Ensure your systems meet
21 CFR Part 11 requirements
Expert compliance support for accurate electronic records, electronic signatures and audit trails in FDA-regulated environments
Our proven testing process:
Review your system and identify Part 11 requirements that apply to your organization
Create a plan to align processes and technology with FDA rules
Let’s chat and see how we can help
Arbour Group 2025
(312) 207-5800
Validate electronic records and signatures for accuracy, security, and audit readiness
Provide complete documentation to prove compliance and support inspections
Why they prefer Arbour Group
Proven Compliance Expertise
FDA 21 CFR Part 11
EU Annex 11
GxP
Computer Software Assurance (CSA)
30+
Years of Assuring Life Science Compliance Solutions
Full Service Process
From initial assessment to ongoing support, with complete, audit-ready documentation every time.
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Ready to simplify your 21 CFR Part 11 compliance?
Arbour Group helps life sciences meet FDA electronic records and signature requirements with audit-ready documentation and proven compliance processes.
Pharmaceutical
Medical Device
Biotechnology
Diagnostic
Meet FDA and other global regulations to lower your compliance risks and protect your business.
Meet FDA, ISO 13485, and ISO 14971 requirements to reduce compliance risks for your medical devices.
Manage risks in developing and manufacturing drugs, vaccines, and antitoxins to protect your biotechnology business.
Develop reagents, instruments, and systems to diagnose, treat, and prevent disease in a fast-growing diagnostics market.
WHY US
INDUSTRIES WE SERVE
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