Validation Services

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)