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

By Orlando López

ISBN-10: 084932243X

ISBN-13: 9780849322433

This consultant delineates the association, making plans, verification, and documentation actions and procedural controls required for compliance with FDA laws concerning foreign computing device validation within the pharmaceutical undefined. The consultant exhibits the best way to conform to desktops validation necessities, whereas highlighting and integrating half eleven specifications into the total machine validation application. Regulatory compliance is put in the context of caliber coverage, and the significance of integrating validation into the procedure lifestyles cycle utilizing a established top-down strategy is under pressure. details is acceptable to desktops for prescription drugs, cosmetics, meals, and scientific machine functions.

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

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These assessments must be performed in order to identify any functional gaps, and/ or procedural gaps, which may be present for each computer system implemented. The analysis will determine if operational, maintenance or security controls, specific to the system, provide a controlled environment ensuring the integrity of the electronic records and/or signatures as stated in the regulatory requirements. Additional information can be found in Chapter 19. VALIDATION OF COMPUTER SYSTEMS Refer to Chapter 2.

Many of the custom-built programs can be found, for example, in PLC. For configurable applications, the source code is the proprietary information of the developer, so the likelihood of acquiring the source code is very low. l5, ‘Source Code for Process Control Application Programs,’ and include consideration of the source code as master production and control records. Accordingly, those sections in the regulations relevant to master production and control records are applied to the computer application as source code.

101(d) requires verification by a second person for components added to a batch. A single automated check is acceptable if it provides at least the same assurance of freedom from errors as a double check. If it does provide the same assurance, the process does not gain by applying a redundant second check, which adds nothing to the assurance of product quality. The equivalency of an automated single-check system to a manual check must be shown, however, and this might not always be possible. A major compliance issue is the administration of electronic records.

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21 CFR 11: Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry by Orlando López


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