21 CFR 11: Complete Guide to International Computer - download pdf or read online

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 overseas laptop validation within the pharmaceutical undefined. The advisor exhibits the best way to conform to desktops validation requisites, whereas highlighting and integrating half eleven requisites into the full laptop 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 dependent top-down procedure is under pressure. details is appropriate to desktops for prescription drugs, cosmetics, nutrients, and clinical machine functions.

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

Example text

Coding) standards, and build Part 11 technical controls into the system Review code integrity using static analysis, audit(s), inspection(s), review(s), and/or walkthrough(s) Conduct software unit testing. , operational checks) are being qualified for new software/hardware •• sequences have been modified •• new operating parameters are being established for existing software/hardware •• existing software/hardware was never qualified In some environments, an OQ is required to test software in testing environment.

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 FDA-Regulated Environment, Journal of cGMP Compliance, July 1997. 11 FDA, Application of the Medical Device GMP to Computerized Devices and Manufacturing Processes, May 1992 12 FDA, General Principles of Software Validation; Final Guidance for Industry and FDA Staff, January 2001.

Multiple versions of the plan and protocols could be needed, with interim or partial reports. The guiding factor for organising validation documentation is the criticality and complexity of the system, and the type of software. Refer to Appendix D. The review and approval of the plan by QA is optional, but will provide an endorsement that the plan conforms to the current written procedures on computer systems validation, and that the document incorporates applicable regulatory requirements. PROJECT SCHEDULE 1.

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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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