IQ, OQ & PQ Services
GMP/GDP Validation & Compliance
Formal validation packages for regulated environments. Complete IQ/OQ/PQ documentation, validation protocols, and audit support for GxP, GDP, GMP, and FDA 21 CFR Part 11 compliance.
All Validation Service Offerings
Included & Add-on Capabilities
Included Standard Features
Validation Master Plan
Complete validation planning documentation
IQ/OQ/PQ Protocols & Reports
Full protocol and report packages
Risk Assessments
Comprehensive risk analysis
Optional Add-ons
On-site Audit Support
Expert support during audits
Annual Revalidation
Yearly revalidation services
The Validation Process
Planning
Validation Master Plan defining scope, approach, and acceptance criteria.
IQ — Installation
Verify system is installed per specifications and documentation.
OQ — Operation
Confirm system operates within defined parameters under test conditions.
PQ — Performance
Prove system performs reliably under real-world operating conditions.
Frequently Asked Questions
Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) are formal validation stages that prove a monitoring system is installed correctly, operates within specifications, and performs reliably under real-world conditions.
Typically required for GxP, GDP, GMP, and FDA-regulated environments where monitoring systems must be formally validated before use.
Yes. Complete Validation Master Plan, IQ/OQ/PQ protocols, execution reports, and risk assessments are included.
Yes. Expert support during regulatory audits and inspections is available as an add-on service.
Annual revalidation is recommended and available as an add-on to ensure ongoing compliance with regulatory requirements.
Yes. Readiness assessment and compliance documentation for FDA 21 CFR Part 11 electronic records and signatures requirements.