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Is DMSys fully GCP and 21 CFR Part 11 compliant?

April 26, 2017CFR compliant dmsys fully gcp

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Is DMSys fully GCP and 21 CFR Part 11 compliant?

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A. Yes. First, DMSys is fully validated. This does not simply mean that it has been thoroughly tested; its development has also been fully documented. Second, DMSys provides a complete audit trail. For any data entering the system through first data entry, verification (second data entry) or the data import function, an audit trail is maintained. Additionally, a full audit trail is maintained for any corrections and changes to data including the reason for making the correction.