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ChromperfectSystem Validation Services

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System Validation for Regulatory Compliance: Chromperfect has delivered fully validated chromatography data systems for over 30 years. Whether you`re working in pharmaceutical QA/QC, petrochemical R&D, or contract laboratories, we provide everything needed to validate your CDS with confidence. Our validation services are designed to support FDA 21 CFR Part 11 compliance and meet modern expectations for electronic records and signatures.

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We tailor each validation to your installation and operating environment. All documentation and procedures are designed for audit-readiness.

Installation Qualification (IQ)

  • Confirmation of proper software and driver installation
  • Verification of hardware, firmware, and OS compatibility
  • Network configuration and storage settings

Operational Qualification (OQ)

  • Test and verify core software functionality
  • Confirm electronic signature setup and access control
  • Audit trail verification
  • Ensure system security and user group permissions

Performance Qualification (PQ)

  • Real-world test methods to confirm system suitability
  • System precision, accuracy, and linearity checks
  • Benchmarked performance using your instruments or standards
  • Additional Features & Compliance Checks
  • Electronic Signatures: Full implementation with reason for change capture
  • User Access Control: Role-based groups with defined permissions
  • Audit Trails: Reviewable, traceable system logs
  • System Suitability: Sample sets, retention time stability, peak area consistency
  • Hardware Validation: If Chromperfect supplies your system, we validate PC + instruments
  • Traceability Matrix: Links every test to a specific requirement

What You Receive

  • Signed and dated IQ/OQ/PQ reports
  • Complete documentation set for audit trail review, including validation summary and traceability matrix
  • Validation summary and traceability matrix
  • Optional remote or on-site execution
  • Need Re-Validation or Annual Review?
  • We also offer re-validation services for:
  • Software version upgrades
  • New instrument integrations
  • Corporate policy changes
  • Periodic compliance reviews