regulations » 21 CFR Part 11 & Annex 11
FDA 21 CFR Part 11 & EU Annex 11 Compliance

Why implement a 21 CFR Part 11 and Annex 11 Compliant Software Solution?

The FDA requires life science companies to implement controls on the systems used to manage electronic records that are required by predicate rules or submitted to the FDA. Likewise, the European Medicine Agency (EMEA) requires similar controls for Annex 11 of the Medical Device Directive. 

At its core, InfoStrength is designed to be 21 CFR Part 11 and Annex 11 compliant. Not just so we are meeting regulations, but to help life science organizations effectively realize their informational values around data integrity, authenticity, nonrepudiation and security. These values are important to your Intellectual Property and confidential information, as well as your regulatory documents. 

FDA 21 CFR Part 11 & EU Annex 11 Compliance Solutions

Our combined solution of InfoStrength's software and our regulatory experts allow you to confidently manage your quality, manufacturing, business processes and much more, with document control, record retention and audit trails. 

InfoStrength supports 21 CFR Part 11 & Annex 11 compliance by:

  • Pre-validating the solution
  • Maintaining electronic records and their copies in auditable condition
  • Delivering audit reports designed for the auditor
  • Providing controls over content and its management
  • Limiting access to authorized individuals, while accelerating collaboration
Your InfoStrength solution delivers easier compliance, more efficient validation and improved process management. Why wait any longer? Contact us today to get started with your 21 CFR Part 11 software solution.