All computer systems and software impacting on product quality must be identified, and the risks in their use evaluated. From large-scale process control through to simple embedded code in a regulated device, pharmaceutical and medical device manufacturers are required to validate GxP-critical systems.
Validation can increase the usability and reliability of the system, resulting in decreased failure rates, fewer recalls and corrective actions, less risk to customers and users.
We ensure that your computer systems are compliant with GAMP 5,FDA, GxP, 21 CFR Part 11,EU Annex 11,organizational quality system (GLP, GMP, and GCP) Other Governmental regulations and industry standards.
Scope Of Work
- PLC base Control systems.
- PLC base Control Systems with HMI/MMI user interface+Camera System.
- PLC base Control Systems with SCADA.
- Micro-Controller base control system.
- Operating Software for the SCADA.
- Equipment Validation (Incubator, Stability,etc..)
Computer System Validation Services Deliverables
- Qualification Doc. : GxP, RA, GAP, CSVP, IQ, OQ, PQ ,(If required),VSR , Test cases (if required) etc.
- Re-Qualification Doc. : RA, Requalification Protocol (Including IQ,OQ,PQ ), Test cases (if required) etc.
- Re-Validation Doc. : Performance Verification Protocol (Including IQ,OQ), Test cases (if required)
Work Flow For Computer System Validation
- Master Validation Plan
- User Requirement Specifications
- Collection Of Raw Data Information And Required Reference Documents
- Gxp Assessent
- Risk Assessment
- Gap Assessment
- Generation Of Protocols/Reports (IQ, OQ & PQ)
- Execution Of Protocols/Reports (IQ, OQ & PQ) & Compiling
- Acceptance Criteria
- Deficiency Report
- Change Control
- Corrective Action & Preventive Action
- Final Submission Of All Reports
- Validation Summary Report