QualSim: guided IQ/OQ/PQ
Qualification protocols take weeks to write and years to learn.
- Walks an engineer from user requirements and installation checks through operational studies, performance runs, and close-out, explaining what an auditor expects at each step.
- Drafts the protocol with AI, then runs a gap check against the requirements before anyone signs.
- A process-window simulator predicts whether performance qualification will pass before material is spent. Capability indices, tolerance intervals, and deviations run in ordinary, tested code.
Built for manufacturers qualifying new equipment, validating or requalifying a process, and engineers learning validation.








