This website uses cookies ...but have cookies ;-)


For an optimal website experience, we use cookies and similar technologies to show personalized content, offer functions and collect statistics. Clicking on "Allow cookies" entitles us to this data processing in accordance with our data protection declaration . Cookies can also be adjusted at any time after selection (after clicking on the item at the top right) in the settings.

Essential cookies enable basic functions and are necessary for the website to function properly.
Statistics cookies collect information anonymously. This information helps us to understand how our visitors use our website.
Marketing cookies are used by third parties or publishers to display personalized advertisements. They do this by tracking visitors across websites.

Ortners Qualification Method is Always Prospective

The qualification is usually carried out together with the customer. Depending on the respective requirements of the customer, the qualification depth on the part of Ortner- i.e. the share of the entire qualification project to be provided by Ortner- can vary.

Basically, 3 categories of qualification depth can be distinguished.

Category 1

  • Ortner provides documentation for the DQ (schematics, data sheets, component list, spare parts list, functional description, certificates, etc.) and performs the commissioning. A FAT or SAT is not made.

Category 1

  • The customer plans the entire qualification and carries it out on his own responsibility. (Preparation of risk analyses, DQ, IQ, OQ test plans and execution of the tests). The scope and quality of the documents to be delivered by Ortner is to be defined in the QPP.
Graphical representation of the individual elements of a qualification.

Category 2

  • Ortner provides documentation for the DQ (schematics, data sheets, component list, spare parts list, functional description, certificates, etc.), prepares a FAT and/or SAT plan and performs the FAT, SAT and commissioning. For simple plants or plants delivered in assemblies, the FAT is not required.

Category 2

  • The customer plans the entire qualification and carries it out on his own responsibility. (The FAT/ SAT plans of Ortner are prepared in accordance with GMP and can serve as "raw data", so to speak, for the qualification team of the CL). The scope and quality of the documents to be delivered by Ortner is defined in the QPP.
Graphical representation of the individual elements of a qualification.

Category 3

  • Ortner prepares the corresponding specification documents (plans, risk analysis, etc.) and carries out the qualification on its own responsibility until the end of the OQ. Depending on the scope and delivery condition of the plant, FAT and/ or SAT can be omitted, the determination is made with the customer in the QPP.

Category 3

  • The customer is responsible for the DQ. He incorporates the completed qualification directly into his quality system and, if necessary, continues with the PQ. The documents are specified in the QPP.
Graphical representation of the individual elements of a qualification.
Close the window