5 Ways to Ensure System Compliance with 21 CFR Part 11

 

Under 21 CFR Part 11, FDA-regulated companies that maintain electronic records to meet predicate rules are also required to validate their electronic record-keeping systems. The following White Paper, 5 Ways to Ensure System Compliance with 21 CFR Part 11 offers tips to strengthen your validation documentation and help ensure Part 11 compliance.

Watch Related Videos



Downloads:

White Paper:
5 Ways to Ensure System Compliance with 21 CFR Part 11

White Paper:
21 CFR Part 11 - Are You Ready for an FDA Inspection?
White Paper:
21 CFR Part 11 Computer Systems Validation (Risk Mgmt. Plan)
White Paper:
21 CFR Part 11 Risk of Noncompliance

White Paper:
21 CFR Part 11 MasterControl Product Positioning




Additional Resources:

View all available resources?

DOCUMENTS
Product Data Sheets
White Papers
Q&As
Tech Papers
Case Studies
ONLINE RESOURCES
Online Demonstrations
Webinars