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

By Orlando López

ISBN-10: 0203026772

ISBN-13: 9780203026779

ISBN-10: 084932243X

ISBN-13: 9780849322433

Overlaying regulatory specifications stipulated through the FDA, this e-book delineates the association, making plans, verification, and documentation actions and procedural controls required for compliance with world wide desktops validation laws. the writer introduces assisting applied sciences corresponding to encryption and electronic signatures and areas regulatory compliance in the context of caliber insurance. He demonstrates the significance of integrating validation actions into the method lifecycle utilizing a based top-down strategy. He covers sensible functions of caliber insurance and engineering thoughts as they relate to the advance of platforms healthy to fulfill consumer and regulatory necessities.

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

Sample text

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.

If information is not recorded to durable media, the stored data will be lost and cannot be retrieved for future use.  Only regulated electronic records that meet Part 11 can be used to satisfy a predicate rule.  Therefore, one key element to be analyzed by both the FDA and the industry are the regulatory requirements for data that stored in transient memory, including any audit trail information.  Table 3–2 associates the clauses in Subpart B 21 CFR Part 11 with the drugs GMP regulations, applicable FDA CPGs, and the EU GMP regulations.

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.  52631 and 52646. 40(d) provides the regulatory requirements applicable to computer systems: Holding, conveying, and manufacturing systems, including gravimetric, pneumatic, closed, and automated systems, shall be of a design and construction that enables them to be maintained in an appropriate sanitary condition.

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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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