Recent searches

No recent searches

FDA Compliance

Answered
image avatar

Servicio de Atención al Usuario

Posted Nov 07, 2023

Hello.

Has anyone created any FDA compliance document so far?

I'm starting one regarding requisites and privacy policy in line with those demanded in the health sector, but I'm sure this has been composed before.

Thank you.

 

 

0

4

4 comments

Date
    image avatar

    Ifra Saqlain

    Zendesk LuminaryMost Engaged Community Member - 2022Most Engaged Community Member of The Year - 2021Community Moderator

    Hi Carlos Piñeiro,

    I never made it FDA compliant but I can tell some points that will help you:

    • Clearly describe

                the issue.
                the path taken during the investigation.
                CAPA
                Conclusion

    • Prevent errors due to oral communications and informal documentations.
    • All GMP related operations

                 Manufacturing
                 Packaging
                 Testing, etc.

    • Investigation
    • Complaints
    • Have a conclusion
    • Be clear, consise and timely
    • Not assuming anything
    • Use charts, tables and graphs
    • Backup finding with evidence
    • Do not exaggerate
    • Outline the root cause
    • Timeine of investigation
    • etc.

     

    Hope this helps :)

    Thanks

     

    1

    image avatar

    Stephan Marzi

    Zendesk Luminary

    Sorry, this topic is handled by our compliance officers and other colleagues in the group/ enterprise.

    0

    image avatar

    Brandon Tidd

    Zendesk LuminaryUser Group LeaderThe Humblident Award - 2021Community Moderator

    Hi There - 

    These resources would be a good place to start:

    https://www.hhs.gov/hipaa/for-professionals/privacy/laws-regulations/index.html

    https://support.zendesk.com/hc/en-us/articles/4408832117786-Advanced-Compliance

    Brandon

    1

    image avatar

    Grace Maxon

    Customer Success

    Hi Carlos! 
     
    Thank you for your question and for reaching out! 
     
    While Zendesk provides tools for various industries, we don’t specifically comply with FDA Regulation 21 CFR Part 11. Instead, we focus on broader Security Compliance certifications. I recommend reviewing our SOC2 Report for gap assessment. The Advanced Compliance resource that Brandon provided is a great place to start, and I also recommend looking at our Trust Center. If you have further questions, I recommend reaching out to your Account Executive here at Zendesk for more information. 
     
    Thanks, and have a great day! 
    Grace

    1

    Please sign in to leave a comment.

    Didn't find what you're looking for?

    New post