Computer System Validation (CSV)
Computer System Validation (CSV) is essential for ensuring that all computer systems and software impacting product quality are properly validated and comply with regulatory requirements. Whether dealing with large-scale process controls or simple embedded code in regulated devices, pharmaceutical and medical device manufacturers must validate their GxP-critical systems to ensure their reliability and accuracy. This validation process includes evaluating the risks associated with computer systems and ensuring they meet stringent guidelines for product quality and safety.
The scope of our Computer System Validation services encompasses a wide range of systems including PLC-based control systems with HMI/MMI user interfaces, camera systems, SCADA systems, micro-controller-based control systems, and the operating software for SCADA systems. We also provide equipment validation services for devices such as incubators and stability chambers. Our services are designed to meet the highest standards of quality and compliance, ensuring that all systems function correctly and reliably in regulated environments.
Our Computer System Validation services deliver a comprehensive set of documentation and reports, including Qualification Documentation (GxP, RA, GAP, CSV, IQ, OQ, PQ, VSR), Re-Qualification Documentation (RA, Requalification Protocol, IQ, OQ, PQ), and Re-Validation Documentation (Performance Verification Protocol, IQ, OQ). The workflow involves developing a Master Validation Plan, listing PLC/SCADA/control systems, collecting raw data, conducting GxP, risk, and gap assessments, and generating and executing protocols. We ensure all reports are compiled, acceptance criteria are met, and any deficiencies are addressed through corrective and preventive actions, culminating in a final submission of all reports.
Scope of Work
- PLC-based Control Systems
- PLC-based Control Systems with HMI/MMI User Interface
- PLC-based Control Systems with SCADA
- Micro-Controller Based Control Systems
- Operating Software for SCADA
- Equipment Validation (e.g., Incubators, Stability Chambers)
CSV Services Deliverables
- Qualification Documentation: GxP, RA, GAP, CSV, IQ, OQ, PQ (if required), VSR, Test Cases (if required)
- Re-Qualification Documentation: RA, Requalification Protocol (including IQ, OQ, PQ), Test Cases (if required)
- Re-Validation Documentation: Performance Verification Protocol (including IQ, OQ), Test Cases (if required)
- Master Validation Plan
- List of PLC/SCADA/Control Systems
- Collection of Raw Data and Reference Documents
- GxP Assessment
- Risk Assessment
- Gap Assessment
- Generation and Execution of Protocols/Reports (IQ, OQ, PQ)
- Acceptance Criteria and Deficiency Report
- Change Control
- Corrective and Preventive Actions
- Final Submission of All Reports
- Validation Summary Report