Case Study: Multinational Pharmaceutical Corporation achieves 21 CFR Part 11 compliance with Arbour Group

Multinational Pharmaceutical Corporation - Customer Case Study

Multinational Pharmaceutical Corporation partnered with Arbour Group to address 21 CFR Part 11 compliance challenges amid rapid growth, major facility expansion, and increased automation. As the division scaled, senior management anticipated greater FDA scrutiny around electronic records and signatures, and needed a computer system master plan to bring critical legacy and new systems into compliance within one year.

Arbour Group supported the company by inventorying systems, assessing risk and compliance gaps, and developing a Part 11 remediation plan that prioritized high-, medium-, and low-risk systems by timeline. Arbour Group then worked with the client’s remediation team to correct selected high-priority systems, helping the division move toward compliance in time for its expansion.