Where does a Periodic Review Document reside?

COMPUTER SYSTEM VALIDATION (CSV)
1

Hello All,

When performing periodic reviews for computer systems where does the periodic review document reside.

Do you generate a periodic review document per system or do you have a log for all systems that is updated?

Also what items should you include as part of the Periodic Review process?

Thank in advance.

2

Hi Graham,
When I perform the periodic re-evaluation for computerized systems I generate one report for each equipment, in case of similar equipment with same re-evaluation expiration date I can made a group in the same report.
System included are:
-IT Aplication (only software without field)
-Process Automation (SCADA, PLC, DCS etc)
-Lab System (yes for HPLC, Spectrophotometer etc and no for bench pH meter, conductivity meter etc)
The frequency of the revaluation is determined during the first qualification of the system and depend on the criticality of the system defined by a system impact assesment.
Regards
Alberto

3

Thank you Alberto…this makes sense to me…how do people know when they need to carry out a periodic review?

Have you an automated system?

4

We have an automated system for calibration but not for re-evaluation and so every year we made a plan with the scheduled workload.
Regards
Alberto

5

Thank your for the clarification :slight_smile:

6

“Lab System (yes for HPLC, Spectrophotometer etc and no for bench pH meter, conductivity meter etc)”

I think that bench pH meter, conductivity meter etc. should be executed for computer validation in accordance with Quality Impact Analysis
However, Computer validation is related with Re-PQ of instruments . So that just makes a matrix and reports that information.
Like this, when QC instruments are executed for re- PQ, there should be at least CFR part 11(as Audit trail and password management etc.) for Computer validation during Re- PQ items.