We use an efficient, systematic approach to protocol development which allows for preparation of the documentation in a minimal amount of time. We also employ a pragmatic, common sense approach to protocol execution which allows us to fulfill all regulatory requirements efficiently with a minimum of delay and a minimum of interference with operations.

• GAMP5
• Auditing Services
• Quality Plans
• Validation Master Plans
• IQ Protocol Generation & Implementation
• OQ Protocol Generation & Implementation
• PQ Protocol Generation & Implementation
• Summary Reports
• Computer System Validation
• Project Management
• SAT Generation & Implementation
• FAT Generation & Implementation
• SOP Development & Review
• Equipment/Process Specification
• URS Generation
• FRS Generation
• DDS Generation
• cGMP Training Courses