Computerized System Periodic Review Requirement - Pharma Company

I work for a pharma company and we have a computerized system periodic review requirement. WE are aware of the criterias to take into consideration when doing a periodic review and what to review (change controls, SOPs, validation docs, etc) and document but are kind of baffled as to how to trigger and monitor the periodic reviews. It's a pretty big company with many computer systems. Is there a software out there or can you share how are you handling this?

qualitydocs said:

I work for a pharma company and we have a computerized system periodic review requirement. WE are aware of the criterias to take into consideration when doing a periodic review and what to review (change controls, SOPs, validation docs, etc) and document but are kind of baffled as to how to trigger and monitor the periodic reviews. It's a pretty big company with many computer systems. Is there a software out there or can you share how are you handling this?

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I'm not exactly sure I understand your question since you say you already do periodic reviews.

I'm sorry I wasn't clear. We have the requirement in an SOP for periodic reviews for computer systems and it's pretty clear who does it (team of who owns the system, quality and IS: whoever owns the system in the dept is supposed to initiate the review) how to do it and what to review and report. The SOP also requires the timeframe and frequency to be documented and justified based on risk. But we've had some issues where the periodic reviews were missed and I want to know how other companies are handling the monitoring and scheduling. DO you have a master schedule and who monitors it (Quality or Dept who owns the system?) or is it controlled with a software if so what is the software name. So we are semi-doing it but not consistently. So if the Validation Plan and risk assessment says the first periodic review should be 1 year after system release and then every 2 years after that..sometimes that's not done. I hope that makes sense? Any information you can give me on how you handle computer system periodic reviews and make sure they get done would help at this point.

I have moved the question to this section to get more specific responses.

One way of doing it is by publishing a Master Validation Plan which lists ALL periodic revalidations (computerized systems, Process, equipment, facility, sterilization, etc.).

Then you give this document visibility by performing periodic MVP review on periodic a Manager-level meeting (i.e. Quality/Management Review).

You then determine the most appropriate time-frame of reviewing the MVP and keeping it up to date.

Hope this helps.

qualitydocs said:

I work for a pharma company and we have a computerized system periodic review requirement. WE are aware of the criterias to take into consideration when doing a periodic review and what to review (change controls, SOPs, validation docs, etc) and document but are kind of baffled as to how to trigger and monitor the periodic reviews. It's a pretty big company with many computer systems. Is there a software out there or can you share how are you handling this?

Click to expand...

Hi Qualitydocs!

Hope the following points may helpful to develop periodic review on computerized system.

Before conducting the periodic review, classify the system as GMP related computer systems and non-GMP related computer systems and then prepare the writeup on the periodic review for GMP related computer systems.

The points that should be addressed in the review are as follows:

a. System identification number with location
b. Computer system Validation status (includes re-qualification / re-validation if any)
c. Review about computer system security
d. Back up and restoration details
e. Deviations includes Unplanned down time, troubles / system logs
f. Changes to computerized systems (includes changes to company standards, polices & procedures), Up gradations to systems since last review
g. Computer System retirement details

h. Complaints related to the system
i. Computer system access list, adjustment to the computer system access
j. CAPA (includes any regression testing for a system)
k. Tracking (Actions identified from the current periodic review and status for the actions identified from the previous review)
l. Conclusion summary


Regards / Raghu

I agree with the suggestion of Juan, of making he 'review requirement' as a part of MVP.

Triggering :
1)
Since you say that you have large no. of applications to be handled through out the organization;

one way of implementing this is to TIE the review process with [yearly!/]periodic-maintenance [viz., backup/archival procedures...];

i.e., have an SOP which specifies that these routine activities are not approved/started, untill the "application-review-requirements" are met!. [obviously the periodic maintennce if not completed would effect the system performance and hence would trigger the application-review!]

2)
You can make "Review-reports" part of the document management system; which specifies the review-frequency of these report ; [you could indirectly use the DMS to trigger the revision/updation of these reports.

as per the criteria of review:- should also involve the deviations, change in requirements [partly covered in the change controls] and performance attributes/environment.

hope that helps.
thanks
valiveti.

I believe all you are looking for is something that puts out a report that shows what's due and when. You could set this up as an item in your maintenance system (MAXIMO, SAP) or if you use a Trackwise type system for your CAPA you can set it up in there.

No sense in buying new software if you have something already in place.