Validation: who does what
The line between supplier, customer and third party, explained without jargon. And why it matters to have it in place before the work starts.
Who carries out the validation?
We do, on our own or in close cooperation with your QA. Validation is documented confirmation that the system does what you use it for, in your environment and with your setup. In other words, it is your use that is validated, not the product, and that is why you define the scope. We take on the work itself.
The division in practice: you define the requirements and scope based on your risk assessment and SOPs, and approve the plan. We supply the system and the documentation and carry out IQ, OQ and PQ. That includes functional descriptions, calibration certificates, installation checks and supplier information.
If you would rather handle it yourselves, or use an external consultant, you can. Then we supply the system and the complete documentation package, and take part in the clarification. We mainly see this in pharma, while hospitals typically have us handle the whole process.
If you have not done it before, it is worth clarifying the roles before the project starts. It is the most common source of delay.
The roles in a validation process
The supplier
Supplies the system, the documentation and the validation: functional descriptions, certificates, installation checks, supplier information and IQ, OQ and PQ.
The customer
Defines the scope based on a risk assessment and approves the plan. Responsibility for the validation being completed lies with you, but we do the work.
The third party
An external consultant who can do the work on the customer's behalf if there are no resources or experience in-house.
The validation plan
Describes what is validated, how, and who does what. Agreed before the work starts.
IQ, OQ and PQ
Installation, operation and performance. Three steps that document that the system is set up correctly and works as intended.
Revalidation
After significant changes to setup, software or use, parts of the validation must be repeated.
What the validation consists of
Validation plan, requirements specification, functional specification, equipment standard, parameter list, alarm call-out specification, traceability matrix, document overview, installation check, functional check and instructions. We prepare the material and carry out the checks, and you approve along the way.
Frequently asked questions
Can you validate the system for us?
Yes. We carry out the validation, on our own or in close cooperation with your QA. You define the scope, because it is your use that is being validated, but we take on the work itself.
What are IQ, OQ and PQ?
Installation Qualification confirms that the system is installed correctly. Operational Qualification that it works as specified. Performance Qualification that it works in your day-to-day operation.
How large should the scope be?
It follows from your risk assessment. Critical measuring points are typically validated more thoroughly than less critical ones, and we advise on where the line sensibly goes.
Do we have to validate again after an update?
After significant changes, yes. If the system runs on-premises, you decide yourselves when to update.
Can you recommend a consultant?
We can point out what needs to be clarified and what kind of expertise is needed. The choice is yours.
De bruger os allerede
Kom hurtigt i kontakt med den rette specialist.
Vi hjælper med alt fra nye monitoreringsløsninger til kalibrering, validering og teknisk support.
Generelle henvendelser
Nye projekter
IT & teknik
Administration
Besøg os
Måløv Byvej 229
2760 Måløv
Ring til os
+45 72 22 02 05
Man-fre, 08-16
Fortæl os, hvad du har brug for.
Vil du se, hvordan det ser ud hos jer?
Book en gennemgang. Vi kommer forbi, ser på udstyr og lokaler og rådgiver om, hvor følerne skal sidde. Derefter får du et skræddersyet forslag. Uden forpligtelser.
Book en gennemgang