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