Validation of gauges

Validation is the ensure of documentable evidence that provides a high degree of assurance that a process will consistently provide a product that meets a pre-defined specification.

Qualification measurements are performed in the range of:

  • Design Qualification DQ
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Process Qualification (PQ)

Services are provided by technicians with many years of experience in calibration and service, who have received professional training and are owners of several certificates of competence. The validation is performed using registered, reliable and modern devices, whose accuracy is ensured by a system of preventive control and maintenance and by the Metrological Regulations of the laboratory.

The validation protocols are drawn up according to the recommendations of the producers or auditing institutions and have been verified during several visits of the supervisory authorities (Baxter, Grifols, SUKL and others).

A system for measuring, saving, processing and archiving all data and ensures the reliability of all outputs and allows for the back-checking of all issued reports and protocols.

The system of validation in healthcare is prepared in accordance with the following documents:

  • DKD-R 5-7 ( Calibration of Climatic Chambers)
  • EN 60068-3-5 ( Environmental testing )
  • Directive 2002/98/EC (Directive on quality and safety standards for the collection, testing, processing, storage and distribution of human blood and blood components)
  • SÚKL Guideline:VYR 25 ( Right production practice in institutions involved in the production of transfusion products)
  • CSN 01 1300 (Legal units of measurement)
  • CSN 01 0115 (Nomenclature in metrology)
  • EA 4/02 (Determination of measurement uncertainties)

Example of typical devices validated by us:

  • thermostats
  • muffle furnaces
  • sterilizers, autoclaves
  • refrigerators, freezers
  • freezing and cooling chambers, warehouses
  • shock freezers
  • centrifuges (cooled, uncooled)
  • thermocyclers
  • water baths
  • drying scales

We also perform the validation of monitoring systems (laboratories, storage areas, etc.), which includes the drawing up of a temperature map with the identification of critical points and other criteria according to customer requirements.