FDA compliance made simple
Life Sciences expertise, warranted deliverables and pre-packed validation solutions for SAP, Oracle/NetSuite, Microsoft Dynamics, Infor, and other enterprise software.
Our proven testing process:
Assess your system to identify regulatory functional requirements
Develop test scripts that prove accuracy of quality records
Let’s chat and see how we can help
Arbour Group 2025
(312) 207-5800
Execute testing, resolve non-conformances and document results
Summarize testing and assemble documentation
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 assessment to retesting, with complete, audit-ready documentation every time.
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Ready to get started with software validation?
Arbour Group helps life sciences test and document their software so it meets FDA, EU Annex 11, and other international guidelines.
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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