Rapid FDA Recordkeeping

Rapid FDA Recordkeeping

FDA is citing firms more and more for inadequate recordkeeping and record retention. From electronic recordkeeping systems to all paper to a hybrid reality, firms need to manage their documents and emails and records to ensure compliance without risking greater liability and causing greater cost. “Keeping everything” is no solution – and going it alone is fraught with pitfalls.

A major food company in the US Midwest brought in Cerulean to help them implement a top tier FDA recordkeeping program with streamlined policies and realistic records retention schedules.  Here’s what the chair of their records management department had to say:

“We selected Cerulean Associates because of their level of experience, credibility, and specifically their expertise with FDA, manufacturing and records. Their work really helped our executive team see the need for good recordkeeping, put in place a straightforward compliant framework, and provide definitions and examples that answered all our questions – and that we refer to even today.  John Avellanet of Cerulean is a no-nonsense expert and will help any company achieve rapid results in the most cost-effective way possible.”

– Luanne Lochner, Records Management Chair, Baraboo, Wisconsin

 If you need an FDA recordkeeping expert to help you put in a simple, cost-effective, realistic records management program you can live with – and rely upon – contact Cerulean today. We can give you options from onsite corporate training to streamlining your current recordkeeping schedule to a turnkey program implementation … whatever works best for you.

Make FDA recordkeeping easy and call Cerulean today