Hello Vera,
There are a couple automated compliance tools out there, though have to look at 1) will it complete activities which you desire and 2) is the cost beneficial. Personally, I have just developed spreadsheets over the years which have the requirement listed, plain language of the requirement, compliance (Yes/No), and proficiency or deficiency statement. This may also depend on how often you are completing gap assessments or audits as a frequent tool may be advisable to invest. However, if only doing once a year, maybe another simpler tool like a spreadsheet would suffice. I have even just used Word creating tables with the similar information (Word documents are just easier to format and move around than Excel).
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 01-Aug-2022 15:56
From: vera diaz
Subject: How do you perform gap assessments?
I am curious to know how others manage compliance and gap assessments to ISO standards. Are you managing gap assessments and compliance in spreadsheets that you manually curate or utilizing any software? I am eyeing RIMSYS as a possible solution but it might not be cost effective for us.
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vera diaz
Tampere
Finland
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