Leading Provider of 21 CFR Part 11 Compliance

FDA Validation for Part 11. Trusted by Fortune 500 Companies.

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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.

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SEE WHAT OUR CLIENTS ARE SAYING ABOUT US

"The staff provided by Arbour Group have been skilled and well prepared to take on a variety of validation projects we have assigned to them. Their experience and expertise has helped enhance our validation assessment, planning and execution performance."

“Arbour Group has provided us with competent validation project leadership that has enabled us to complete projects in a timely and cost effective manner. The use of Arbour's validation product greatly facilitated the process.“

Vice President, IT at a Fortune 500 company

ARBOUR GROUP IS TRUSTED BY OVER 250 COMPANIES LIKE YOURS

Here are some of the pharmaceutical, medical device, and biotechnology companies we have worked with.

21 CFR Part 11 Assessments Focus on 6 Critical Areas

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.

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

WHY WE'RE BETTER

Arbour is dedicated to helping your organization raise quality levels, reduce costs, and increase shareholder value. We believe in a holistic approach to compliance, delivering extensive regulatory expertise and proven methodologies to help you achieve your goals.