IQ/OQ/PQ Protocols That Live in the System, Not in Filing Cabinets
Validation Protocol Builder
Define multi-phase validation procedures (Installation Qualification, Operational Qualification, Performance Qualification) with sections, fields, calculation builders, and pass/fail evaluations. Protocol definitions are stored as versioned units, loaded and executed consistently every time.
A two-tier equipment specification catalog links manufacturer reference data (weight, dimensions, evaporation rate, capacity) to your specific equipment units. Spec values feed into protocol calculations automatically.
Performing and Reviewing Validations
Operators fill out the protocol form, enter measurements, and see calculated results in real time. They can save progress, then sign and submit when complete.
Dual-signature enforcement ensures the operator who performs the validation cannot be the same person who reviews and approves it. The system enforces this by checking user identities, not by relying on policy alone.
Revalidation Scheduling
Protocols define revalidation intervals (for example, annually). The system tracks when equipment is due for revalidation and sends alerts based on configurable lead times. No more missed deadlines discovered during an inspection.
Validation History
Complete record of every validation performed on every piece of equipment: who performed it, who reviewed it, what the measurements were, whether it passed or failed. Instantly retrievable during an audit.