Get 21 CFR Part 11: Complete Guide to International Computer PDF

By Orlando López

ISBN-10: 0203026772

ISBN-13: 9780203026779

ISBN-10: 084932243X

ISBN-13: 9780849322433

Overlaying regulatory standards 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 desktops validation rules. the writer introduces assisting applied sciences similar to encryption and electronic signatures and areas regulatory compliance in the context of caliber insurance. He demonstrates the significance of integrating validation actions into the method lifecycle utilizing a established top-down method. He covers sensible purposes of caliber coverage and engineering suggestions 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

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. 68.  If information is not recorded to durable media, the stored data will be lost and cannot be retrieved for future use.

0, ISPE (GAMP Forum), December 2001.  Conventional Waterfall Model. K. , automated process control systems) Chapter 10 provides a comprehensive description of the validation elements to be considered for each software category.  Using as an example, a high­criticality and highcomplexity, custom­built 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.

Using as an example, a high­criticality and highcomplexity, custom­built 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.  Part 11 considerations are a key element in this phase, which includes the following activities. – Initialization of the project to automate or to re­engineer an operation Review project proposal Develop operation study Perform preliminary evaluation of the technology available Refine scope of the system and confirm strategic objectives Develop a process/operating description, associated restrictions, interfaces, proposed solution, and critical operational checks/sequencing, including how Part 11 will affect and interact with the process/operation Approve the operational feasibility study Perform a preliminary Criticality and Complexity analysis – Business and regulatory decision to continue or to hold the project Appendix E contains a comprehensive description of the Conceptualization Period.

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21 CFR Part 11: Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry by Orlando López


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