Developing and adhering to Design Controls provides the framework for Exceeding Customer Satisfaction and is equally applicable to both Regulated and Non-Regulated environments.
Instituting Design Controls is the start. Embracing, Owning and Executing Design Controls for the right reasons is the Path.
Refining these Design Controls through Lessons Learned, Audits and Customer Feedback is the road to Exceeding Customer Expectations and Satisfaction.
SEAS brings considerable experience tailoring the following controls specifically for your organization and organizational components.
· Planning
· Reviews
· Customer Needs
· Inputs
· Outputs
· Verification
· Validation
· Design Transfer
· Customer Support
· Complaint Handling
· Change and Release Management
· Design History and Device Master Record
· Quality Management (Document, Risk, Training, CAPA, Auditing)