Commissioning – Qualification Validation

CoCEPTIO is capable of defining needs
to take charge, establish strategies and
demonstrate commissioning in a documented manner,
qualification or verification (according to standards and
methodologies “V” cycle, ASTM E2500) of systems
and equipment considered non-critical
and criticism, in order to guarantee the customer a
installation compliant with expected performance as well
as well as the various regulatory constraints (GMP
Good Manufacturing Practices, PIC/S,…).
Our focus is on quality through design
(Quality By Design) and on “Right First Time”.
Our requirement is such that this phase does not guarantee
not only that your installation is safe, efficient
and compliant. It also guarantees that our services are
in line with customer expectations.
• V-cycle approach, ASTM E2500, hydride, …
• Risk analysis
• Qualifications:
° Validation Master Plan
° Design (“DQ”)
° Installation (“IQ”)
° Operational (“OQ”