General Discussions

Has anyone gone through or experienced a FDA Inspection/Survey? How did you showcase Cayuse HE to the inspector, narrowed which studies were FDA studies, etc? Did you download everything on a flashdrive drive for them? Provided them a Cayuse account?

Having asked my colleagues, the recommendations center around giving the auditor specifically what they ask for via printed materials or PDFs on a flash drive, rather than giving blanket access.  This keeps the focus solely on the requested information.  If you're using flags, flagged FDA studies can be identified via reporting.

Has anyone gone through or experienced a FDA Inspection/Survey? How did you showcase Cayuse HE to the inspector, narrowed which studies were FDA studies, etc? Did you download everything on a flashdrive drive for them? Provided them a Cayuse account?

Can you explain how flags work? I would love to implement those, but have never seen them in Cayuse HE.

Having asked my colleagues, the recommendations center around giving the auditor specifically what they ask for via printed materials or PDFs on a flash drive, rather than giving blanket access.  This keeps the focus solely on the requested information.  If you're using flags, flagged FDA studies can be identified via reporting.

Has anyone gone through or experienced a FDA Inspection/Survey? How did you showcase Cayuse HE to the inspector, narrowed which studies were FDA studies, etc? Did you download everything on a flashdrive drive for them? Provided them a Cayuse account?

Can you explain how flags work? I would love to implement those, but have never seen them in Cayuse HE.

------------------------------
Daniel R. Kirienko, Ph.D.
Preferred pronouns: he, him, his
IRB Compliance Lead
Office of Research Integrity
Rice University| 350 Allen Center | 6100 Main Street, MS 16 | Houston, TX 77005
Tel: 713.348.3586
dk32@rice.edu

Original Message:
Sent: 05-26-2023 07:03
From: MK Karafonda
Subject: FDA Inspection/Survey with HE

Having asked my colleagues, the recommendations center around giving the auditor specifically what they ask for via printed materials or PDFs on a flash drive, rather than giving blanket access.  This keeps the focus solely on the requested information.  If you're using flags, flagged FDA studies can be identified via reporting.

------------------------------
MK Karafonda
Sr Product Manager
Cayuse

Original Message:
Sent: 05-23-2023 14:37
From: Anonymous Member
Subject: FDA Inspection/Survey with HE

This message was posted by a user wishing to remain anonymous

Has anyone gone through or experienced a FDA Inspection/Survey? How did you showcase Cayuse HE to the inspector, narrowed which studies were FDA studies, etc? Did you download everything on a flashdrive drive for them? Provided them a Cayuse account?

Hi Daniel,

Adding on to Dawn's comments just to let you know where Flags are and how to use them:
https://support.cayuse.com/hc/en-us/articles/360012759533-Using-Flags.
In reports, you can choose Flags to add them in.

Happy to chat about this anytime, just choose a convenient time here: https://calendly.com/matty-cayuse.

Thanks,

Matty

Can you explain how flags work? I would love to implement those, but have never seen them in Cayuse HE.

Having asked my colleagues, the recommendations center around giving the auditor specifically what they ask for via printed materials or PDFs on a flash drive, rather than giving blanket access.  This keeps the focus solely on the requested information.  If you're using flags, flagged FDA studies can be identified via reporting.

Has anyone gone through or experienced a FDA Inspection/Survey? How did you showcase Cayuse HE to the inspector, narrowed which studies were FDA studies, etc? Did you download everything on a flashdrive drive for them? Provided them a Cayuse account?

Hi Matty,  

Can you repost the link for flags? It seems to be broken.  Thanks!

Hi Daniel,

Adding on to Dawn's comments just to let you know where Flags are and how to use them:
https://support.cayuse.com/hc/en-us/articles/360012759533-Using-Flags.
In reports, you can choose Flags to add them in.

Happy to chat about this anytime, just choose a convenient time here: https://calendly.com/matty-cayuse.

Thanks,

Matty

Can you explain how flags work? I would love to implement those, but have never seen them in Cayuse HE.

Having asked my colleagues, the recommendations center around giving the auditor specifically what they ask for via printed materials or PDFs on a flash drive, rather than giving blanket access.  This keeps the focus solely on the requested information.  If you're using flags, flagged FDA studies can be identified via reporting.

Has anyone gone through or experienced a FDA Inspection/Survey? How did you showcase Cayuse HE to the inspector, narrowed which studies were FDA studies, etc? Did you download everything on a flashdrive drive for them? Provided them a Cayuse account?

Having asked my colleagues, the recommendations center around giving the auditor specifically what they ask for via printed materials or PDFs on a flash drive, rather than giving blanket access.  This keeps the focus solely on the requested information.  If you're using flags, flagged FDA studies can be identified via reporting.

------------------------------
MK Karafonda
Sr Product Manager
Cayuse

Original Message:
Sent: 05-23-2023 14:37
From: Anonymous Member
Subject: FDA Inspection/Survey with HE

This message was posted by a user wishing to remain anonymous

Has anyone gone through or experienced a FDA Inspection/Survey? How did you showcase Cayuse HE to the inspector, narrowed which studies were FDA studies, etc? Did you download everything on a flashdrive drive for them? Provided them a Cayuse account?