Challenge 

A global healthcare corporation needed to identify and execute several solutions for gaps in their design control system to ensure compliance with corporate and regulatory requirements.

SQL Solution

SQL addressed numerous gaps with the client’s design control system to establish root causes, corrective and preventive action (CAPA) plans, and effectiveness verification checks.  Specific gap-closure activities included procedure generation, training, Design History File (DHF) creation, and records review related to all aspects of design controls. 

Work involved interfacing with and engaging numerous site personnel having limited knowledge of regulatory regulations.  The project was further challenged with aggressive business priorities that competed with the same personnel and involved multiple sites. 

SQL was instrumental in closing these gaps through a unique blend of hands-on involvement, training through mentoring, and great flexibility.  Our collaboration and work with this client ensured they were capable of meeting regulatory and corporate requirements without impacting business objectives.