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

By Orlando López

This consultant delineates the association, making plans, verification, and documentation actions and procedural controls required for compliance with FDA laws on the topic of foreign desktop validation within the pharmaceutical undefined. The advisor exhibits how one can agree to computers validation requisites, whereas highlighting and integrating half eleven specifications into the full laptop validation application. Regulatory compliance is put in the context of caliber insurance, and the significance of integrating validation into the method lifestyles cycle utilizing a based top-down strategy is under pressure. info is appropriate to desktops for prescribed drugs, cosmetics, meals, and scientific equipment purposes.

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Responsibilities are often similar across multiple functional groups such as Information Technology, Engineering, Laboratories (QA/R&D), Clinical Research, Manufacturing/ Operations, contract developers, and computer technology suppliers. 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.

Refer to Appendix E. –Conduct a PQ – Develop qualification report(s) and/or a validation report Test results and data are formally evaluated – Conduct a Process/Product PQ. Note: typically, this activity is performed on manufacturing systems only. The objective is to demonstrate that the process consistently produces a result or product meeting predetermined specifications Prepare and approve a Product/Process Summary Report Update any documentation that has references to the application software and its associated version The approved summary report and associated validation documentation are submitted for retention to the National Quality Assurance Document Control Center or site documentation retention center • 3rd, 4th, and 5th Periods—Early Operational Life, Maturity, and Aging – hardware and software operation and maintenance – ongoing reviews/verification program • 6th Period—Retirement – elimination or replacement of computer systems SYSTEM DEVELOPMENT FILES One key element necessary to support the SLC is the availability and maintenance of the system development files.

To reduce duplication, each system development file should avoid containing information provided in other documents, or in other system development files. The set of system development files should include (directly or by reference) the following information: • design considerations and constraints • design documentation and data • schedule and status information • test requirements and responsibilities • verification and test procedures, and results Chapter 8 Validation Project Plans and Schedules REGULATORY GUIDANCE The validation plan is a strategic document that should state what is to be done, the scope of approach, the schedule of validation activities, and tasks to be performed.

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