EAST COAST VALIDATION SERVICES, LLC is a Validation, Project Management, and Validation Maintenance Systems service company serving the Biotech and Pharmaceutical industries.

Founded in 2005, East Coast has over twenty years experience in GMP operations which enables us to provide high quality, cost effective service to industries regulated by the FDA.

Document Downloads

Guidelines and Regulations

The FDA's Paul Motise showed this at a PDA meeting a few years ago. It's one of the best illustrations I've ever seen of the difference between Guidelines and Regulations in the GMP world.

Validation Continuum

I've found this diagram to be helpful in understanding the overall Validation process and how the different efforts are related.