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  • info@provalhelp.com
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Computer System Validation (CSV)

Computer System Validation (CSV)

Pro-Val resources will ensure that your computerized systems are developed and qualified following a structured life cycle approach consistent with the Good Automated Manufacturing Practice (GAMP5) guidance and meet all applicable sections of cGMP/GLP/GCP and 21 CFR Part 11.

Our CSV services are designed to ensure that you are in compliance with the applicable sections of the cGMP/GLP/GCP and 21 CFR Part 11. This process will assure the quality of computerized systems through the development and/or execution of requirements, specifications, design, coding, testing, installation and acceptance. Pro-Val takes a risk based approach to CSV that is in compliant with applicable regulations and current industry standards ((Good Automated Manufacturing Practices (GAMP5) and ASTM E2500)). This process includes the following steps customized to your unique needs:

  • Supplier/Vendor Audits
  • Client Validation Life Cycle Audit
  • 21 CFR Part 11 Audits/ Remediation Plans
  • Policies & Procedures Development
  • Software Validation
  • Validation Plans
  • Disaster Recovery Plans
  • Operation & Security SOPs
  • Change Management and Control
  • System User Requirements and Design Documents
  • Protocols, Test Plans, Test Scripts
  • 21 CFR Part 11 Training
Computer System Validation