QMS (Quality management system) for medical device development

We are thinking about using Wrike as a part of our QMS (Quality management system) for medical device development according to  ISO13485:2016. Have anyone to your knowledge validated your software for this? If not would you be interested in the results of our validation and user story when using it for medical device development?

For validation we will be using paragraph 4.2.5 & 4.1.6 in ISO13485:2016 standard.

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Stephanie Westbrook

Hi Per, glad to hear you guys are evaluating Wrike! We haven't done an assessment for that ISO standard. Feel free to contact Wrike Support here if there's something you would like to share. Since you guys are getting set up, let me know if there's any product/set up questions you have that we could help with. 

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Hi Per

thank you for starting this discussion!

I' d like to share my considerations on that:

as ISO recommends 4.1.6 Approach for software (re)validation shall be proportionate to the risk associated with the use of the software. Could you share your considerations about the risks related to the Wrike use for task/project management?

I'm working at CRO, and have started Wrike free trial. My considerations are that no validation is needed as far as we do not use Wtike to create/maintain/archive any documentation defined in predicate rules (e.g. CFR, GCP). We also discussed internaly w/ou DM team and concluded that the using Wrike to the extent of task management in line with paper study file (TMF) is like using Outlook or MS Word, and shall be managed according to the SOP for this kind of software. 

My understanding is that ISO requirements about the softaware you are using in the device production, testing, etc. and about electronic records related to production and testing.

And 4.2.5 requires to protect health information contained in records. So, if we do not use Wrike to transmit or produce health information, there is no risk related to confidentiality of the information. 

Also at Wrike Terms and Conditions you can fina a link to the security certification and information related to the license for use.    

 

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Thanks for starting this thread, Per. Stephanie, have you done an assessment with ISO 9001 and/or ISO 17025?

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Hey there, we would also like to use WRIKE as a project management tool for managing the task management of medical development projects according to DIN ISO 13485: 2016. We are not sure if we need to validate. Does any of you have a reference to a guideline that can be used to justify non-validation? The statement that we interpret WRIKE as an auxiliary tool such as Word, Outlook etc. will hardly suffice as confirmation for the auditor. I thank you already for the help.

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Hi Carolin Mohr, thanks for reaching out 🙂 Your Account Manager will reach out to you about this 👍

It will also be great if our Community members with similar experience could share something on the topic.

Lisa Community Team at Wrike Wrike Product Manager Become a Wrike expert with Wrike Discover

Lisa Wrike Team member Become a Wrike expert with Wrike Discover

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Hi there, if this topic is still alive I would greatly appreciate any feedback from your expériences. I'm looking for the same thing, using Wrike to support my ISO 13485 QMS.

any good advice ?

 

 

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Hi @Sébastien Moreau, welcome to the forums! 🙂

I'm hoping someone will reach out here. I can also ask your Account Manager to reach out to you about this if you'd like - please let me know 👍

 

Lisa Community Team at Wrike Wrike Product Manager Become a Wrike expert with Wrike Discover

Lisa Wrike Team member Become a Wrike expert with Wrike Discover

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Dear Sebastien,

Yes, the topic is current with us. Since there is no clear definition in ISO 13485 of the need for computer validation for administrative tools such as Outlook, MS Project and the like, we have conducted a documented User Acceptance Test (IQ, UAT report, UAT protocol). In doing so, we addressed the significant core processes such as changes to documents (versioning) and comments etc. and were able to prove the expected result. This is a special case for Wrike in the context of the 13485, which is why there is no documentation directly from Wrike. I hope this helps you further.

Best regards

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Would anyone care to update their experiences on this? It seems that some users are using the software for QMS related activities which would require some validation, and others are using it more for project management only with no validation. If this assessment is correct, can anyone provide a more formal justification on the decision to validate based on what the software is/isn't doing?

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Hi Benjamin Lies, welcome to the Community! 

Our Support team is in touch with you via email regarding your question here. Please let me know if I can help you with anything else 🙋🏻‍♀️

Cansu Community Team at Wrike Wrike Product Manager Become a Wrike expert with Wrike Discover

Cansu Wrike Team member Become a Wrike expert with Wrike Discover

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Hi Benjamin, 

I mentioned above in my comment that we only use Wrike as an organizational tool in the context of project management and therefore validation is not necessary. Therefore, I can't give you any tips on validating Wrike. This is also difficult, because Wrike is constantly evolving in an uncontrolled way and we don't have a test system. We have documented functional tests for what we consider to be the most important functions. So far, we have not received any request for validation from the notified bodies in the course of audits. But that also depends on the particular use case and what records you want to use Wrike for. I hope this helps you.

Best regards 🙂

Carolin

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