- Validation Master Plans
- User Requirements
- Functional Specifications
- Design Documents
- Factory Acceptance Tests
- Impact Assessments
- Installation Qualifications
- Operational Qualifications
- Controls / Automation Qualifications
- Computer Systems Validation
- Performance Qualifications
- Disaster Recovery Procedures
- SOP Development
validation refers to establishing documented evidence that a process or system, when operated within established parameters, can perform effectively and reproducibly to produce a medicinal product meeting its pre-determined specifications and quality attributes
Wednesday, December 23, 2009
Document creation and execution
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Pharmaceutical Validation Documentation Requirements
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