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

By Orlando López

Protecting regulatory requisites stipulated via the FDA, this publication delineates the association, making plans, verification, and documentation actions and procedural controls required for compliance with around the globe computers validation laws. the writer introduces assisting applied sciences resembling encryption and electronic signatures and locations regulatory compliance in the context of caliber coverage. He demonstrates the significance of integrating validation actions into the method lifecycle utilizing a dependent top-down strategy. He covers useful functions of caliber coverage and engineering concepts as they relate to the advance of structures healthy to fulfill person and regulatory standards.

Show description

Read Online or Download 21 CFR Part 11: Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry PDF

Similar international_1 books

Distributed, Parallel and Biologically Inspired Systems: 7th IFIP TC 10 Working Conference, DIPES 2010 and 3rd IFIP TC 10 International Conference, BICC 2010, Held as Part of WCC 2010, Brisbane, Australia, September 20-23, 2010. Proceedings

St This quantity comprises the complaints of 2 meetings held as a part of the 21 IFIP international computing device Congress in Brisbane, Australia, 20–23 September 2010. th the 1st a part of the booklet offers the lawsuits of DIPES 2010, the 7 IFIP convention on dispensed and Parallel Embedded structures. The convention, int- duced in a separate preface through the Chairs, covers a number of issues from specification and layout of embedded platforms via to dependability and fault tolerance.

Neural Information Processing: 23rd International Conference, ICONIP 2016, Kyoto, Japan, October 16–21, 2016, Proceedings, Part I

The 4 quantity set LNCS 9947, LNCS 9948, LNCS 9949, and LNCS 9950 constitutes the lawsuits of the twenty third foreign convention on Neural details Processing, ICONIP 2016, held in Kyoto, Japan, in October 2016. The 296 complete papers offered have been conscientiously reviewed and chosen from 431 submissions.

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

Example text

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.  Sufficiently detailed past processing and control records must be available for retrospective validation studies to be considered.  Sample Policy.  All computer systems validation procedures, guidelines, and strategies must be consistent with the Validation Policy. An example of a corporate­wide validation policy is contained in Sidebar 5–1.

Examples of the applicability of this model can be found in Appendix C.  It is the project manager’s responsibility to take into account the technological requirements, standards, procedural controls, regulatory requirements and related guidelines, and industry standards.  Figure 5–1 suggests a computer validation management cycle.  Computer Validation Management Cycle.  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.

12, ‘Vendor Responsibility’ and Part 11 has now established the detailed requirements for such records.  Equivalent sections can be found in the other FDA regulations.  US Drugs GMP. 11, Computerized Drug Processing, CGMP Applicability to Hardware and Software, 9/4/87.  87, May 3, 1996.  Reconciliation GMPs, EU Annex 11 and Part 11.  88–94. * Proposed changes to CGMP, May 1996. 68(b) requires appropriate controls over computer or related systems to ensure that only authorized personnel make changes in master production and control records or other records.

Download PDF sample

Rated 4.50 of 5 – based on 26 votes