At PACIV, we ensure with documented evidence, that our automation systems are delivered and implemented
meeting their functional intent and that your requirements and approved design are aligned to deliver you a sustainable and reliable automation solution. Our Commissioning and Qualification (C&Q) and Computer System Validation (CSV) services ensure that the development and implementation process runs smoothly, systems are properly handed over and can be maintained in a validated state through their useful lifecycle up to retirement.
Our full C&Q/CSV Life Cycle services include consultancy, planning, development, and execution tailored to meet your corporate policies, procedures, and validation methods while applying ISPE GAMP™ and C&Q Guidelines. In addition, we provide all needed supporting services during the Operation and Maintenance phase of the validated systems such as development and execution of CSV SOP’s for System Administration, Configuration Management, Back-up, Disaster/Recovery, Security, Periodic Review, and System Retirement.
Our C&Q and CSV Services include:
- Risk-based Management Process following FDA, ICH Q9, ASTM 2500, and ISPE (GAMP and C&Q)
guidelines - Gap Assessments
- Consultancy for FDA 483’s and/or Warning Letters handling (responses and remediation initiatives)
- Full CSV/C&Q Life Cycle full Services
- Commissioning & Qualification (C&Q ) Planning, Development and Execution
- CSV Planning, Requirements, Functional and Design Specification, Traceability Matrix, Final Reports
- Vendor Evaluations and Qualifications
- Development and Execution of Testing Protocols (FAT, SAT, IQ, OQ, PQ)
- Traceability Matrix, Master Document Lists, Reporting
- Validation Maintenance SOP’s (System Admin., Configuration Management, Security Administration, Backup/Restore, Disaster/Recovery, Business Continuity Plan, Periodic Review, System Retirement)