When one of our clients struggled with enough talent to fulfill a broad remediation plan they promised the FDA, they turned to Compliance Architects®. After quickly scoping their needs and factoring in the company’s “personality” we were able to select the perfect individual to work hand-in-hand with their staff. In short order our colleague provided the following:
- Represented their needs, requirements, and objectives in the workstreams for deviation management, CAPA and change control.
- Reviewed and provided invaluable feedback on workstream outputs, including standard operating procedures, metrics, and their training material.
- Provided updates to program leadership regarding the delivery plans and schedule for these workstreams and helped program leadership evaluate how well requirements and objectives were being met.
- Supported executive leadership with establishing and maintaining appropriate governance forums (e.g., CAPA Review Board), and supporting activities related to these forums.