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

By Orlando López

This consultant delineates the association, making plans, verification, and documentation actions and procedural controls required for compliance with FDA rules relating to foreign computing device validation within the pharmaceutical undefined. The advisor indicates the way to agree to computers validation requisites, whereas highlighting and integrating half eleven specifications into the complete desktop validation software. Regulatory compliance is positioned in the context of caliber coverage, and the significance of integrating validation into the method lifestyles cycle utilizing a established top-down process is under pressure. info is appropriate to desktops for prescription drugs, cosmetics, foodstuff, and scientific gadget purposes.

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

Sample text

Company name is committed to ensuring that the products, equipment, facilities, computerized systems, and support systems directly involved in the manufacture, testing, control, packaging, holding and distribution of marketed products are compliant with cGMP regulations. This commitment extends to the manufacturing, facilities, utilities, processing, cleaning, computerized systems, analytical and microbiological methods, packaging and support systems involved in the development and production of pharmaceutical products subject to cGMP regulations.

The level, frequency, and extent of the I/O checking was suggested in the Federal Register of January 20, 1995 (60 FR 4091). The level and frequency of the I/O verifications must be guided by written procedure, and based on the complexity and reliability of the computer system. 85 is considered an Advisory Opinion directed to FDA inspectors. These guidelines are the mechanisms utilized by the FDA to spread policy statements within the Agency and to the public. Another topic relevant to computer systems in GMP environments is the management of application source code.

11, Table 3–1 lists the primary sections in the regulations applicable to computer systems performing functions covered by the GMPs. Equivalent sections can be found in the other FDA regulations. 11, Computerized Drug Processing, CGMP Applicability to Hardware and Software, 9/4/87. 21 CFR Part 11 18 Table 3–1. US Drugs GMP. 220(a)7 7 Responsibilities of QC Unit Personnel qualifications Design and construction Equipment design, size, and location Cleaning and maintenance Maintenance and calibration Written procedures Record controls Validation of computer systems (implicit requirement) Written procedures, deviations Double check on computer Equipment identification General (records and reports) Records retention Storage and record access Records medium Use of log(s) Reproduction accuracy Documentation and operational checks Records review QC record review Validation of computer systems (explicit requirement) 1996 CGMP proposed regulations, FR, Vol.

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