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

By Orlando López

Protecting regulatory standards stipulated by way of the FDA, this e-book delineates the association, making plans, verification, and documentation actions and procedural controls required for compliance with world wide desktops validation laws. the writer introduces helping applied sciences comparable to encryption and electronic signatures and locations regulatory compliance in the context of caliber insurance. He demonstrates the significance of integrating validation actions into the procedure lifecycle utilizing a established top-down technique. He covers sensible purposes of caliber insurance and engineering ideas as they relate to the improvement of structures healthy to fulfill person and regulatory standards.

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

Example text

If information is not recorded to durable media, the stored data will be lost and cannot be retrieved for future use.  Only regulated electronic records that meet Part 11 can be used to satisfy a predicate rule.  Therefore, one key element to be analyzed by both the FDA and the industry are the regulatory requirements for data that stored in transient memory, including any audit trail information.  Table 3–2 associates the clauses in Subpart B 21 CFR Part 11 with the drugs GMP regulations, applicable FDA CPGs, and the EU GMP regulations.

Detailed description of each activity can be found in other chapter of this book.  Each company should have written and approved validation policies that communicate the expectations of senior management for the execution of a validation project.  To attain this level of compliance, management will ensure that proper validation and qualification will be carried out at all stages of the product development cycle.  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.

For existing computer systems, concurrent validation may be considered where limited documentation on the appropriate technology exists, and where an acceptable level of confidence can be established by reviewing and documenting the operating history.  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. The following describes the process for developing and maintaining computer systems in an FDA context.

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