New PDF release: 21 CFR Part 11: Complete Guide to International Computer

By Orlando López

ISBN-10: 0203026772

ISBN-13: 9780203026779

ISBN-10: 084932243X

ISBN-13: 9780849322433

Masking regulatory requisites stipulated by way of the FDA, this booklet delineates the association, making plans, verification, and documentation actions and procedural controls required for compliance with around the world computers validation laws. the writer introduces helping 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 method. He covers functional functions of caliber insurance and engineering innovations as they relate to the advance of structures healthy to fulfill person and regulatory specifications.

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

Sample text

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.  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.

Chapter 18 provides information on ongoing support systems.  It is the responsibility of Executive Management to provide adequate resources to support the achievement of compliance in the computer systems validation area. Responsibilities are often similar across multiple functional groups such as Information Technology, Engineering, Laboratories (QA/R&D), Clinical Research, Manufacturing/ Operations, contract developers, and computer technology suppliers.  This chapter suggests an organizational structure for supporting to a computer validation program.

Each company should have written and approved validation policies that communicate the expectations of senior management for the execution of a validation project.  To attain this level of compliance, management will ensure that proper validation and qualification will be carried out at all stages of the product development cycle.  Concurrent validation will be employed where applicable, to certify that an appropriate level of process control exists for all pertinent products, equipment, facilities and systems.

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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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