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 laws regarding overseas desktop validation within the pharmaceutical undefined. The advisor indicates the right way to conform to computers validation specifications, whereas highlighting and integrating half eleven specifications into the complete desktop validation software. Regulatory compliance is positioned in the context of caliber insurance, and the significance of integrating validation into the approach lifestyles cycle utilizing a based top-down procedure is under pressure. details is appropriate to computers for prescribed drugs, cosmetics, foodstuff, and scientific machine purposes.

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

Sample text

Any new equipment, process, product, facility or system will be prospectively validated prior to becoming operational in the manufacture of finished dosage forms. Concurrent validation and qualification will be considered for any existing equipment, facility, product or system where limited documentation of appropriate technology background exists, and an acceptable level of confidence can be established by reviewing and documenting the operating history. Concurrent validation will be employed where applicable, to certify that an appropriate level of process control exists for all pertinent products, equipment, facilities and systems.

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.

Automated process control systems) Chapter 10 provides a comprehensive description of the validation elements to be considered for each software category. Figure 2–3 illustrates a typical SLC. Using as an example, a high-criticality and highcomplexity, custom-built system, the conventional ‘V’ model (Figure 7–1) as framework, and the typical waterfall methodology as development methodology, the following sections summarize the typical project activities. Detailed descriptions by SLC Periods can be found in Appendix E.

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