Validation & Compliance
Equipment Qualification
From user requirement specification to performance qualification, we document and execute the full qualification lifecycle, so new and modified equipment goes into GMP use with evidence that stands up to audit.
What's included
Scope of service
Design Qualification (DQ)
Review of design against URS and GMP requirements.
Installation Qualification (IQ)
Verification of installation, utilities, materials and documents.
Operational Qualification (OQ)
Functional testing across operating ranges and alarms.
Performance Qualification (PQ)
Proof of consistent performance under routine conditions.
Typical equipment & systems
- Autoclaves & dry heat sterilisers
- Fluid bed dryers & RMGs
- Tablet compression & coating
- Purified water & WFI systems
- Compressed air & nitrogen
- Stability chambers & cold rooms
- LAF, RLAF & pass boxes
- Lab instruments
What you receive
- URS review and qualification master plan
- DQ / IQ / OQ / PQ protocols
- Executed protocols with raw data
- Qualification summary reports
How we work
Four steps, fully documented.
- 1
Understand the requirement
Site visit or call to map your instruments, equipment, URS and audit timelines.
- 2
Plan & execute
Approved protocols, calibrated master standards and trained engineers on site.
- 3
Deliver results & reports
Signed certificates, raw data and validation reports in your QA format.
- 4
Ensure compliance
Due-date tracking, re-qualification planning and support during audits.
Can you work with the OEM's qualification documents?+
Yes. We review OEM-supplied documents, close the gaps against your URS and site SOPs, and integrate them into your qualification package.
Related
Other services
Let's plan your equipment qualification.
Tell us what you need. We'll come back with a plan, a timeline and a clear quote, usually within one working day.