Cleanliness is a state. Without evidence, it remains a claim.
Services
Plan, risk assessment, requirement and evidence belong together. That is why we cover the whole chain, and you have one contact instead of several interfaces.
01
DQ, IQ, OQ and PQ for cleanrooms, HVAC systems, compressed air, pharmaceutical water and process equipment. We derive the test scope from the risk assessment.
02
Qualification master plan, risk assessment, URS, room book, test plans and SOPs. Every requirement can be traced to its evidence.
03
Joining running projects, Annex 1 gap analyses and audit preparation. At the end you know where you stand and what to do next.
Additional
Calibration of quality-relevant instruments and sensors for temperature, humidity, differential pressure and air velocity, mobile or permanently installed.
Qualification chain
The qualification master plan defines the objects and their interfaces. The risk assessment shows what is critical. From this comes the URS against which qualification is measured.
QMP
Define objects, interfaces and scope
Risk assessment
shows what is critical for product and patient
URS
GMP-relevant requirements only
DQ
User requirements against supplier specification
IQ · OQ · PQ
Expected against actual, with evidence
Approval
Report, then requalification
Life cycle
The work does not end at start-up. Changes, requalifications and inspections all draw on the same documents.
Design
Concept, room book, URS
Construction
FAT, SAT, commissioning
Qualification
DQ to PQ
Operation
SOPs, calibration, monitoring
Change
Change control, requalification
Contact
Briefly describe the system, project phase and timeframe. We will propose a suitable scope.
