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.