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Is a Gap Analysis a necessary step to become 21 CFR Part11 compliant?

April 26, 2017CFR compliant gap analysis necessary step

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Is a Gap Analysis a necessary step to become 21 CFR Part11 compliant?

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A Gap Analysis is not a specified requirement of Part 11, however, during the process of becoming Part 11 compliant, most firms undergo a Gap Analysis as part of their assessment/remediation phase.