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

By Orlando López

ISBN-10: 0203026772

ISBN-13: 9780203026779

ISBN-10: 084932243X

ISBN-13: 9780849322433

Overlaying regulatory standards stipulated via the FDA, this booklet delineates the association, making plans, verification, and documentation actions and procedural controls required for compliance with all over the world computers validation laws. the writer introduces aiding 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 approach lifecycle utilizing a dependent top-down process. He covers useful functions of caliber coverage and engineering recommendations as they relate to the improvement of structures healthy to satisfy consumer and regulatory standards.

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

Example text

Chapter 14 covers this subject. 12, ‘Vendor Responsibility’. 30 and all of the CPGs discussed in this chapter.  An evaluation of component suppliers and qualification of device manufacturing line(s) are elements of this qualification.  52631 and 52646.  The application of this section to product software10 includes all design activities necessary to obtain, review, implement, and validate a design specification. ’11 The most recent FDA validation guidance,12 which is exclusively applicable to medical devices, provides comprehensive information on the implementation of applicable software validation regulations to medical device computer systems performing regulated operations.

As the one described in GAMP)1 and the complexity and criticality of the system.  A sample Criticality and Complexity Assessment can be found in Appendix D.  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.  It is the practice in the FDA­ regulated industry to take into account five (5) categories of software. 0, ISPE (GAMP Forum), December 2001.  Conventional Waterfall Model.

For the current generation of systems, an assessment will have to performed to evaluate the level of conformity with the regulation. Examples of the applicability of this model can be found in Appendix C.  It is the project manager’s responsibility to take into account the technological requirements, standards, procedural controls, regulatory requirements and related guidelines, and industry standards.  Figure 5–1 suggests a computer validation management cycle.  Computer Validation Management Cycle.

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


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