ENSURE COMPLIANCE WITH CONFIDENCE
Comprehensive IQ/OQ/PQ Validation Services for your Chromatography Systems
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.
What’s Included in a Validation Package?
We tailor each validation to your installation and operating environment. All documentation and procedures are designed for audit-readiness.
IQ OQ PQ
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
Ready to Validate?
Our validation engineers are ready to help you get compliant — and stay compliant.
Email us directly at sales@chromperfect.com