https://www.ofnisystems.com/warning-letter-no-validation-for-software-revisions-ucm574774/
Warning Letter: No validation for software revisions (ucm574774) | Ofni Systems
Sep 20, 2017 - Specifically, there are no written purchasing control procedures; no requirements, including quality requirements have been established for your suppliers; and...
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https://www.ofnisystems.com/tag/computer-system/page/8/
Computer System Archives - Page 8 of 14 - Ofni Systems
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https://www.ofnisystems.com/blog/page/2/
Compliance Blog Archives - Page 2 of 2 - Ofni Systems
Ofni Systems' blog of various issues relating to electronic record compliance, validation and clinical management.
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https://www.ofnisystems.com/warning-letter-no-verification-of-the-accuracy-of-excel-spreadsheets-ucm-311326/
Warning Letter: Lack of spreadsheet controls (UCM 311326) | Ofni Systems
Oct 19, 2016 - Specific violations observed during the inspection include, but are not limited, to the following: Your firm has not established designed to assure that...
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https://www.ofnisystems.com/tag/database/
Database Archives - Ofni Systems
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