CSV Related Links

• FDA Web Site for 21 CFR Part 11
• FDA Compliance Policy Guide ( CPG 7153.17)
• Computerized Systems Used in Clinical Trials (Guidance for industry)

Articles of Interest

• Regulatory Beat: FDA Moves to Streamline GMP Inspections. Taken from Bio Pharm International Magazine, June 1, 2007.
• Risk-Based Equipment Qualification: A User/Supplier Cooperative Approach
• Outsourcing and Contract Manufacturing on the Pharmaceutical Industry
• RFID yes, UPC no and probably not
• Wireless reliability in industrial automation
• Computer Validation Master Planning
• Pharmaceutical cGMPs for the 21st Century - A Risk Based Approach. Final Report from the U.S. Food and Drug Administration, September 2004
• Guidance for Industry - Q9 Quality Risk Management from the U.S. Food and Drug Administration, June 2006

Industry Links

• AICHE
• ASME
• Control Magazine
• FDA
• GAMP
• ISA
• ISA Automation Standards
• ISPE
• World Batch Forum
• Control System Integrators Association

Collaborators

• Aireko Management Services (AMS)
• Bermudez & Long/Diaz-Masso
• Caribbean Industrial Construction (CIC)
• Caribbean Project Managers (CPM)
• CMA Architects & Engineers
• Cornerstone Controls
• Emerson Process Management
• Fluor
• Jacobs
• Johnson Controls
• Pharmadule
• Rockwell Automation
• UNIPRO Architects, Engineers & Planners

Supplier Links

• ABB
• Acopian
• Ametek Drexelbrook
• Aspen Technologies
• Autodesk
• Brooks Instrument
• Cisco
• Danfoss
• Emerson Process Management
• Endress + Hauser
• EPLAN
• Expertune
• Flowserve
• GE Fanuc
• GE Panametrics
• General Monitors
• Hach
• Hammond Manufacturing
• Hoffman Engineering
• Hoke
• Honeywell
• IBM Maximo
• Intergraph
• Invensys Process Systems
• Krohne
• K-TEK
• Limitorque
• Magnetrol
• Masoneilan
• Metso Automation
• Mettler Toledo
• Moore Industries
• MSA
• MTL
• Ohmart Vega
• Parker-Hannifin
• Pepperl + Fuchs
• Phoenix Contact
• Rittal
• Rockwell Automation
• Ronan Engineering
• Rotork Controls
• Samson Controls
• Schneider Electric
• Siemens
• SolaHD
• Swagelok
• Thermo Scientific
• TiPS
• Tyco Flow Control
• Vaisala
• Weidmuller
• Yokogawa