Hi Tina
Simply put, you have to either type in the information or attach documents in to the
Smart Builder in RAMS. Once complete, it creates a dossier in a structured way for a specific country. It also has embedded country specific information which you can see in the quick view or in the final draft / published version. You will still need to maintain DHF / RMF documentation etc. outside which you attach in to your dossier in RAMS.
We've used the manual way of maintaining dossiers in the past however we find RAMS much easier to maintain our massively lengthy dossiers. I don't think there is an API.
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Murtuza Bohari
Quality and Regulatory Manager
Canterbury Scientific Limited
Christchurch, New Zealand
mbohari@canterburyscientific.com+64 21756098
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Original Message:
Sent: 25-Aug-2021 19:35
From: Tina O'Brien
Subject: Submission Creation Tools
Thanks for the info, Murtuza! I have a RAMS account, but haven't been using the tools. Does the tool simply format documents into the proper folder structure for the target country or does it help create the required documentation e.g. application forms, summaries, etc.? Do you have to manually maintain the source documentation from your DHF/RMF/etc. or is there an API to connect to your doc control system?
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Tina O'Brien RAC, MS
Director of Regulatory Affairs
Airport Oaks
New Zealand
Original Message:
Sent: 25-Aug-2021 01:33
From: Murtuza Bohari
Subject: Submission Creation Tools
Hi Tina
That is a great question.
We are currently using RAMS (Regulatory Affairs Management Suite) to help create technical documentation file for IVDR submissions. RAMS is provided by Emergo and it has been enormously helpful.
Worth having a look if you're wanting to go electronic. It is ISO 13485:2016 and 21 CFR Part 11 compliant.
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Murtuza Bohari
Quality and Regulatory Manager
Canterbury Scientific Limited
Christchurch, New Zealand
mbohari@canterburyscientific.com
+64 21756098
Original Message:
Sent: 25-Aug-2021 01:07
From: Tina O'Brien
Subject: Submission Creation Tools
With the potential for CTD-style submission formats on the medical device horizon, I've been looking into tools to help manage my submission dossiers to I can easily "grab" content to create country-specific application packages. However, there's not much out there that's both bespoke for devices AND affordable.
I've recently implemented the IMDRF ToC folder structure on OneDrive, which has been massively helpful but still not as automated or efficient as I'd like.
What tools do you use to pull together the plethora of content required for submissions?
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Tina O'Brien RAC, MS
Director of Regulatory Affairs
Airport Oaks
New Zealand
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