FDA 21 CFR Part 11: 7 Ways to Avoid Noncompliance

The FDA’s guidance for the creation and storage of electronic signatures and records as official documentation has held fast for 30 years. However, just like in the life sciences, breakthroughs in quality management software (QMS) continue to progress rapidly. It’s critical companies in the life sciences sector use digital solutions that help them remain competitive and avoid major setbacks that come from noncompliance. In “21 CFR Part 11: 7 Ways to Avoid Noncompliance” you’ll learn how to:

  • Side-step common compliance mistakes.
  • Easily share data with the FDA.
  • Simplify validation with cloud-based software.

How can a digital, cloud-based solution help you avoid Part 11 noncompliance?


Stay in Control of Your QMS

Empower your end users and system administrators with customisable access at the user, system, and document level. Keep your electronic records and signatures secure with unique passwords that can’t be duplicated by other users and get real-time notifications on suspicious login activity.


Give the FDA What They Need

Don’t dread in-person or hybrid audits. Keep paper out of the equation. Never lose track of document revisions and approvals again with automatically updated audit trails and customizable document archiving.


Do Risk-Based Software Validation

Keep your QMS running smoothly with cloud-based, validated software and risk-based validation templates and tools. Pinpoint major areas of risk instead of wasting resources combing through everything and be confident that each software release keeps you compliant.

Are You Ready for a Quality System That Stays Compliant?

Say goodbye to 21 CFR Part 11 noncompliance with these guidelines.

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