Two Partners. Two Practical Principles. One Powerful Approach.
The Practical Solutions Group, LLC
152 Witherspoon St.
Princeton, NJ 08542
P: 609.683.0756
F: 609.683.0758

Computer Systems Validation

Computer Systems Validation/21 CFR Part 11 

  • Develop and implement computer system qualification and validation strategies
  • Assess and document regulatory compliance
    and operational system risks
  • Develop documentation (e.g., master / test / remediation plan, lQ/OQ/PQ protocols, reports, traceability, requirements, SOPs, UAT)
  • Provide 21 CFR part 11 regulatory training
  • Develop 21 CFR part II interpretation
  • IT infrastructure planning and assessment
  • Evaluate operational, development, testing and/or documentation issues for 21 CFR part 11 compliance, HIPAA and Safe Harbor