/ Pharma
Pharma
IQ / OQ / PQ
ICH Q7, ICH Q10, and 21 CFR Part 211. The pharma qualification gate is the PPAP analog for regulated manufacturing.
THE PROVING GROUND
See the gate run on a neighboring artifact. Every part that passes carries the same verified thread.
Where the part lives or dies.
Pharmaceutical equipment qualification demands Installation Qualification, Operational Qualification, and Performance Qualification protocols executed and reviewed against predefined acceptance criteria before GMP production begins. The IQ / OQ / PQ package is the pharma analog of PPAP: every deviation must be closed, every protocol signed, every instrument calibrated and traceable. One open deviation and the equipment is not released.
WHAT THE GATE RECOVERS
60 to 300 hrs
Labour a single submission consumes. About half recovered per verified package.
Toward 95%
First-pass approval rate. Production agents score the full package before it leaves your desk.
Weeks back
Per submission, recovered from review loops and re-test cycles avoided.
1 to millions
Each verified submission authorizes the parts that follow.
Roadmap
Use cases this sector displaces.
- Assembling IQ / OQ / PQ protocol packages against ICH Q7 GMP requirements
- Cross-checking deviation records against acceptance criteria before equipment release
- Tracking calibration certificates and instrument traceability across the qualification lifecycle
- Flagging open protocol deviations before the quality-unit review
START HERE
Bring one part. We run it through the gate.
Declare your part and its submission intent. We run it through the Submission Gate and hand back the verdict and the certificate. One part. One pass. Everything cited.
Today we qualify the equipment. Tomorrow we validate the process.