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.