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.
Our Clients
Organogenesis
Canton, Massachusetts
Projects Completed
- Developed URS and FRS documentation for automated tissue culture processing equipment
- Assisted with system startup and troubleshooting
References
- Ted Donahue (Automation Engineer)
Organogenesis
Canton, Massachusetts
Projects Completed
- Qualified (IQ, OQ, PQ) a new autoclave
References
- Paul Strouth (Validation Engineer)
Genzyme
Framingham, Massachusetts
Projects Completed
- Qualified (IQ and OQ) Pall automatic Filter Integrity Testers
References
- Denise Connelly (Validation Manager)
Genzyme
Framingham, Massachusetts
Projects Completed
- Qualified new and upgraded Validator 2000 dataloggers to software version 2.33
References
- Denise Connelly (Validation Manager)
Genzyme
Framingham, Massachusetts
Projects Completed
- Requalified Autoclave loads
- Requalified Depyrogenation Oven loads
- Qualified new Autoclave loads
References
- Joe Baumann (Senior Director of Validation)
Genzyme
Framingham, Massachusetts
Projects Completed
- Environmental Chamber Qualification (IQ and OQ)
References
- John Zurheide (Validation Manager)
Genzyme
Framingham, Massachusetts
Projects Completed
- Requalified Cold and Warm Rooms
- Requalified Temperature Controlled Warehouse
References
- John Zurheide (Validation Manager)
Lonza Biologics
Portsmouth, NH
Projects Completed
- Commissioning and Operational Qualification of a new 20K Cell Culture Train
- SIP and CIP qualification of a new 20L Cell Culture Train
- Qualified critical utility (WFI, clean compressed air, speciality gas) expansions for a new 20K Cell Culture Train
References
- Dan Milewski (Validation Project Manager)
Lonza Biologics
Portsmouth, NH
Projects Completed
- Qualified operation of a new 20K Cell Culture Train
- Qualified SIP and CIP for a new 20K Cell Culture Train
- Qualified critical utilities (WFI, clean compressed air, specialty gases) for a new 20K Cell Culture train
References
- Karen Wiseman (Senior Project Engineer)
Advanced Cell Technology
Worcester, Massachusetts
Projects Completed
- Qualified Controlled Temperature Units (CTUs), Biosafety Cabinets and other Clinical Production equipment for a stem cell Clinical Manufacuring laboratory
- Qualified HVAC subsystem serving a Clinical Manufacuring laboratory
References
- Linda Lemieux (Director, QA/QC)
Eisai Research Institute
Andover, Massachusetts
Projects Completed
- Qualified CTUs for a GMP Warehouse expansion
References
- Randy Earle (Validation Engineer)