Do i need to validate my issue tracking tool for software problems?
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William55401
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yes, you have to validate quality system software. There are various approaches available. This may be a dated reference but consider following GAMP V
If it is keeping records, you need to make sure it does the things a record-keeping system needs to do.
If it is recording approvals, you need to make sure it is doing the things a signature-using system is supposed to do.
Write the requirements for the system, test the system against the requirements. You should probably map your process out and include which parts of the process are addressed by the software.
Don't waste time investigating GAMP 5 for this. GAMP 5 has a heavy focus on software used in production, folks who try to adapt it for general business software (including QMS-related software) make mountains of paperwork for little return. Also, GAMP 5 is an expensive resource. See here...
First things first, you need a process and procedure. All software used within a QMS need to be evaluated for impact, but not all software needs validation. You're going going to validate Google Chrome, but without that procedure written to say complete Form 123 to evaluate ABC Software, you're just going to drown in software validation by validating everything. Create a form that records the software's description, evaluates for potential impact on product quality and patient safety, Part 11 requirements, metric requirements, and determine if all, some, or none of the software requires validation. Draft your procedure in a way to clearly define, a risk score, criteria, etc., for when validation is actually required. Clearly there's a difference between validating an eQMS Platform and Google Chrome, but your procedure needs to explain why.
Please do not use GAMP 5 to validate QMS software. ISO 80002-2:2017 is a good resource that's built on Risk Management, along with the FDA's draft on CSA: Computer Software Assurance for Production and QS Software guidance
Please do not use GAMP 5 to validate QMS software. ISO 80002-2:2017 is a good resource that's built on Risk Management, along with the FDA's draft on CSA: Computer Software Assurance for Production and QS Software guidance
Think about software updates and how you handle them. Do you allow some updates but not others? Is the software locked down "forever". We did this to prevent virus infections from the Conficker Virus.
62304 requires you to have a documented process for software maintenance (Clause 6).
62304 requires you to have a documented process for software maintenance (Clause 6).
SW validation neccesity is always derived from the intended purpose of the SW.
So, first understand, what is the specific purpose of the SW in your process or process task? (without this, your validation will not be focused)
If the SW is used for e.g. electronic recording/archiving, electronic signatur, or for automating process steps (without human control possibility),
then you typically need to validate it (for the intended purpose in context of your process).
The whole approach of SW validation needs to be conducted based on an established QMS procedure (important: risk based).
As already indicated, ISO TR 80002-2 may be very helpful for this topic.
So, first understand, what is the specific purpose of the SW in your process or process task? (without this, your validation will not be focused)
If the SW is used for e.g. electronic recording/archiving, electronic signatur, or for automating process steps (without human control possibility),
then you typically need to validate it (for the intended purpose in context of your process).
The whole approach of SW validation needs to be conducted based on an established QMS procedure (important: risk based).
As already indicated, ISO TR 80002-2 may be very helpful for this topic.
