My team of software validation experts has been actively and extensively working on sharepoint validation work during that last couple years. While we don't sell templates, we can certainly use our prior validation documentation experience to assist in the authoring of customized sharepoint validation documentation for the targeted intended use(s). Such documentation includes, but may not be limited to, electronic record/signature applicability assessment (if relevant), GMP applicability assessment, software risk analysis, software validation plan, user/functional requirements specification, software design specification (should still be prepared even for an off-the-shelf application), validation traceability matrix (strongly recommended, but not required), qualification protocols and reports, associated SOPs and training (as needed), etc., and all done in accordance with industry best practices such as GAMP 5, ISO/TR 80002-2, and of course ISO 13485, along with applicable regulatory requirements.
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Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
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Original Message:
Sent: 09-Feb-2021 03:15
From: Mike Kilkelly
Subject: Software Validation of Sharepoint application
Has anyone here experience of validation a sharepoint application. Our application is a database for storing customer complaints and I'd like to avoid re-inventing the wheel. Any suitable templates for URS, IQ,OQ etc would be very much apprecoiated.
regards
Mike
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Mike Kilkelly
Quality & Regulatory Affairs Manager
Galway
Ireland
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