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FDA 21 CFR Part 11 Compliance for Medical Device Companies



The US FDA has embraced digital signatures and online data storage for a long time. At first glance, compliance with FDA Part 11 regulations on electronic signatures and records seems straightforward. Yet many medical device and IVD companies unexpectedly raise the ire of the US FDA for not following specific requirements related to user access, audit trails, change control and system validation.

There’s Much More to “Electronic Signatures and Records” Than You Might Think.

Oriel STAT A MATRIX can help assess your current state of compliance with FDA 21 CFR Part 11 and make recommendations for changes. Ways we can help:

  • Assess how you currently store and protect your records and data through the lens of Part 11 compliance.
  • Recommend the right way to implement time stamped audit trails and user access management.
  • Review system documentation and training for people who use the system.
  • Evaluate your current digital signature process for FDA compliance.
  • Outline requirements for record retention and how to implement this.
  • Review of your change control procedures for compliance with Part 11.
  • How to validate your electronic records and signatures system (IQ, OQ and PQ).
  • Specific issues of Part 11 compliance related to clinical investigations.
  • Provide Training on Medical Device Data Integrity and 21 CFR Part 11 

Let Us Assess Your FDA Part 11 Compliance Gaps 

Part 11 applies to nearly all records associated with premarket submissions such as 510(k) and Premarket Approvals but also your Quality Management System records. As part of our gap analysis, we will show you which records must comply with Part 11 and where it is not required, along with detailed recommendations on how to comply.

The benefits of this assessment extend far beyond compliance with Part 11. Having a robust, validated document management system and electronic signature process will ensure the security of your data over the long run, reduce confusion over duplicate documents and improve operational workflows.

Contact Us for a proposal on how we can help you comply, assess, and achieve compliance with FDA 21 CFR Part 11.

Oriel STAT A MATRIX’s Goal

Help our life science customers meet regulatory requirements, boost efficiency, and improve patient outcomes

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