Having a significant backlog of CAPAs across 3 manufacturing sites and the home office is a huge red flag for the FDA. But that’s what a client had when they called us and asked for help. Tapping into out talent database, Compliance Architects® was able to quickly pull together a CAPA support squad to help this client get back on track. Our experts made sure to:
- Drive individual CAPAs to completion at each of the three manufacturing sites and home office.
- Rationalize CAPAs that were initiated against other structured, documented programs, to identify and correct redundancies.
- Assist individuals and teams to get CAPAs driven to completion, and to help bring the numbers of open CAPAs to acceptable levels going forward.