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

By Orlando López

Protecting regulatory specifications stipulated by way of the FDA, this ebook delineates the association, making plans, verification, and documentation actions and procedural controls required for compliance with around the world desktops validation rules. the writer introduces aiding applied sciences comparable to encryption and electronic signatures and locations regulatory compliance in the context of caliber coverage. He demonstrates the significance of integrating validation actions into the process lifecycle utilizing a established top-down strategy. He covers sensible functions of caliber coverage and engineering recommendations as they relate to the improvement of structures healthy to fulfill consumer and regulatory standards.

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

Sample text

For custom­built applications, the program listings are considered to be source code; for configurable applications, the configurable elements or scripts are considered to be source code; and for off­the­shelf applications, the critical algorithms, parameters, and macro listings are considered to be source code. , A Guide to Computer Compliance Guides, Journal of cGMP Compliance, January 1997.  The equivalency of an automated single­check system to a manual check must be shown, however, and this might not always be possible.

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.  Refer to Chapter 21.  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.

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.

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