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Systems validation according to Regulation (EU) 2017/746

As part of the Regulatory department at a medical device manufacturing company and according to  Regulation (EU) 2017/746 we are required to validate the systems we daily use during the company's product development.

 

I wondered if besides the technical information I have found based on the cloud's security compliance of the cloud there would be any kind of information/documentation Atlassian would be able to share to facilitate the PQ/OQ/IQ validation we are planning on carrying out on our own.

 

Thank you!

1 answer

1 vote

We have not yet evaluated for EU 2017/746, however, we recently aligned our practices with HIPAA, which is a US medical data framework. It might be similar enough to help with your evaluation. Please see : https://www.atlassian.com/trust/compliance/resources/hipaa 

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