(312) 207-5800

Arbour Group 21 CFR Part 11 assessment and remediation services are designed to help clients ensure that electronic records and electronic signatures are trustworthy, reliable, generally equivalent substitutes for paper records and traditional handwritten signatures, and that those functions are in conformance with the requirements of 21 CFR Part 11 compliance.

Experience That’s Second to None

Arbour Group's experienced professionals are extensively trained to evaluate a client's use and documentation of electronic records and electronic signatures as governed by applicable regulatory requirements. The result of a 21 CFR Part 11 assessment determines the effectiveness of a client's process within a highly regulated environment and suggests appropriate remedial actions as necessary.

Why We’re Better

21 CFR Part 11 assessments focus on six critical areas:

  • Impact of 21 CFR Part 11 on the client's computer systems
  • Identification of the client's computer systems and operating environment
  • Hosting and interpretation of user interviews
  • Review and consideration of client procedures
  • Analysis of procedural documentation, validation and audit data
  • Regulatory significance of the computer systems

With these six areas being the focal point of our assessment, Arbour Group is able to give our client’s an in-depth and thorough inspection of their systems and procedures that is unmatched. We ensure compliance with the requirements of 21 CFR Part 11 through our years of experience and solutions that are unique to you and your company's needs.

The Arbour Advantage

Arbour Group is a trusted advisor to over 250 pharmaceutical, medical device and biotechnology companies worldwide. Let us demonstrate how we can integrate seamlessly into your organization, prove ourselves a valuable business partner and deliver effective services that reduce compliance costs.

 

WHAT OUR CLIENTS THINK