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LO1 Tracker

Typical Engagements

Industry Related Experience

Program/Project Management

Qualified Resources






Pharmaceuticals, Medical Device, and
Biotechnology Industry Experience

  • Program & Project Management

  • Computer System Validation (CSV)

  • Commissioning, Qualification and Process Validation

  • 21 CFR Part 11 Validation

  • QSR, GxP, ICH, EMEA, MDD, ISO, GAMP 5 and other regulatory compliance standards

  • Business Process Re-engineering (BPR)

  • Facility Commissioning and Qualification

  • Document Control and Knowledge Management

  • Custom Software, Database Design, Development, and Documentation

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