SVC-02 · IQ / OQ / PQ
Documentation an Inspector Can Follow
We provide full qualification services for mechanical and computerized systems. Protocols are risk-based, written and executed by our own engineers, under cGMP and GDP, to EU and FDA requirements.
OQ PROTOCOL · STEAM STERILIZERSheet 4 of 9
| Test | Description | Acceptance | Result | |
|---|---|---|---|---|
| OQ-4.1 | Chamber leak rate | ≤ 1.3 mbar / min | 0.6 | PASS |
| OQ-4.2 | Air removal (Bowie-Dick) | Uniform colour change | Uniform | PASS |
| OQ-4.3 | Empty chamber heat distribution | 121-124 °C, ≤ 1 K spread | 0.7 K | PASS |
| OQ-4.4 | Alarm: door open in cycle | Cycle aborts, alarm logged | Logged | PASS |
Executed by · ____Reviewed by QA · ____
Deliverables
What You Receive
Every package is built so a reviewer can trace each requirement to the test that proves it.
- VMPValidation plan defining scope, approach and acceptance criteria
- RARisk assessment that sets the depth of testing for each system
- IQInstallation qualification protocol and execution
- OQOperational qualification protocol and execution
- PQPerformance qualification protocol and execution
- TMTraceability matrix from requirements to test results
- VRFull validation report, ready for QA release
Method
The V-Model
Each specification is verified by a matching qualification stage: user requirements by PQ, functional specification by OQ, design by IQ.
Experience
Systems We Qualify
cGMPGDPEU GMPFDA
Clean utilitiesWater systemsClean rooms & HVACLab equipmentProcess equipmentPackaging linesControl systemsQMSTrack & trace systemsSteam sterilizers & ovensWarehousesRefrigerators & freezers
Other services
One Team, Five Disciplines
Planning a Facility, a Line or a Validation?
Tell us what you are building. An engineer will get back to you.