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QMS (Quality management system) for medical device development

5 comments

  • Spot On! ๐Ÿ‘ Innovative Approach ๐Ÿ’ก Stellar Advice ๐Ÿ’ช
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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 email us at support@team.wrike.com 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.ย 

    Stephanie Westbrook Community Team at Wrike ๐ŸŒŽDiscover... Wrike Discover and become a Wrike expert. Click here to get started

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    Tatiana Korogodina

    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.ย 

    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 4.2.5ย requires to protect healthย 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.ย 

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

    ย 

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    Coilin Walsh

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

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    Carolin Mohr

    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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  • Spot On! ๐Ÿ‘ Innovative Approach ๐Ÿ’ก Stellar Advice ๐Ÿ’ช
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    Lisa

    Hi Carolin Mohr, thanks for reaching out ๐Ÿ™‚ Your Account Manager will reach out to you about this ๐Ÿ‘

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

    Lisa Community Team at Wrike ๐ŸŒŽDiscover... Wrike Discover and become a Wrike expert. Click here to get started

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