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Vitrex Medical A/S

“ The most important thing in a validation is to have a test protocol made, which you can test the systems according to. If you do not have specialists employed in software, it may be a challenge and it may be necessary to buy external consultants, but we were so lucky that we could use the standard protocol in D4InfoNet, ”says Peter Jørgensen, Quality & System manager.

Simpel validation with standard testprotokol

The test protocol is the most important thing to have in place when it comes to validating IT systems and software. Vitrex Medical A/S uses the standard version of D4InfoNet. “It describes in detail what to examine and test, and it also states what the expected result is. And then it’s just to verify that it matches reality, ”says Quality & System manager at Vitrex, Peter Jørgensen.

Why have you validated D4InfoNet?

As a medical equipment manufacturer, there is an EU legal requirement that we comply with the ISO 13485 standard. This implies, among other things, the validation of the software and IT equipment we use in our production and quality management. In this way, we can document that all processes work as they should and that we deliver products free from defects.We also produce for the United States, where the US Food and Drug Administration (FDA) requires validation.

How have you found the validation process to be?

The most important thing about validation is to have a test protocol made according to which you can test the systems. If you do not have specialists employed in software, it may be a challenge and you may need to buy external consultants, but we were so fortunate that we could use the standard protocol in D4InfoNet.

Part of the validation takes place at D4InfoNet, which hosts our solution and therefore takes care of the part that regards the server. We handle the user part ourselves and that is perfectly simple. The test protocol from D4 describes in detail what to check and test, and it also describes the expected result. And then it’s just about verifying that it matches reality.

What do you see as D4InfoNet’s greatest strengths?

We have spent two working days on the latest validation and it has been both simple and inexpensive in comparison to similar systems on the market. For example, this is because the standard test protocol and the simple setup do not require external consultants. An important aspect of our choice of D4 is that they have a good reputation and know our industry.

What are your best tips to ensure a good validation process?

Firstly, it must be made clear whether validation is at all a requirement from the authorities in the field in which you are working. Maybe it’s not necessary at all.

It is also important to carry out a careful risk assessment of your production and, on that basis, assess whether a test protocol such as the one in D4InfoNet can be used, or whether an external consultant should be brought in. There is no reason to invent the wheel if a workable protocol already exists.

“An important aspect of our choice of D4 is that they have a good reputation and know our industry”.

Vitrex develops, manufactures and sells a wide range of disposable equipment for the hospital and healthcare sector. The products include pipettes, test tubes and surgical tools, such as those used for diabetes treatment, intravenous treatment, blood sampling and surgeries. Vitrex delivers to markets all over the world – Europe, the United States, South America, Southeast Asia, the Middle East, Africa and Australia. The company was established in 1967 and the head office is in Herlev.

www.vitrexmedical.com

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