Orlando López's 21 CFR 11: Complete Guide to International Computer PDF

By Orlando López

ISBN-10: 084932243X

ISBN-13: 9780849322433

This advisor delineates the association, making plans, verification, and documentation actions and procedural controls required for compliance with FDA rules with regards to overseas laptop validation within the pharmaceutical undefined. The advisor indicates the right way to agree to desktops validation specifications, whereas highlighting and integrating half eleven standards into the whole desktop validation application. Regulatory compliance is positioned in the context of caliber coverage, and the significance of integrating validation into the approach lifestyles cycle utilizing a established top-down technique is under pressure. info is acceptable to computers for prescribed drugs, cosmetics, nutrition, and scientific gadget purposes.

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

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Audit mechanism b. Metadata c. Display and reporting 5. Electronic signatures a. E-sign without biometric/behavioral identification b. E-sign with biometric/ behavioral identification c. Signature manifestation d. Signature purpose e. Signature binding 6. 4,5 3 In hybrid systems, some portions of a record are paper and some electronic. López, O, Automated Process Control Systems Verification and Validation, Pharmaceutical Technology, September 1997. 5 López, O, Implementing Software Applications Compliant with 21 CFR Part 11, Pharmaceutical Technology, March 2000.

12, ‘Vendor Responsibility’ and Part 11 has now established the detailed requirements for such records. In 1983, the FDA provided another important guideline applicable to computer hardware and software performing functions covered by the regulations. Their ‘Guide to Inspection of Computerized Systems in Drug Processing’ addresses the applicability of the regulations to computer systems. According to this guideline, computer systems hardware and software are considered equipment and records, respectively, within the context of the regulations.

In order to manage the execution and supervision of computer systems validation activities, there needs to be an organizational structure established. This chapter suggests an organizational structure for supporting to a computer validation program. ORGANIZATIONAL MODEL This model (Figure 6–1) is an example of how computer systems validation and its related activities can be organized and responsibilities allocated. Each organization should prepare a document to identify the roles and responsibilities appropriate for its business environment.

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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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