Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

We are looking for a recommended computerized system for managing regulatory documents preparation and submission. System requirements: allows to author, review, approve, collaborate, and publish submissions ; user friendly with convenient and intuitive interface ; can be used both for documents preparation and record storage ; application of 21 CFR part 11compliant electronic signatures. Any recommendation will be appreciated. Thank you.

We are very pleased with the QT9 System.  Rolled out about 4 years ago and clearly see the benefits in coordination among team members and document control.

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Maureen Miller
General Counsel & RA Director
Lake St Louis MO
United States
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Original Message:
Sent: 17-Oct-2021 10:11
From: Anonymous Member
Subject: Computerized system for regulatory documents

This message was posted by a user wishing to remain anonymous

We are looking for a recommended computerized system for managing regulatory documents preparation and submission. System requirements: allows to author, review, approve, collaborate, and publish submissions ; user friendly with convenient and intuitive interface ; can be used both for documents preparation and record storage ; application of 21 CFR part 11compliant electronic signatures. Any recommendation will be appreciated. Thank you.

Hello,

I highly recommend this new platform Giotto Compliance, a new emerging regulatory online solution, with lots of potential that is  both user friendly and has a very clear workflow .  You can check the   website out to get aquatinted with what the solution offers. One of its main advantages in my view is that it is an AI-based solution for faster and more accurate CER (as well as other types of) literature reviews (by moving from a manual to a semi-automated, centralized, and full-digitalized CER workflow)

Giotto Compliance website: https://compliance.giotto.ai/Giotto Compliance Demo Video: https://www.youtube.com/watch?v=B-V-zbbAgIE

I hope you find this info helpful !

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Azza Gramoun
medical writer
Bonn
Germany
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Original Message:
Sent: 17-Oct-2021 10:11
From: Anonymous Member
Subject: Computerized system for regulatory documents

This message was posted by a user wishing to remain anonymous

We are looking for a recommended computerized system for managing regulatory documents preparation and submission. System requirements: allows to author, review, approve, collaborate, and publish submissions ; user friendly with convenient and intuitive interface ; can be used both for documents preparation and record storage ; application of 21 CFR part 11compliant electronic signatures. Any recommendation will be appreciated. Thank you.

Hello, I have used Essenvia (www.essenvia.com) to create and manage US and EU submission and documents.  It is an extremely efficient way to build submissions minimizing the redundancy of information and sharing information and documents across submissions.

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Michelle Lott RAC
Principal & Founder
michelle@leanraqa.com
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Original Message:
Sent: 17-Oct-2021 10:11
From: Anonymous Member
Subject: Computerized system for regulatory documents

This message was posted by a user wishing to remain anonymous

We are looking for a recommended computerized system for managing regulatory documents preparation and submission. System requirements: allows to author, review, approve, collaborate, and publish submissions ; user friendly with convenient and intuitive interface ; can be used both for documents preparation and record storage ; application of 21 CFR part 11compliant electronic signatures. Any recommendation will be appreciated. Thank you.