Frequently Asked Questions

image1

What Guideline to be followed for CSV ?

The system shall be validated as per ISPE baseline guide GAMP5.

image2

What will be checked in PLC qualification.

The Input Output verification, Alarm challenge test and Functionality test.

image3

Are you doing the qualificationof computer systems for Europeon Union?

We are validating the system  as per EUGMP i.e. Annex 11 and  for USFDA we are doing with 21 CFR Part 11.