Source: https://www.arbourgroup.com/services/validation-compliance/21-cfr-part-11-compliance/
Timestamp: 2017-06-28 10:27:25
Document Index: 468875844

Matched Legal Cases: ['art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11']

FDA 21 CFR Part 11 Compliance Assessment | Arbour Group
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.
21 CFR Part 11 assessments focus on six 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.
Name Email Product / Service How can we help you? Case Study