Qualification & Validation

ASCENT extends its capability in the area of validation business and is focused to cater life science industry domain with a primary focus in Computer System Validation, 21 CFR Part 11 compliances. We have executed Validation activities for Stand-alone PLCs, DCS, Control System for HVAC & Laboratory equipments.

We undertake Validation of Control Systems (CSV). We assist you in preparing DQ, IQ, and OQ & PQ protocols & can execute them on need basis. We help you in meeting 21 CFR Part 11 compliances for control system.

Typical deliverables include -

  • Qualification Protocol Development
  • Traceability matrix
  • Protocol execution
  • Summary reports
  • Ongoing compliance programs for Validation & 21 CFR Part 11