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:
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.
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.
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.
Say goodbye to 21 CFR Part 11 noncompliance with these guidelines.Get Your Free Industry Brief