Industries
Pharmaceutical
Prove the equipment is fit, and prove who signed.
A pharmaceutical plant spends as much effort proving the work was done correctly as doing the work. The qualification file, the gauge certificate, the deviation, the second signature. Most of that proof still sits in a binder, a spreadsheet and a calendar reminder.
Validation & Qualification holds it as records instead. One register per machine, per utility, per process and per cleaning procedure, with the stages and the expiry on the screen. The stages run in order: DQ (design qualification), IQ (installation), OQ (operation across the range), PQ (performance with the real product). The system refuses to approve OQ while IQ is open. How strict the gate is can be set per machine: off, warn, or block the work order. Cleaning limits are computed by the server, not typed into a sheet. Ongoing monitoring hands over to In-Process and SPC (statistical process control).
Calibration proves the gauges behind every one of those decisions. A failed instrument is quarantined until QA releases it. Separation of duties is enforced rather than requested: the person who performs a calibration cannot approve it, and the engineer who investigates a deviation cannot approve the decision on the material. Electronic signature is a switch, set per action.
What hurts today
- Qualification status lives in a binder and a calendar reminder.
- A lapsed qualification turns up in the audit, not before the batch.
- The approved protocol is a PDF on a share drive. Anyone can swap it.
- Cleaning limits are typed into a spreadsheet nobody re-checks.
- The gauge behind a released batch was out of calibration.
- The investigator signs off their own conclusion.
Where plants like yours start
Nobody turns on every module at once. This is the usual first set. A module that is not built yet carries its status on the card.
Validation & Qualification
Prove the equipment and the process are fit. Block work when they are not.
Calibration
Prove every gauge measures correctly.
Quality (NCR & CAPA)
Register a defect. Find the cause. Fix it for good.
In-Process & SPC
Measure the process. See it drift before it makes scrap.
Permit to Work
Nobody works on a machine until it is safe and locked out.
The rules you work under
Pharmaceutical plants work under EU GMP (good manufacturing practice), including Annex 11 for computerized systems, and under FDA 21 CFR Part 11 where they ship to the United States. Phasis provides what those rules ask of software: the audit trail, the second-person approval and the electronic signature. Compliance rests on the plant's whole quality system, not on the software alone.
See it on your own plant.
Thirty minutes with an engineer. We walk the modules you care about against your own lines and shifts.