Expertise
A test proves only what it was meant to verify.
GMP/GxP, FAT/SAT, IQ/OQ, CSV, GAMP5, data integrity.
Criteria set before the test, traceability from requirement to result.
In a regulated environment, a test result is assessed against a requirement, an acceptance criterion and the intended use of the system. We prepare or execute the qualification and validation activities for your equipment and systems, EMS and computerised systems in particular, and document the results alongside your engineering and quality teams.
What we do
Before, during and after testing, according to the agreed role.
- clarify user requirements, risks and acceptance criteria before writing the protocols
- prepare or execute factory and site acceptance tests (FAT/SAT)
- prepare or execute installation and operational qualification (IQ/OQ)
- contribute to computerised system validation (CSV): requirements, tests, deviations and conclusions kept together
FAT/SAT testing does not amount to a qualification on its own. It can feed into one when the project provides for it.
In which situations
Before a start-up, or when a qualified system changes.
- a piece of equipment or an EMS must be qualified before it goes into operation
- a computerised system must be validated for its intended use
- a change, an extension or a migration calls for assessing the impact and deciding which checks to repeat
- your teams need support to write the protocols, run the tests or consolidate the results
With what
An approach proportionate to risk, aligned with your quality organisation.
- the applicable GMP/GxP requirements, identified according to the system and its context of use
- a risk-based approach for computerised systems, with GAMP 5 as a good practice guide
- acceptance criteria and protocols set before testing
- data integrity checks targeted to the scope: access, records, audit trail, backups
What it produces
A file that states what was required, what was tested and what was observed.
- requirements and a risk assessment to which every check is traced
- completed protocols, with the test evidence
- traceability between requirements, tests, results and deviations
- summary reports and open-item tracking, ready for review by your teams
Our role, the deliverables and the review and approval responsibilities are defined at the start of the assignment.
Six areas of expertise
Tests to prepare, a qualification to structure?
Tell us about the system concerned, the project phase and the requirements already identified. Together we will work out the support your teams need and the documents to prepare.