Industry: Pharmaceuticals
Service: 21 CFR Part 11 Compliance
Background The division had experienced rapid growth in recent years. This growth required the division to significantly expand its facilities and substantially increase automation to support this increased level of business.
Business Issue Senior management anticipated increased regulatory scrutiny associated with the expansion in manufacturing, especially in light of recent FDA requirements regarding electronic records and signatures.
The Objective The division had to develop a computer system master plan and begin bringing its systems into compliance. All high priority legacy systems and new systems supporting the expansion had to be compliant within one year.
The Solution Arbour Group worked with the company's senior management to inventory systems, assess risk, assess compliance gaps and develop a Part 11 remediation plan. This plan identified time frames for bringing high-, medium- and low-risk systems into compliance. Arbour Group experts then worked with the client's Part 11 remediation group to rectify selected high priority systems.