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ClinTech Research has demonstrated expertise in Computer System Validation, including Validation Testing (IQ, OQ, PQ) and Documentation as per 21 CFR Part 11 compliance guidelines. We have performed implementation in a validated environment for systems like Oracle Clinical, an EDC system, Document Indexing & Tracking system etc.
Validation Documentation
We provide 21 CFR Part 11 compliance validation documentation through our India office, to pharmaceutical and biotechnology companies, as required. Our suite of validation documentation includes:
We provide 21 CFR Part 11 compliance validation documentation through our India office, to pharmaceutical and biotechnology companies, as required. Our suite of validation documentation includes:
- User Requirements Specifications (URS)
- Validation Plan
- Functional Requirements Specifications (FRS)
- System Design Specifications (SDS)
- IQ, OQ, and PQ Plans
- Traceability Matrix
- Validation Summary Report
Computer System Validation Testing (IQ, OQ, PQ)
Working closely with your project team, we can develop software validation test plan for Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) test scripts that addresses user requirements as well as system requirements.
We have demonstrated experience in writing test plans and test scripts for various clinical systems such as Oracle Clinical, CRF Tracking System, EDC etc. Our validation testing services offer through our India office include:
Working closely with your project team, we can develop software validation test plan for Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) test scripts that addresses user requirements as well as system requirements.
We have demonstrated experience in writing test plans and test scripts for various clinical systems such as Oracle Clinical, CRF Tracking System, EDC etc. Our validation testing services offer through our India office include:
- Qualification Plans (IQ, OQ, PQ)
- Test Script Preparation
- Execution & Report Writing
- Validation Testing Summary Report
For more information on any of these services, please
Contact Us.
