Computerized systems play an important role in the life sciences industry. These systems are used for a wide range of functions, including data collection, processing, analysis, and reporting.
To ensure that these systems are working as intended and in compliance with regulatory requirements, it is essential to validate them. That's where our GxP computerized system validation services come in.
Our GxP Computerized System Validation Services :
CSV Deliverables:
Quality Agreement // Validation Plan // Project Plan // Risk Analysis // BRD: Business Requirements Definition - User Requirements Specifications (URS) // Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) ) // Protocols IQ, OQ, PQ - Test Scripts - Deviations, CAPA - VSR: Validation Summary Reports IQ, IQ, PQ // UAT - PQ: User Acceptance Testing // Validation Traceability Matrix // VMP : Validation Master Plan.
Contact us today to learn more about how we can help you ensure that your computerized systems are compliant and working as intended.
To ensure that these systems are working as intended and in compliance with regulatory requirements, it is essential to validate them. That's where our GxP computerized system validation services come in.
Our GxP Computerized System Validation Services :
- Validation planning
- Risk Assessment
- Validation protocols
- Testing, documentation and reports
- Change control management
- Training and support
CSV Deliverables:
Quality Agreement // Validation Plan // Project Plan // Risk Analysis // BRD: Business Requirements Definition - User Requirements Specifications (URS) // Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) ) // Protocols IQ, OQ, PQ - Test Scripts - Deviations, CAPA - VSR: Validation Summary Reports IQ, IQ, PQ // UAT - PQ: User Acceptance Testing // Validation Traceability Matrix // VMP : Validation Master Plan.
Contact us today to learn more about how we can help you ensure that your computerized systems are compliant and working as intended.