The validation of equipment, systems, and processes is essential to ensure that they function correctly, safely, and according to specifications. The IQ/OQ/PQ model is an established methodology in the pharmaceutical, cosmetic, food, medical, and electronic industries, especially those following standards such as GMP, ISO 13485, FDA 21 CFR Part 11, and ANVISA RDC 665/2022.
To validate is more than to test — it is to prove, document, and ensure it works as it should, always.
🧩 What do IQ, OQ, and PQ mean?
| Stage | Meaning | Main Objective |
|---|---|---|
| IQ | Installation Qualification | Verifies if the equipment is installed correctly |
| OQ | Operational Qualification | Tests if the system operates according to defined parameters |
| PQ | Performance Qualification | Confirms that the system works under real usage conditions |
🧪 When to apply IQ/OQ/PQ?
- Installation of automated test benches
- Implementation of measurement and control systems
- Validation of test software (LabVIEW, TestStand, MES)
- Certification of production lines regulated by ANVISA or FDA
- Compliance with ISO or GMP audits
🔧 How AJOLLY Testing supports projects with IQ/OQ/PQ
AJOLLY Testing offers complete validation solutions, with technical support, documentation, and execution of IQ, OQ, and PQ stages in developed or installed equipment and systems.
🛠️ Validation of test stations
- Verification of installation checklist (electrical network, grounding, interface)
- Functional tests according to nominal parameters (OQ)
- Execution of cycles with real DUT in production (PQ)
📁 Complete technical documentation
- IQ, OQ, and PQ protocols and reports with photographic evidence
- Tables of tested parameters, results, and acceptance criteria
- Digital signatures and versioning according to FDA 21 CFR Part 11
📊 Support for compliance and audit
- Alignment with GMP, ISO 13485, ANVISA, FDA, IATF 16949
- Documentation ready for sanitary inspections and quality audits
- Integration with MES/ERP for traceability of qualified equipment
With AJOLLY Testing, you not only qualify equipment — you validate processes, ensure technical confidence, and surpass audits with safety.