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Description of the Checklists - Computer system validation and maintenance checklist
This checklist will enable you to systematically assess the strengths and weaknesses of a computerised system validation using a uniform approach. A scoring option is included which enables you to compare different systems and helps you to judge the compliance status of these systems. The checklist, which contains more than 80 questions, can be used to evaluate potential validation contract vendors/suppliers (front cover letter included). This checklist was created in line with regulatory requirements such as FDA 21 CFR Part 211.68 Automatic, mechanical and electronic equipment, modified FDA 21 CFR Part 11 Electronic records and electronic signatures, FDA Guidance for industry: Computerised systems used in clinical trails, European Guide to Good Manufacturing Practice (1992) Annex 11 Computerized Systems, PIC PH 1/97 Guide to Good Manufacturing Practice for Medicinal Products (Feb. 1997) Annex 5 Computerised Systems, the Blue Book (FDA), PIC/S Guide to Inspection of Computerised Systems, the APV Guide to Annex 11 (EU), GAMP Guide to Validation (EU and FDA) and PDA Technical Report 18 (FDA).
Table of Contents:
1. Computerized System Validation (CSV) Master Plan
2. CSV SOPs integrity
3. User Requirement Specifications (URS)
4. System Risk Assessment
5. Vendor Assessment
6. Validation Protocol in general
7. Test Plans in general
7.1. Test plan approval
7.2. References to specifications
7.5. IQ test plans and reports
7.6. OQ test plans and reports
7.7. PQ test plans and reports
8. Validation report
9. SOPs and Procedures
9.1. System management
9.2. Configuration management
9.3. Security Management Procedure
9.4. Back-up procedures
9.5. Change control
9.6. Maintenance und problem
9.7. Operating Instructions
10. Response Approval
Computer system validation and maintenance checklist
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