Instrument Qualification

Consider it done.

For customers working in a GXP environment, we offer an integrated qualification process and protocols for all your equipment, independent of brand.

This metrology-based qualification process has a proven track record of compliance with all FDA requirements, as well as other regulating authorities.

Our qualification strategy will greatly benefit you by reducing the process of review, auditing and archiving of documentation.

We create a custom made qualification binder to suit your exact system configuration and specifications with protocols and calibration certificates.

IQ/OQ/

  • Standard operating procedure ready to go
  • Flexible acceptance criteria
  • GXP compliance (X= Laboratory, Manufacturing, Documentation, Regulatory, etc.)
  • NIST Traceable
  • Quality assurance support
  • Harmonized procedures
  • Electronic raw data
  • Traceable reference standards