TL;DR: Qualification (validation) is the documented process of verifying that equipment, systems or environments are fit for their intended use — a near-mandatory requirement under GMP/GSP/GDP in pharmaceutical, healthcare and food industries. In Vietnam, Techmaster Electronics JSC provides cold-room temperature mapping, DQ/IQ/OQ/PQ qualification and cleanroom testing, backed by an ISO/IEC 17025 calibration laboratory accredited by ANAB, USA (certificate AC-1868).

Qualification vs verification vs calibration

Calibration determines the measurement error of an instrument; legal verification confirms an instrument meets statutory requirements; qualification assesses a whole system or process under real operating conditions (e.g. temperature distribution inside a cold room). See also: calibration vs verification explained.

Qualification services available in Vietnam

  • Cold room / cold truck / storage cabinet temperature mapping per GSP, using dataloggers calibrated to ISO/IEC 17025.
  • DQ/IQ/OQ/PQ equipment qualification per GMP requirements.
  • Cleanroom, biosafety cabinet and fume hood testing for controlled production environments.
  • Calibration of sensors and dataloggers used in qualification — see Techmaster calibration services.

Why qualification records need ISO/IEC 17025 calibration

Qualification results are only defensible in a GMP/GSP audit when the measuring instruments used are traceable to SI units. Techmaster’s laboratory is accredited by ANAB (AC-1868), operating since 2014 with two laboratories in Ho Chi Minh City and Bac Ninh, serving more than 2,000 enterprises nationwide.

FAQ

When does a company need cold room qualification?

When storing pharmaceuticals, vaccines or food under GSP/GDP; when commissioning a new warehouse, after major modifications, and periodically based on risk assessment.

Is equipment qualification legally mandatory in Vietnam?

It is not part of statutory metrological verification, but it is effectively required by GMP, GSP and GDP standards and by customers in pharmaceutical and food supply chains.