
IT Project Management
Lean Biologix incorporates the ISPE GAMP 5 process for IT projects. We have extensive expertise creating and working with System Development Lifecycle Documentation (SDLC):
- User Requirements Specifications (URS)
- Functional Specifications (FS)
- Design Specifications (DS)
- Traceability Matrix documents (TM)
As well as:
- Risk Assessments
- Data Migration Plans
- System Impact Assessments
Lean Biologix also has expertise in IT change management:
- Authoring and executing test script (HP ALM or paper based)
- Change control reporting and approval routing
- Data integrity requirements
- System auditing and compliance requirements.