How Does 21 CFR Part 11 Compliance Apply to eCTD Publishing Tools

In my document management career, my company provided specialized EDMS solutions for Pharma (for submissions, SOPs, trial master files, etc.). It was a given that these systems needed to be Part 11 compliant, and I authored our position paper on how Part 11 compliance was achieved and demonstrated in our product. If our product had ever been viewed as being noncompliant, no one would buy it – end of story. For whatever reason, few...

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