Arbour Group
Delivers software assurance and validation services for compliance with FDA and EU regulations in life sciences, aiding pharmaceutical, medical device, biotechnology, and diagnostic sectors.
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Overview
Arbour Group specializes in providing software assurance and lean validation and verification services that streamline compliance processes for life sciences companies. With over 25 years of experience, they support organizations in meeting FDA 21 CFR Part 11 and EU Annex 11 requirements.
Industries Served:
- Pharmaceutical: Assists in managing business risks related to compliance with FDA and international regulatory standards.
- Medical Device: Offers compliance support for FDA requirements and ISO standards, including ISO 13485 for Quality Management Systems and ISO 14971 for Risk Management.
- Biotechnology: Provides risk management assistance for the development and manufacture of drugs, vaccines, and antitoxins.
- Diagnostic: Supports companies in developing reagents, instruments, and systems for disease diagnosis, mitigation, treatment, or prevention.
Tools
Dynamics 365 Business Central
A cloud-based ERP solution for small to mid-sized businesses, integrating core processes to drive growth, reduce costs, and optimize decision-making.
NetSuite
Cloud-based ERP validation solution for life sciences ensuring compliance with domestic and international regulations.
Oracle ERP Cloud
A pre-packaged validation solution for Oracle ERP Cloud tailored for life sciences, ensuring compliance with regulatory standards.