Dear All
ASTM E2500 is Good Engineering Practice (GEP), it is directly impact to validation process (IQ, OQ, PQ) by using Commissioning & verification.
Some companies exclude Clause 7.5.2 (ISO 13485:2003), because they said they do Commissioning & verification.
Do anyone have some idea about this finding?
:argue:
DRDDO

Can someone help?

Although there are many simmilarities, the focus of GEP and qulaification are different.

GEP focusses on the safety and operability of the system which is commissioned and ensures the acceptance of the system before start-up. The acceptancetests are frequently performed by the constructors and withnessed by the user.

Qualification focusses on the quality of the product that will be manufacted by using the system. Generally, when a system has impact on the product it should qualified in addition to the acceptance tests performed during commissioning. Test from the commissioning do not need to be repeated, but may be leveraged during the qualification.