Specialization · GAMP 5

Validation (CSV)

Computer Systems Validation, equipment qualification, and IQ/OQ/PQ leadership for GxP environments.

Core Capabilities

What our placed engineers do daily.

  • GAMP 5 lifecycle authorship — URS, FRS, DS, IQ, OQ, PQ
  • 21 CFR Part 11 compliance assessments and remediation
  • Equipment qualification: autoclaves, lyophilizers, isolators, HVAC
  • Empower 3, LIMS, MES, and SCADA validation
  • Periodic review, change control, and validation master plans
  • Data integrity (ALCOA+) audits and gap remediation
FAQ

Frequently Asked Questions

We place CSV (Computer System Validation) Engineers, Process Validation Scientists, Equipment Qualification Specialists (IQ/OQ/PQ), Cleaning Validation Engineers, and Method Validation Analysts across pharma and biotech sites in the NY/NJ corridor.