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Risk assessment and IQ/OQ/PQ protocols

Risk-based IQ/OQ/PQ. 70% less authoring.

GAMP 5 risk assessment first, then protocols where every test traces to its requirement.

Send one URS and supplier docsSee the output
70%less authoring on IQ/OQ/PQ
DraftedURS-022 Data retentionRisk high · OQ-14 drafted
01Avoided re-workMissed high-risk tests caught before execution.
02Cycle timeValidation packages in weeks.
03Labour70% less authoring time.
04Right-sized testingEffort follows risk.
What you get

A verdict on every line. A person signs.

Reference
URS, GAMP 5, intended use
Compared
Supplier docs and system specs
Output
Risk assessment and protocols
Buyer
Validation, equipment builders

70% less authoring time, measured inside a Global Top-10 pharmaceutical manufacturer.

By industry

Where it pays off.

Pharma & Life SciencesRisk-based IQ/OQ/PQ from the URS and supplier documents.Industrial & OEMsFAT/SAT and IQ/OQ packs for your customer.
No call needed

Send one URS and supplier docs.

Get a risk assessment and draft OQ to compare with your approved version.

Get a free gap reportBook a working session

3-week pilot. A backtest on work you have already done. Success criteria agreed up front.

Three questions we’ll ask
  1. How long from URS to approved protocols?
  2. How do you scale test effort to risk?
  3. Who writes the protocols: you or the supplier?
RelatedExecuted protocol and evidence reviewTraceability and change impactRequirements draftingAll use cases →