Prove it works in your process, for your users.
User-role driven PQ, tied back to the URS and CSA risk. Includes stability of use, edge-case scenarios and post-go-live monitoring hooks.
Performance Qualification demonstrates a system performs in the real operational context — trained users running their own workflows, representative data volumes, complete business processes, in the production environment. PQ executed in a development environment, or reduced to a second Operational Qualification with different credentials, is a recurring audit finding.
Outcomes you can expect
- Executed PQ package
- User-role trace matrix
- Post-go-live monitoring plan
Performance Qualification (PQ) Services is delivered by our validation & compliance services practice. Where it saves time, the team uses our products: GxP Copilot for validation lifecycle work and TraceDraft for clinical documentation.
Explore related capabilities: Computer System Validation (CSV), Computer Software Assurance (CSA), AI Validation Services (Annex 22), FDA 21 CFR Part 11 Compliance.
What PQ Tests That OQ Cannot
Performance Qualification tests the system under real conditions: actual users, actual data volumes, and the actual production environment. OQ tests configured behaviour under controlled conditions. PQ answers whether the system performs reliably when operated by the people who will actually use it, processing the data volumes that production generates. Most gaps that OQ does not surface — response time under concurrent user load, audit trail completeness under high-volume batches, backup and recovery time against actual production data — only appear in PQ.
A representative PQ protocol specifies production-representative data volumes (not test minimums), the actual user workflows operators will perform including concurrent use scenarios, the actual production environment rather than a cleaned-up test state, and specific measurable performance acceptance criteria for response time, data accuracy, backup duration, and recovery time appropriate to the regulated use case.
Operator Involvement and System Release
PQ is where the human element enters the qualification lifecycle. Operators who will use the system in production must participate — not because they are better testers, but because PQ is also a test of whether the training programme is adequate. Every PQ participant must have completed system training with documented records in the QMS before PQ begins. We coordinate training documentation requirements with the site training function as part of PQ preparation.
The PQ summary report closes the qualification lifecycle and provides the basis for the formal system release decision. It summarises test cases executed, deviations raised and resolved, performance against acceptance criteria, and the QA reviewer's conclusion that the system is suitable for production GxP use. Following release, change control, periodic review, and ongoing validation maintenance obligations begin.
See it on your own system.
Bring a URS or a system. We show you the validation package it produces.
- We reply within one business day
- We run your URS live on the call
- You get a clear plan and scope