Download e-book for iPad: 21 CFR 11: Complete Guide to International Computer by Orlando López

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 desktop validation within the pharmaceutical undefined. The advisor indicates tips on how to conform to desktops validation specifications, whereas highlighting and integrating half eleven requisites into the complete desktop validation software. Regulatory compliance is positioned in the context of caliber insurance, and the significance of integrating validation into the method lifestyles cycle utilizing a established top-down method is under pressure. details is acceptable to computers for prescribed drugs, cosmetics, meals, and clinical equipment functions.

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

Example text

10(a), and defined in the recent draft FDA guideline,4 is one of the most important requirements applicable to computer systems performing regulated operations. Computer systems validation is the confirmation (by examination and the provision of objective evidence) that computer system specifications conform to user needs and intended uses, and that all requirements can be consistently fulfilled. It involves establishing that the computer system conforms to the user, regulatory, safety, and intended functional requirements.

Each phase of the SLC must be controlled to maximize the probability that a finished system meets all quality, regulatory, safety, and specification requirements. If an SLC approach is applied properly, no additional work will be required to validate a system. For each SLC period and event, computer systems validation requires that the development processes are documented work products. As explained in Chapter 2, phase gate verification activities performed during each event may be a perfect place to review and quantify the quality of all products needed to support the next phase.

3, May/June 2001. 2 Grigonis, Subak, and Wyrick, Validation Key Practices for Computer Systems Used in Regulated Operations, Pharmaceutical Technology, June 1997. New computer systems validation model 25 Figure 4–1. 21 CFR Part 11 Model. • whether the computer system is closed or open • whether the system creates electronic records • whether the system uses electronic signatures In general, the elements to be verified and/or qualified during software implementation are • the type of system (open or closed) • security functions • audit trails • operations controlled by the computer systems (operational checks) • implementation of the technology to support the process and Part 11 21 CFR Part 11 26 These two latter elements are not identical on all systems.

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21 CFR 11: Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry by Orlando López


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