Design Documentation
OEM Equipment Manuals
- Mechanical Engineering Drawings
- Electrical Schematics
- Pneumatic Schematics
- Operational Procedures
- Spare Parts and Bill of Material Lists
FDA Validation Packages
- Functional Design Specifications
- Configuration Specifications
- Software Design Specifications
- pFEMA
- FAT/SAT Protocols
- Trace Matrix
Sytem Development
TSR Solutions has adopted ISPE's GAMP 5 as our guideline for development of Manufacturing Systems and Equipment. It is imperative with the FDA's 21st Century initiative that we maintain a risk-based approach to delivering compliant systems. Shown above is the standard GAMP "V" model as reference for Specification and Verification.