Computerized Devices and Manufacturing Processes, November 1990 • Good Automated Manufacturing Practices (GAMP), February 1994 • PDA’s Validation of Computer Related Systems, October 1994 • General Principles of Software Validation; Final Guidance for Industry and FDA Staff, June 2001 • PDA’s A Globally Harmonized Glossary of Terms for Communicating Computer Validation Key Practices, PDA Journal of Pharmaceutical Science and Technology, Vol.

Sidebar 5–1. Sample Policy. Policies are intended to establish responsibilities and expectations. All computer systems validation procedures, guidelines, and strategies must be consistent with the Validation Policy. An example of a corporate-wide validation policy is contained in Sidebar 5–1. In the context of Part 11, it is expected that information shall be characterized and information quality incorporated into the computer systems development and operational life periods. 1 PDA Committee on Validation of Computer-Related Systems, Technical Report No.

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