Title 21 CFR Part 11 of the Code of Federal Regulations outlines Federal Drug Administration (FDA) guidelines on electronic records and electronic signatures and the criteria that determine whether they are considered trustworthy and reliable. Pharmaceutical manufacturers, medical device manufacturers, biotech companies, biologics developers, and other FDA-regulated industries must comply with standards for their IT systems.

For a drug or other item regulated by the FDA to be GxP compliant, everything that contributes directly or indirectly to its development, manufacturing and handling must be GxP compliant. If you're in an FDA regulated business, that includes your information system.

Our experienced consultants know the ins and outs of these regulations and standards. They can help you develop processes and systems that keep you in compliance while reducing your administrative cost and cutting down on necessary paperwork.

To watch a free video on EntryPoint Consulting's approach to Global Trade, click here

For more information please contact our Partner and Vice President of Governance, Risk, and Compliance Dave Moore at (260) 417-1825 or by e-mailing dmoore@entrypointconsulting.com.