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
Note: These products are intended as client-configurable starting points