Continuous Monitoring System Performance Qualifications or Test SOPs: How to Meet Your Quality Management System Requirements

Pharmaceuticals production line workers
Profile picture for user paul.daniel
Paul Daniel
Sr. Regulatory Compliance Expert
Dec 18th 2013
Industrial Measurements
Life Science
Science & Sensing Technologies

This week we received a question from a blog reader on PQs for environmental monitoring systems.

Add new comment

Dear Paul, I’ve reviewed several of the Vaisala validation webinars, but I wanted to ask a question specific to my facility's continuous monitoring system. Are there canned PQ scripts that we can adapt to our system? I would like to perform a robust valid

Dear V, First off, thank you for checking out our webinar series and for reaching out! We are currently working on some “canned PQ” scripts, but they probably won’t be ready to share with customers until Spring 2014.
However, you will find this very easy to do on your own. If we do a quick risk assessment with the standard parameters (likelihood, severity, and detectability) it becomes clear that a monitoring system software, even one as adaptable as Vaisala's viewLinc, has relatively few critical functions:

The critical elements are simply:BLOG-IMAGE-SAMPLE-VAISALA
1. Reporting of data (so that we can make GMP decisions based on the reported parameters.)

2. Automatic generation of reports (this only if your Quality System has integrated automated report generation as part of your procedure.)

3. Alarming - Thresholds and Communication (this only if your Quality System has proceduralized analysis of alarming as part of your release criteria. However, you may want to include it anyway as it can protect product so well.)

Most other system elements are either less important or non-configurable (and so are tested by OQ or system testing by Vaisala). If you integrate them into your Quality Management System, you might consider the following elements critical as well:
1. Notification schedules
2. Alarm Acknowledgement Comments as a vehicle for team communications
3. Calibration Alarms

So, my approach (and the one I am using for the PQ documents we are currently creating) is to make a generic PQ protocol that includes worksheets with blanks that you can fill in with the required parameters for the given location/report/alarm. Include in your worksheets parameters such as delays, thresholds, notification recipients. You should be able to access this right from your Monitoring SOP or Policy. If you don’t have a policy or SOP that states these values, then you probably don’t have a process to validate/PQ.

Another way to play this is to skip the PQ, but have an annual alarm testing SOP. You can use this SOP as the vehicle to test your alarms (which you should do annually anyway). and simply verify that the procedure is in place and has been performed within the last year.

These are just a couple ideas to guide you in this process. I apologize that we aren’t at the place where we can offer you the PQ documents... soon, I promise!

Also, I am happy to review anything you put together and give input!

The basic process is to challenge each location/alarm/report. Use parameters for each function that are included in your existing Quality Management System documents. Often we run into customers that want to do a PQ, but have no process to validate because they haven’t integrated the system functions into their Quality Management System.

Let me know how I can be of further assistance and good luck!
Best regards,
Paul