Security

EnterpriseWizard Compliance With CFR 21 Part 11

Download Now Free registration required

Executive Summary

Almost all industries depend upon software for the efficient, auditable and reliable execution of their business processes. For most companies subject to FDA regulation, this requires compliance with CFR 21 Part 11 if these processes involve the use of electronic signatures on data required to be maintained by the FDA predicate rule or used to demonstrate compliance with such a rule. This paper provides an overview of the rule and describes how EnterpriseWizard supports it.

  • Format: PDF
  • Size: 375.9 KB