Summary of Projects:

Clients Served:

• Agouron
• Alpha Therapeutic
• Alza
• Amylin
• Aviron
• Bioport
• ChemTrack
• Chiron
• Elan
• Elencor
• Gilead
• Glaxo Smith Kline
• Hoffman La Roche (Nutley R&D)
• Inhale Therapeutics
• Oread
• Pharmout Labs
• R. P. Scherer
• ScinoPharm
• Sequus
• Syntex
• Wyeth
• Yamanouchi Shaklee Pharma

Projects:

• QA Management Consulting
• IT Consulting
• Computer Validation Consulting
• Implementation & Validation of commercial LIMS systems in a variety of GXP laboratories
• Developmeny of a Computer Validation Department
• Development of Computer Validation SOPs
• Data Center and Network Qualification
• Developed IT Department SOPs
• MRP/ERP Validation
• Validation of Electronic Data Management (EDM) systems
• Design and Validation of Statistica based Annual Product Review (APR) System
• Developed and validated a variety of SAS-based data analysis systems (stability data, annual review data, etc.)
• Developed SOP's for system management, including security, change management, maintenance and administration
• Developed user-specific training manuals and department SOP's for using LIMS
• Developed technical specifications for a custom purchasing system
• Developed Requirements and RFP documents for LIMS selection
• Specification development and validation of an integrated, custom, call tracking and lab system
• Defined SOP's for operation of a custom GMP sample tracking system
• Audited LIMS and other GXP system vendors

Products:

• Model LIMS Validation Plan, IQ, OQ, and PQ Protocols
• SOP's for System Management, including security, maintenance, and change management
• Systems Vendor Audit SOP and checklist