Expertise / Qualification & Validation
Equipment qualification and GxP system validation.
A test proves only what it was meant to verify.
We prepare or execute qualification activities (IQ/OQ/PQ) and computerised system validation (CSV), within the scope entrusted to us.
For EMS and thermal chambers in particular, our skills in thermal mapping, calibration and instrumentation help define tests suited to the intended use and to GxP risks.
We work alongside your engineering and Quality teams, respecting the review and approval responsibilities that have been defined.
Technical expertise
Tests rooted in how systems actually work
Relevant qualification rests on understanding critical functions, operating limits and failure modes. Our technical skills make it possible to define checks suited to the systems concerned.
EMS & Monitoring
Verification of the measurement and alarm chain, from acquisition to notifications, with failure scenarios matched to the risks: loss of communication, power interruption or transmission fault.
Thermal chambers
Qualification based on thermal mapping, analysis of uniformity and stability, and identification of the relevant positions for permanent monitoring.
Instrumentation
Verification of calibrations, their traceability and the suitability of uncertainties for the measurement requirements, beyond the mere presence of a certificate.
GxP computerised systems
Verification of critical functions, access rights, audit trails, backups and restoration, according to the intended use and the risks identified.
Key point: thermal mapping or calibration provides evidence for a qualification, without replacing it.
Requirements & evidence
What was required, what was tested, what was observed
Rigorous qualification does not rest on the number of tests, but on the relevance of the checks and the strength of the documented evidence.
Requirements & risks
User requirements, intended use and risk analysis determine the checks needed. For computerised systems, GAMP 5 serves as a good practice guide.
Criteria & tests
Protocols and acceptance criteria defined before testing. IQ/OQ/PQ activities and CSV checks suited to the system. FAT/SAT results can be reused where their relevance is justified and documented.
Traceability & deviations
A matrix linking requirements, tests and results. Deviations investigated, impacts assessed and conclusions documented in a report submitted for the reviews and approvals set out in the client’s quality system.
Change control
When a system changes, what needs re-verifying?
A change does not automatically call for full requalification. Impact assessment identifies the functions affected and justifies the checks to repeat, as well as those deemed unnecessary, within the client’s change control process.
Changes & extensions
Chamber moved, controller replaced, sensor added or alarm threshold changed: assessment of the impacts and definition of the tests or mappings required.
Migrations & software changes
Update, change of server or interface: analysis of the impacts on critical functions, data exchanges and their integrity, with targeted checks.
Maintaining the qualified or validated state
Periodic requalification of equipment where required and periodic review of computerised systems, at justified frequencies and against justified criteria.
Applications & assignments
When to call on MAJ to qualify or validate?
Targeted intervention
A file to review before an inspection, a change to assess or additional tests to define. We work on a specific need, with an agreed scope and deliverables.
Typically Impact assessment after an EMS change, identifying the checks to repeat.
Support for your teams
Your engineering or Quality teams, or your suppliers, need additional skills. We prepare or execute protocols and follow up deviations, on a defined assignment and for a defined period.
Typically Support for qualifying chambers based on thermal mapping results.
Taking on a complete scope
A piece of equipment or a GxP system to qualify or validate. We take on the agreed activities, from requirements to report, respecting the client’s approval responsibilities.
Available experience Qualifying an EMS through to PQ.
Contact
Tests to prepare, a qualification to structure?
Tell us about the equipment or system concerned, the context (new installation, change or requalification), the documents available (URS, existing protocols) and your deadlines. At a first discussion, we clarify the scope of our work, the responsibilities for writing and execution, and the review and approval process set out in your quality system.
Describe your needDirect contact: info@maj-solutions.be +32 475 92 05 37