Simplify Processes to be More Compliant
Suppliers to pharmaceutical and medical device companies have to strike a balance between compliance for some customers while satisfying all the rest. It leads to complicated workflows and inconsistent control.
What if you could streamline your processes and improve compliance?
For one supplier of a critical component to both drug and device companies, that’s exactly what Cerulean helped them accomplish. Inconsistent application of FDA quality controls was leading to loss of business. And yet, if process controls were applied as their FDA-regulated customers wished, business workflows would gain too much overhead and cause immediate loss of company profitability.
One pharmaceutical customer recommended the supplier bring in Cerulean.
We streamlined the supplier’s overall workflows, fixed gaps without adding overhead, and simplified their quality system. The result was a quality system that met FDA and ISO 9001 compliance without added cost.
“We needed help to understand what our FDA-regulated customers wanted in relationship to our internal processes. And to do it all without breaking the success we had with non-FDA regulated customers. Cerulean’s John Avellanet came highly recommended. He reviewed our SOPs and polices and forms, and was a very quick study on the workflows within our business. He then simplified our processes and even negotiated closure, on our behalf, of the pharmaceutical firm’s supplier audit findings. And all along, Cerulean’s service was excellent. Tell anyone considering working with you to call me. Thank you again.”
– Mark Pope, President, Kennesaw, Georgia