Download 21 CFR Part 11: Complete Guide to International Computer by Orlando López PDF
By Orlando López
Masking regulatory requisites stipulated by way of the FDA, this ebook delineates the association, making plans, verification, and documentation actions and procedural controls required for compliance with all over the world computers validation rules. the writer introduces assisting applied sciences comparable to encryption and electronic signatures and locations regulatory compliance in the context of caliber insurance. He demonstrates the significance of integrating validation actions into the procedure lifecycle utilizing a established top-down technique. He covers functional functions of caliber insurance and engineering innovations as they relate to the advance of platforms healthy to satisfy person 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
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.
However, organizations performing regulated operations must be aware of these differences in terminology as they ask for and provide information regarding computer systems. Refer to Appendix E. The developer must document the development of each system unit, system component, and configuration item in the software development files and/or use a suitable configuration management tool. The set of system development files should include (directly or by reference) the following information: Page 41 • design considerations and constraints • design documentation and data • schedule and status information • test requirements and responsibilities • verification and test procedures, and results Page 42 This page intentionally left blank.
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. López, Applying Design Controls to Software in the FDARegulated Environment, Journal of cGMP Compliance, July 1997. FDA, Application of the Medical Device GMP to Computerized Devices and Manufacturing Processes, May 1992 11 12 FDA, General Principles of Software Validation; Final Guidance for Industry and FDA Staff, January 2001.