Regulatory Open Forum

Wondering if there are other RAPS members who also use Greenlight Guru software for their electronic quality management system(QMS).  I am looking to connect with other medical device manufacturers who manage multiple projects in their QMS, to discuss/share best practices and pain points in using the system, particularly in the quality event workspaces.

UPDATE: I would like to clarify that we are already a Greenlight Guru customer; therefore, not seeking alternative product suggestions.  That being said, other RAPS members may benefit from the discussions below re: experiences using the various eQMS software available.

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Sandra Veenstra
Director - Quality Assurance and Regulatory Affair
Moncton NB
Canada
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Hi Sandra, 
We just started 
Feel free to contact me.

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Adi Michaeli, RAC
Regulatory and Compliance Manager
Vancouver BC
Canada
------------------------------

Original Message:
Sent: 01-Feb-2022 14:41
From: Sandra Veenstra
Subject: Greenlight Guru eQMS

Wondering if there are other RAPS members who also use Greenlight Guru software for their electronic quality management system(QMS).  I am looking to connect with other medical device manufacturers who manage multiple projects in their QMS, to discuss/share best practices and pain points in using the system, particularly in the quality event workspaces.

------------------------------
Sandra Veenstra
Director - Quality Assurance and Regulatory Affair
Moncton NB
Canada
------------------------------

Hi Sandra,
I have used it at my work place. Its a great system. 

Happy to answer any questions. 

------------------------------
RIYA SHAH

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Original Message:
Sent: 01-Feb-2022 19:13
From: Adi Michaeli, RAC
Subject: Greenlight Guru eQMS

Hi Sandra,
We just started
Feel free to contact me.

------------------------------
Adi Michaeli, RAC
Regulatory and Compliance Manager
Vancouver BC
Canada

Original Message:
Sent: 01-Feb-2022 14:41
From: Sandra Veenstra
Subject: Greenlight Guru eQMS

Wondering if there are other RAPS members who also use Greenlight Guru software for their electronic quality management system(QMS).  I am looking to connect with other medical device manufacturers who manage multiple projects in their QMS, to discuss/share best practices and pain points in using the system, particularly in the quality event workspaces.

------------------------------
Sandra Veenstra
Director - Quality Assurance and Regulatory Affair
Moncton NB
Canada
------------------------------

Hello,

we are using Greenlight Guru only for our R&D documents, not for the QARA documents
If we would fine a better alternative for the R&D documents (especially the risk management), we would even switch to another application as it is in Greenlight Guru not easy to maintain an FDA compatible risk management file

Greetings,

------------------------------
Franky Dubois
QA/RA Manager
Gent
Belgium
------------------------------

Original Message:
Sent: 01-Feb-2022 14:41
From: Sandra Veenstra
Subject: Greenlight Guru eQMS

Wondering if there are other RAPS members who also use Greenlight Guru software for their electronic quality management system(QMS).  I am looking to connect with other medical device manufacturers who manage multiple projects in their QMS, to discuss/share best practices and pain points in using the system, particularly in the quality event workspaces.

------------------------------
Sandra Veenstra
Director - Quality Assurance and Regulatory Affair
Moncton NB
Canada
------------------------------

Frank:

Have a you looked at Microsoft Sharepoint/Teams combo as a platform or hosted app for your eQMS? There are several out-of-the box offering and then some more ways to implement with Microsoft secure, encrypted, authenticated cloud app services you can custom build with low-code MS platforms, Office 365 /Sharepoint online/Teams, etc Essentially - low-code allows CUSTOMIZATION without the coding!

There are several vendors out there who offer cloud based systems.
Let me know if there is interest.
BTW Microsofy has been 3rd party-audited for GxP regulatory compliance, e.g. 21 CFR Part 11.

With regards to using Microsoft to customize a solution -see www.estarhelper.com, i.e. our very own apps designed to turbo-charge the upcoming (soon mandatory) FDA CDRH Premarket Notification template for 510K, De Novo, PMAs.
FDA eSTAR info here at FDA site --
https://www.fda.gov/medical-devices/how-study-and-market-your-device/voluntary-estar-program





------------------------------
Ram Balani
CEO
FDASmart Inc. /eSTARHelper LLC www.estarhelper.com
Amawalk , New York
rbalani@fdasmart.com
2019130558
https://tinyurl.com/2wkxp69y
on US FDA eSTAR for 510(K)
------------------------------

Original Message:
Sent: 02-Feb-2022 07:25
From: Franky Dubois
Subject: Greenlight Guru eQMS

Hello,

we are using Greenlight Guru only for our R&D documents, not for the QARA documents
If we would fine a better alternative for the R&D documents (especially the risk management), we would even switch to another application as it is in Greenlight Guru not easy to maintain an FDA compatible risk management file

Greetings,

------------------------------
Franky Dubois
QA/RA Manager
Gent
Belgium

Original Message:
Sent: 01-Feb-2022 14:41
From: Sandra Veenstra
Subject: Greenlight Guru eQMS

Wondering if there are other RAPS members who also use Greenlight Guru software for their electronic quality management system(QMS).  I am looking to connect with other medical device manufacturers who manage multiple projects in their QMS, to discuss/share best practices and pain points in using the system, particularly in the quality event workspaces.

------------------------------
Sandra Veenstra
Director - Quality Assurance and Regulatory Affair
Moncton NB
Canada
------------------------------

Ram,

I would be interested in any of these you think is worth looking into for a small medical device company who already uses MS Teams.

Thanks,

will

------------------------------
William Coulston PMP, MS, RAC
Director of Quality & Regulatory Affairs
San Antonio TX
United States
------------------------------

Original Message:
Sent: 02-Feb-2022 08:04
From: Ram Balani
Subject: Greenlight Guru eQMS

Frank:

Have a you looked at Microsoft Sharepoint/Teams combo as a platform or hosted app for your eQMS? There are several out-of-the box offering and then some more ways to implement with Microsoft secure, encrypted, authenticated cloud app services you can custom build with low-code MS platforms, Office 365 /Sharepoint online/Teams, etc Essentially - low-code allows CUSTOMIZATION without the coding!

There are several vendors out there who offer cloud based systems.
Let me know if there is interest.
BTW Microsofy has been 3rd party-audited for GxP regulatory compliance, e.g. 21 CFR Part 11.

With regards to using Microsoft to customize a solution -see www.estarhelper.com, i.e. our very own apps designed to turbo-charge the upcoming (soon mandatory) FDA CDRH Premarket Notification template for 510K, De Novo, PMAs.
FDA eSTAR info here at FDA site --
https://www.fda.gov/medical-devices/how-study-and-market-your-device/voluntary-estar-program





------------------------------
Ram Balani
CEO
FDASmart Inc. /eSTARHelper LLC www.estarhelper.com
Amawalk , New York
rbalani@fdasmart.com
2019130558
https://tinyurl.com/2wkxp69y
on US FDA eSTAR for 510(K)

Original Message:
Sent: 02-Feb-2022 07:25
From: Franky Dubois
Subject: Greenlight Guru eQMS

Hello,

we are using Greenlight Guru only for our R&D documents, not for the QARA documents
If we would fine a better alternative for the R&D documents (especially the risk management), we would even switch to another application as it is in Greenlight Guru not easy to maintain an FDA compatible risk management file

Greetings,

------------------------------
Franky Dubois
QA/RA Manager
Gent
Belgium

Original Message:
Sent: 01-Feb-2022 14:41
From: Sandra Veenstra
Subject: Greenlight Guru eQMS

Wondering if there are other RAPS members who also use Greenlight Guru software for their electronic quality management system(QMS).  I am looking to connect with other medical device manufacturers who manage multiple projects in their QMS, to discuss/share best practices and pain points in using the system, particularly in the quality event workspaces.

------------------------------
Sandra Veenstra
Director - Quality Assurance and Regulatory Affair
Moncton NB
Canada
------------------------------

Hello,
i am in the process of getting them for design controls as well...i kept all my QA documents in another eQMS called QCBD...
i think if they are not great for Dfmea you can use Microsoft

------------------------------
Bedwuine Senatus
Springfield NJ
United States
------------------------------

Original Message:
Sent: 02-Feb-2022 07:25
From: Franky Dubois
Subject: Greenlight Guru eQMS

Hello,

we are using Greenlight Guru only for our R&D documents, not for the QARA documents
If we would fine a better alternative for the R&D documents (especially the risk management), we would even switch to another application as it is in Greenlight Guru not easy to maintain an FDA compatible risk management file

Greetings,

------------------------------
Franky Dubois
QA/RA Manager
Gent
Belgium

Original Message:
Sent: 01-Feb-2022 14:41
From: Sandra Veenstra
Subject: Greenlight Guru eQMS

Wondering if there are other RAPS members who also use Greenlight Guru software for their electronic quality management system(QMS).  I am looking to connect with other medical device manufacturers who manage multiple projects in their QMS, to discuss/share best practices and pain points in using the system, particularly in the quality event workspaces.

------------------------------
Sandra Veenstra
Director - Quality Assurance and Regulatory Affair
Moncton NB
Canada
------------------------------

Hi Sandra

We have been using Greenlight Guru for over 2 years. We use it for managing DHFs, DMRs, CAPA, Training, NC etc. Happy to share / discuss, please feel free to reach out. 


------------------------------
Murtuza Bohari, RAC
Quality and Regulatory Manager
Canterbury Scientific Limited
Christchurch, New Zealand
mbohari@canterburyscientific.com
+64 21756098
------------------------------

Original Message:
Sent: 01-Feb-2022 14:41
From: Sandra Veenstra
Subject: Greenlight Guru eQMS

Wondering if there are other RAPS members who also use Greenlight Guru software for their electronic quality management system(QMS).  I am looking to connect with other medical device manufacturers who manage multiple projects in their QMS, to discuss/share best practices and pain points in using the system, particularly in the quality event workspaces.

------------------------------
Sandra Veenstra
Director - Quality Assurance and Regulatory Affair
Moncton NB
Canada
------------------------------