Consulting Services

Compval provides hands-on Computer System Validation (CSV) support, including:

• Identifying the validation and test strategy that matches your application and business needs
• GxP classifications and risk assessments
• Validation policies, plans, and procedures
• Commissioning and qualification documentation
• Vendor and supplier audits
• Verification of vendor testing
• Vendor lifecycle support where documentation is deficient
• Test protocol development and execution
• QA oversight of supplier software development
• Gap analysis of existing computer systems against current industry expectations
• Remediation of identified gaps
• Pre-regulatory audit reviews
• 21 CFR Part 11 assessments
• Data integrity assessments against current guidelines

Compval also provides training material and document templates, written with GAMP 5, EU, and FDA requirements in mind — available through the CSV 101 course, or tailored for a specific company's needs.

For something more specific, email admin@compval.com.

Not sure where to start? Try the free GxP Readiness Planner to see where your system stands, or book a conversation about your specific situation.