Computer System Validation (CSV)
Ensuring compliance and reliability of computerized systems in regulated environments.
Computer System Validation (CSV)
Our CSV services ensure that your systems meet the highest standards of regulatory
compliance.
Software Development Life Cycle (SDLC):
- User Requirement Specifications (URS)
- Functional Specifications (FS)
- Design Document Specifications (DDS)
- Hardware Design Specifications (HDS)
- Design Qualification (DQ)
Testing and Validation:
- Module Testing
- Integration Testing
- Factory Acceptance Testing (FAT)
- Installation Qualification (IQ)
- Operational Qualification (OQ)
Best Practices:
- Ensuring all systems and software align with international standards and regulatory requirements.
- Boundary Identification: Identifying and developing system boundaries for
targeted testing. - Stagewise and Progressive Testing: Implementing testing methodologies for
efficient validation. - Leveraging Testing: Maximizing the effectiveness of testing activities.
Regulatory Compliance:
- Ensuring compliance with US FDA 21 CFR Part 11 and EU Annex 11.
- Applying principles from the ISPE GAMP 5 guide for comprehensive validation.
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