Documentation an Inspector Can Follow
We validate mechanical and computerized systems so that equipment and processes meet regulatory requirements and work as intended. Protocols are risk-based, written and executed under cGMP and GDP, and your systems stay ready for inspection after hand-over.
| Test | Description | Acceptance | Result | |
|---|---|---|---|---|
| OQ-4.1 | Chamber leak rate | ≤ 1.3 mbar / min | 0.6 | PASS |
| OQ-4.2 | Air removal (Bowie-Dick) | Uniform colour change | Uniform | PASS |
| OQ-4.3 | Empty chamber heat distribution | 121-124 °C, ≤ 2 K spread | 0.7 K | PASS |
| OQ-4.4 | Alarm: door open in cycle | Cycle aborts, alarm logged | Logged | PASS |
What You Receive
Every package is built so a reviewer can trace each requirement to the test that proves it.
- VMPValidation plan defining scope, approach and acceptance criteria
- URSUser requirement specification, written with the people who will run the system
- FSFunctional specification
- RARisk assessment that sets the depth of testing for each system
- DQDesign qualification
- IQInstallation qualification protocol and execution
- OQOperational qualification protocol and execution
- PQPerformance qualification protocol and execution
- TMTraceability matrix from requirements to test results
- VRFull validation report, ready for QA release
- SOPStandard operating procedures aligned with the validated state
Beyond Core System Validation
Documentation Gap Analysis
A review of your cleanroom facility documentation against current requirements, and a remediation plan to close the gaps.
Cleanroom Qualification & Environmental Monitoring
Full DQ, IQ, OQ and PQ for pharma and medical device cleanrooms to ISO 14644 and EU Annex 1, including EM protocols for viable and non-viable particles, surface and air sampling during PQ.
Computerized Systems Validation
CSV with a strong focus on ERP platforms, including Priority ERP: validation planning, risk assessment, requirement traceability, test protocols and reports, to FDA 21 CFR Part 11 and EU Annex 11.
Cold Chain & Transport Validation
Qualification of the pharmaceutical and medical device supply chain, so temperature-sensitive products keep their integrity from the manufacturing site to the end user.
Audit & Inspection Readiness
Audit readiness covering every aspect of cleanroom regulation, validation and computerized system validation (CSV). Hands-on preparation for inspections and audits by the FDA, Notified Bodies (CE marking) and local Ministries of Health, through to a compliant facility hand-over.
The V-Model
Each specification is verified by a matching qualification stage: user requirements by PQ, functional specification by OQ, design by IQ.
Standards We Work To
Systems We Qualify
One Team, Five Disciplines
Planning a Facility, a Line or a Validation?
Tell us what you are building. An engineer will get back to you.