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

By Orlando López

This advisor delineates the association, making plans, verification, and documentation actions and procedural controls required for compliance with FDA rules concerning foreign computing device validation within the pharmaceutical undefined. The consultant indicates how one can agree to desktops validation necessities, whereas highlighting and integrating half eleven necessities into the full computing device validation application. Regulatory compliance is positioned in the context of caliber insurance, and the significance of integrating validation into the method lifestyles cycle utilizing a based top-down procedure is under pressure. details is appropriate to computers for prescription drugs, cosmetics, meals, and clinical machine functions.

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Regulatory authorities hold the owner of the records known to be required by existing regulation responsible for assuring the compliance of the computer systems that record and manage such records. 12, ‘Vendor Responsibility’. 30 and all of the CPGs discussed in this chapter. Validation requirements apply to software used as components in medical devices, to software that is itself a medical device, and to software used in production of the device or in implementation of the device manufacturer’s quality system.

For existing computer systems, retrospective evaluation is discouraged. It is extremely difficult to evaluate a computer system retrospectively, being generally more costly and time consuming than prospective validation. Retrospective evaluation should be used only as a corrective measure in response to deficiencies noted concerning prior validation efforts. See Chapter 19 for a brief discussion on this subject. Any deviations raised during the application of a computer system validation procedure shall be documented following the applicable deviation recording procedure.

When developing the validation plan, a decision has to be made about the manner in which the documents will be organised: • For small systems, it is possible to integrate the validation plan and all protocols into one document, and to have one report to summarising all results. • For large systems with many components, a validation project plan can be created that divides the validation effort into smaller, more manageable units with separate plans. • Multiple versions of the plan and protocols could be needed, with interim or partial reports.

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