Regulatory Open Forum

Hi Everyone,

I currently work for a small team in a Class 2 Medical Device company and we are currently in the mist of transitioning to a new division. We currently have SAP By Design implemented, but it currently does not allow for complaint tracking, MDR submissions, document controls, etc., or any other "quality compliance" features. Our SAP is currently set up for Sales and Service Administration mainly.
I am curious as to what software is out there that is relatively not too expensive for a small division and software is easy to navigate. I had used Master Control and Trackwise in past companies, and they were  pretty robust programs. Unfortunately, we do not have the man power currently to have this program where we can have a full time administrator to manage this system in our dept.  Any help is much appreciated.

Thanks,
Vicki

------------------------------
Vicki Ong
Sr. Regulatory Affairs/Quality System Specialist
Irvine CA
United States
------------------------------

Vicki,

I would recommend Grand Avenue Software.  Their software is modular so you can add the elements of the quality system you need (e.g., doc control/training, complaints, design control, etc.).

------------------------------
Judson Guericke
Eden Prairie MN
United States
------------------------------

Original Message:
Sent: 19-May-2020 16:16
From: Vicki Ong
Subject: Need Recommendations for QMS Software Program

Hi Everyone,

I currently work for a small team in a Class 2 Medical Device company and we are currently in the mist of transitioning to a new division. We currently have SAP By Design implemented, but it currently does not allow for complaint tracking, MDR submissions, document controls, etc., or any other "quality compliance" features. Our SAP is currently set up for Sales and Service Administration mainly.
I am curious as to what software is out there that is relatively not too expensive for a small division and software is easy to navigate. I had used Master Control and Trackwise in past companies, and they were  pretty robust programs. Unfortunately, we do not have the man power currently to have this program where we can have a full time administrator to manage this system in our dept.  Any help is much appreciated.

Thanks,
Vicki

------------------------------
Vicki Ong
Sr. Regulatory Affairs/Quality System Specialist
Irvine CA
United States
------------------------------

Thank you for the recommendation Judson. I will look into it.

------------------------------
Vicki Ong
Sr. Regulatory Affairs/Quality System Specialist
Irvine CA
United States
------------------------------

Original Message:
Sent: 20-May-2020 08:21
From: Judson Guericke
Subject: Need Recommendations for QMS Software Program

Vicki,

I would recommend Grand Avenue Software.  Their software is modular so you can add the elements of the quality system you need (e.g., doc control/training, complaints, design control, etc.).

------------------------------
Judson Guericke
Eden Prairie MN
United States

Original Message:
Sent: 19-May-2020 16:16
From: Vicki Ong
Subject: Need Recommendations for QMS Software Program

Hi Everyone,

I currently work for a small team in a Class 2 Medical Device company and we are currently in the mist of transitioning to a new division. We currently have SAP By Design implemented, but it currently does not allow for complaint tracking, MDR submissions, document controls, etc., or any other "quality compliance" features. Our SAP is currently set up for Sales and Service Administration mainly.
I am curious as to what software is out there that is relatively not too expensive for a small division and software is easy to navigate. I had used Master Control and Trackwise in past companies, and they were  pretty robust programs. Unfortunately, we do not have the man power currently to have this program where we can have a full time administrator to manage this system in our dept.  Any help is much appreciated.

Thanks,
Vicki

------------------------------
Vicki Ong
Sr. Regulatory Affairs/Quality System Specialist
Irvine CA
United States
------------------------------

I actually second the Grand Avenue Software suggestion. Very easy to implement and intuitive. I'm using it at the 4th different company.

------------------------------
Jackie Torfin
Vice President, Global QA and Regulatory Compliance
Maple Grove MN
United States
------------------------------

Original Message:
Sent: 19-May-2020 16:16
From: Vicki Ong
Subject: Need Recommendations for QMS Software Program

Hi Everyone,

I currently work for a small team in a Class 2 Medical Device company and we are currently in the mist of transitioning to a new division. We currently have SAP By Design implemented, but it currently does not allow for complaint tracking, MDR submissions, document controls, etc., or any other "quality compliance" features. Our SAP is currently set up for Sales and Service Administration mainly.
I am curious as to what software is out there that is relatively not too expensive for a small division and software is easy to navigate. I had used Master Control and Trackwise in past companies, and they were  pretty robust programs. Unfortunately, we do not have the man power currently to have this program where we can have a full time administrator to manage this system in our dept.  Any help is much appreciated.

Thanks,
Vicki

------------------------------
Vicki Ong
Sr. Regulatory Affairs/Quality System Specialist
Irvine CA
United States
------------------------------

Thank you Jackie, I will look into it.

------------------------------
Vicki Ong
Sr. Regulatory Affairs/Quality System Specialist
Irvine CA
United States
------------------------------

Original Message:
Sent: 20-May-2020 08:36
From: Jackie Torfin
Subject: Need Recommendations for QMS Software Program

I actually second the Grand Avenue Software suggestion. Very easy to implement and intuitive. I'm using it at the 4th different company.

------------------------------
Jackie Torfin
Vice President, Global QA and Regulatory Compliance
Maple Grove MN
United States

Original Message:
Sent: 19-May-2020 16:16
From: Vicki Ong
Subject: Need Recommendations for QMS Software Program

Hi Everyone,

I currently work for a small team in a Class 2 Medical Device company and we are currently in the mist of transitioning to a new division. We currently have SAP By Design implemented, but it currently does not allow for complaint tracking, MDR submissions, document controls, etc., or any other "quality compliance" features. Our SAP is currently set up for Sales and Service Administration mainly.
I am curious as to what software is out there that is relatively not too expensive for a small division and software is easy to navigate. I had used Master Control and Trackwise in past companies, and they were  pretty robust programs. Unfortunately, we do not have the man power currently to have this program where we can have a full time administrator to manage this system in our dept.  Any help is much appreciated.

Thanks,
Vicki

------------------------------
Vicki Ong
Sr. Regulatory Affairs/Quality System Specialist
Irvine CA
United States
------------------------------

Vicki,

If internal IT support is the gating issue, then consider SaaS (Software as a Service).

There are numerous MIS, QMS, PDLM, etc. systems that are available from the cloud, with little internal support required.

------------------------------
Michael Chellson
RAC
------------------------------

Original Message:
Sent: 19-May-2020 16:16
From: Vicki Ong
Subject: Need Recommendations for QMS Software Program

Hi Everyone,

I currently work for a small team in a Class 2 Medical Device company and we are currently in the mist of transitioning to a new division. We currently have SAP By Design implemented, but it currently does not allow for complaint tracking, MDR submissions, document controls, etc., or any other "quality compliance" features. Our SAP is currently set up for Sales and Service Administration mainly.
I am curious as to what software is out there that is relatively not too expensive for a small division and software is easy to navigate. I had used Master Control and Trackwise in past companies, and they were  pretty robust programs. Unfortunately, we do not have the man power currently to have this program where we can have a full time administrator to manage this system in our dept.  Any help is much appreciated.

Thanks,
Vicki

------------------------------
Vicki Ong
Sr. Regulatory Affairs/Quality System Specialist
Irvine CA
United States
------------------------------

Hello Vicki
Greenlight Guru is another option. I sat through one of their training programs and found the software to be quite easy and simple, especially for document control, risk management, and design control. I am not sure about complaints tracking but you could contact them and get the details. I will be happy to facilitate an introduction if needed.
Best regards
Naveen Agarwal

------------------------------
Naveen Agarwal
Jacksonville FL
United States
------------------------------

Original Message:
Sent: 19-May-2020 16:16
From: Vicki Ong
Subject: Need Recommendations for QMS Software Program

Hi Everyone,

I currently work for a small team in a Class 2 Medical Device company and we are currently in the mist of transitioning to a new division. We currently have SAP By Design implemented, but it currently does not allow for complaint tracking, MDR submissions, document controls, etc., or any other "quality compliance" features. Our SAP is currently set up for Sales and Service Administration mainly.
I am curious as to what software is out there that is relatively not too expensive for a small division and software is easy to navigate. I had used Master Control and Trackwise in past companies, and they were  pretty robust programs. Unfortunately, we do not have the man power currently to have this program where we can have a full time administrator to manage this system in our dept.  Any help is much appreciated.

Thanks,
Vicki

------------------------------
Vicki Ong
Sr. Regulatory Affairs/Quality System Specialist
Irvine CA
United States
------------------------------

Thank you for the recommendations Naveen, I will look into it! I have a few others that people are recommending too!

------------------------------
Vicki Ong
Sr. Regulatory Affairs/Quality System Specialist
Irvine CA
United States
------------------------------

Original Message:
Sent: 20-May-2020 09:00
From: Naveen Agarwal
Subject: Need Recommendations for QMS Software Program

Hello Vicki
Greenlight Guru is another option. I sat through one of their training programs and found the software to be quite easy and simple, especially for document control, risk management, and design control. I am not sure about complaints tracking but you could contact them and get the details. I will be happy to facilitate an introduction if needed.
Best regards
Naveen Agarwal

------------------------------
Naveen Agarwal
Jacksonville FL
United States

Original Message:
Sent: 19-May-2020 16:16
From: Vicki Ong
Subject: Need Recommendations for QMS Software Program

Hi Everyone,

I currently work for a small team in a Class 2 Medical Device company and we are currently in the mist of transitioning to a new division. We currently have SAP By Design implemented, but it currently does not allow for complaint tracking, MDR submissions, document controls, etc., or any other "quality compliance" features. Our SAP is currently set up for Sales and Service Administration mainly.
I am curious as to what software is out there that is relatively not too expensive for a small division and software is easy to navigate. I had used Master Control and Trackwise in past companies, and they were  pretty robust programs. Unfortunately, we do not have the man power currently to have this program where we can have a full time administrator to manage this system in our dept.  Any help is much appreciated.

Thanks,
Vicki

------------------------------
Vicki Ong
Sr. Regulatory Affairs/Quality System Specialist
Irvine CA
United States
------------------------------

Grand Avenue is a good option, as others have mentioned.  I would also suggest IMSXpress, since you mentioned something that is inexpensive and it will cover everything you mentioned.  I have implemented this with multiple clients - it works well and won't break the bank.

------------------------------
James Webb
Vice President and Director, Quality Assurance
Minneapolis MN
United States
------------------------------

Original Message:
Sent: 19-May-2020 16:16
From: Vicki Ong
Subject: Need Recommendations for QMS Software Program

Hi Everyone,

I currently work for a small team in a Class 2 Medical Device company and we are currently in the mist of transitioning to a new division. We currently have SAP By Design implemented, but it currently does not allow for complaint tracking, MDR submissions, document controls, etc., or any other "quality compliance" features. Our SAP is currently set up for Sales and Service Administration mainly.
I am curious as to what software is out there that is relatively not too expensive for a small division and software is easy to navigate. I had used Master Control and Trackwise in past companies, and they were  pretty robust programs. Unfortunately, we do not have the man power currently to have this program where we can have a full time administrator to manage this system in our dept.  Any help is much appreciated.

Thanks,
Vicki

------------------------------
Vicki Ong
Sr. Regulatory Affairs/Quality System Specialist
Irvine CA
United States
------------------------------

Thank you James, I will look into it!

------------------------------
Vicki Ong
Sr. Regulatory Affairs/Quality System Specialist
Irvine CA
United States
------------------------------

Original Message:
Sent: 20-May-2020 09:28
From: James Webb
Subject: Need Recommendations for QMS Software Program

Grand Avenue is a good option, as others have mentioned.  I would also suggest IMSXpress, since you mentioned something that is inexpensive and it will cover everything you mentioned.  I have implemented this with multiple clients - it works well and won't break the bank.

------------------------------
James Webb
Vice President and Director, Quality Assurance
Minneapolis MN
United States

Original Message:
Sent: 19-May-2020 16:16
From: Vicki Ong
Subject: Need Recommendations for QMS Software Program

Hi Everyone,

I currently work for a small team in a Class 2 Medical Device company and we are currently in the mist of transitioning to a new division. We currently have SAP By Design implemented, but it currently does not allow for complaint tracking, MDR submissions, document controls, etc., or any other "quality compliance" features. Our SAP is currently set up for Sales and Service Administration mainly.
I am curious as to what software is out there that is relatively not too expensive for a small division and software is easy to navigate. I had used Master Control and Trackwise in past companies, and they were  pretty robust programs. Unfortunately, we do not have the man power currently to have this program where we can have a full time administrator to manage this system in our dept.  Any help is much appreciated.

Thanks,
Vicki

------------------------------
Vicki Ong
Sr. Regulatory Affairs/Quality System Specialist
Irvine CA
United States
------------------------------

I have been working with  IMSXpress for a while, and recently am looking at Grand Avenue. But I have to say I just saw Qualityze yesterday and they are relatively  inexpensive  (<10k for 20 users) and have great dashboard reporting features for management  use.  And looks like (since it is Sales Force product) that it integrates smoothly with Sales Force CRM with importing Cases for feedback/complaint management.

Going to try it out -free one week trial.   

Much less  expensive  for a start-up than the large or medium software packages.


------------------------------
Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com
------------------------------

Original Message:
Sent: 20-May-2020 09:28
From: James Webb
Subject: Need Recommendations for QMS Software Program

Grand Avenue is a good option, as others have mentioned.  I would also suggest IMSXpress, since you mentioned something that is inexpensive and it will cover everything you mentioned.  I have implemented this with multiple clients - it works well and won't break the bank.

------------------------------
James Webb
Vice President and Director, Quality Assurance
Minneapolis MN
United States

Original Message:
Sent: 19-May-2020 16:16
From: Vicki Ong
Subject: Need Recommendations for QMS Software Program

Hi Everyone,

I currently work for a small team in a Class 2 Medical Device company and we are currently in the mist of transitioning to a new division. We currently have SAP By Design implemented, but it currently does not allow for complaint tracking, MDR submissions, document controls, etc., or any other "quality compliance" features. Our SAP is currently set up for Sales and Service Administration mainly.
I am curious as to what software is out there that is relatively not too expensive for a small division and software is easy to navigate. I had used Master Control and Trackwise in past companies, and they were  pretty robust programs. Unfortunately, we do not have the man power currently to have this program where we can have a full time administrator to manage this system in our dept.  Any help is much appreciated.

Thanks,
Vicki

------------------------------
Vicki Ong
Sr. Regulatory Affairs/Quality System Specialist
Irvine CA
United States
------------------------------

Vicki, one additional consideration - look for a software that will allow you to grow or easily transition, the last thing you want is something that works today, but is limiting in capacity or functionality and requires you to completely redesign your processes down the road. Make sure you ask the right questions of your potential vendors. I haven't worked with a lot of the smaller vendors, but frequently find during audits that software limitations become huge compliance issues.

------------------------------
David W. Husman, Ph.D., RAC
Senior Consultant
PAREXEL Consulting
Greenville, SC
USA
------------------------------

Original Message:
Sent: 19-May-2020 16:16
From: Vicki Ong
Subject: Need Recommendations for QMS Software Program

Hi Everyone,

I currently work for a small team in a Class 2 Medical Device company and we are currently in the mist of transitioning to a new division. We currently have SAP By Design implemented, but it currently does not allow for complaint tracking, MDR submissions, document controls, etc., or any other "quality compliance" features. Our SAP is currently set up for Sales and Service Administration mainly.
I am curious as to what software is out there that is relatively not too expensive for a small division and software is easy to navigate. I had used Master Control and Trackwise in past companies, and they were  pretty robust programs. Unfortunately, we do not have the man power currently to have this program where we can have a full time administrator to manage this system in our dept.  Any help is much appreciated.

Thanks,
Vicki

------------------------------
Vicki Ong
Sr. Regulatory Affairs/Quality System Specialist
Irvine CA
United States
------------------------------

I completely agree with Dave, however at 2 of the companies I used Grand Avenue, we deployed it globally at up to 9 different locations with 2000 users. We had no process issues or growing pains with the SW as we grew. That being said, it is an English only software.

------------------------------
Jackie Torfin
Vice President, Global QA and Regulatory Compliance
Maple Grove MN
United States
------------------------------

Original Message:
Sent: 20-May-2020 09:31
From: David Husman
Subject: Need Recommendations for QMS Software Program

Vicki, one additional consideration - look for a software that will allow you to grow or easily transition, the last thing you want is something that works today, but is limiting in capacity or functionality and requires you to completely redesign your processes down the road. Make sure you ask the right questions of your potential vendors. I haven't worked with a lot of the smaller vendors, but frequently find during audits that software limitations become huge compliance issues.

------------------------------
David W. Husman, Ph.D., RAC
Senior Consultant
PAREXEL Consulting
Greenville, SC
USA

Original Message:
Sent: 19-May-2020 16:16
From: Vicki Ong
Subject: Need Recommendations for QMS Software Program

Hi Everyone,

I currently work for a small team in a Class 2 Medical Device company and we are currently in the mist of transitioning to a new division. We currently have SAP By Design implemented, but it currently does not allow for complaint tracking, MDR submissions, document controls, etc., or any other "quality compliance" features. Our SAP is currently set up for Sales and Service Administration mainly.
I am curious as to what software is out there that is relatively not too expensive for a small division and software is easy to navigate. I had used Master Control and Trackwise in past companies, and they were  pretty robust programs. Unfortunately, we do not have the man power currently to have this program where we can have a full time administrator to manage this system in our dept.  Any help is much appreciated.

Thanks,
Vicki

------------------------------
Vicki Ong
Sr. Regulatory Affairs/Quality System Specialist
Irvine CA
United States
------------------------------

This message was posted by a user wishing to remain anonymous

We are exploring Greenlight Guru right now. I love their medical device educational material, but right now, don't have any experience with their product right now.
Original Message:
Sent: 20-May-2020 09:53
From: Jackie Torfin
Subject: Need Recommendations for QMS Software Program

I completely agree with Dave, however at 2 of the companies I used Grand Avenue, we deployed it globally at up to 9 different locations with 2000 users. We had no process issues or growing pains with the SW as we grew. That being said, it is an English only software.

------------------------------
Jackie Torfin
Vice President, Global QA and Regulatory Compliance
Maple Grove MN
United States

Original Message:
Sent: 20-May-2020 09:31
From: David Husman
Subject: Need Recommendations for QMS Software Program

Vicki, one additional consideration - look for a software that will allow you to grow or easily transition, the last thing you want is something that works today, but is limiting in capacity or functionality and requires you to completely redesign your processes down the road. Make sure you ask the right questions of your potential vendors. I haven't worked with a lot of the smaller vendors, but frequently find during audits that software limitations become huge compliance issues.

------------------------------
David W. Husman, Ph.D., RAC
Senior Consultant
PAREXEL Consulting
Greenville, SC
USA

Original Message:
Sent: 19-May-2020 16:16
From: Vicki Ong
Subject: Need Recommendations for QMS Software Program

Hi Everyone,

I currently work for a small team in a Class 2 Medical Device company and we are currently in the mist of transitioning to a new division. We currently have SAP By Design implemented, but it currently does not allow for complaint tracking, MDR submissions, document controls, etc., or any other "quality compliance" features. Our SAP is currently set up for Sales and Service Administration mainly.
I am curious as to what software is out there that is relatively not too expensive for a small division and software is easy to navigate. I had used Master Control and Trackwise in past companies, and they were  pretty robust programs. Unfortunately, we do not have the man power currently to have this program where we can have a full time administrator to manage this system in our dept.  Any help is much appreciated.

Thanks,
Vicki

------------------------------
Vicki Ong
Sr. Regulatory Affairs/Quality System Specialist
Irvine CA
United States
------------------------------

Thank you David for the informative info to keep in mind. I will look into it with management and see what they want to do. Much appreciated.

------------------------------
Vicki Ong
Sr. Regulatory Affairs/Quality System Specialist
Irvine CA
United States
------------------------------

Original Message:
Sent: 20-May-2020 09:31
From: David Husman
Subject: Need Recommendations for QMS Software Program

Vicki, one additional consideration - look for a software that will allow you to grow or easily transition, the last thing you want is something that works today, but is limiting in capacity or functionality and requires you to completely redesign your processes down the road. Make sure you ask the right questions of your potential vendors. I haven't worked with a lot of the smaller vendors, but frequently find during audits that software limitations become huge compliance issues.

------------------------------
David W. Husman, Ph.D., RAC
Senior Consultant
PAREXEL Consulting
Greenville, SC
USA

Original Message:
Sent: 19-May-2020 16:16
From: Vicki Ong
Subject: Need Recommendations for QMS Software Program

Hi Everyone,

I currently work for a small team in a Class 2 Medical Device company and we are currently in the mist of transitioning to a new division. We currently have SAP By Design implemented, but it currently does not allow for complaint tracking, MDR submissions, document controls, etc., or any other "quality compliance" features. Our SAP is currently set up for Sales and Service Administration mainly.
I am curious as to what software is out there that is relatively not too expensive for a small division and software is easy to navigate. I had used Master Control and Trackwise in past companies, and they were  pretty robust programs. Unfortunately, we do not have the man power currently to have this program where we can have a full time administrator to manage this system in our dept.  Any help is much appreciated.

Thanks,
Vicki

------------------------------
Vicki Ong
Sr. Regulatory Affairs/Quality System Specialist
Irvine CA
United States
------------------------------

Hi Vicki,

One more suggestion. All of the following InfoSuite modules from Makromed are available individually or integrated, in both SaaS or locally installed system:
InfoMed - Complaint Handling and Adverse Events Reporting (FDA, EU, Canada, Australia, Japan, Brazil, Hong Kong, Singapore)
InfoCAPA - Non-conformances and CAPA (with six sigma problem solving tools embedded)
InfoAudit - Internal and supplier audits (audit checklists for multiple regs and standards built-in)
InfoPV - Process validation and Test Method validation
InfoSQA - Software development and validation

Thanks,
Barry

------------------------------
Barry Ashar
Makromed, Inc.
Salem NH
United States
------------------------------

Original Message:
Sent: 19-May-2020 16:16
From: Vicki Ong
Subject: Need Recommendations for QMS Software Program

Hi Everyone,

I currently work for a small team in a Class 2 Medical Device company and we are currently in the mist of transitioning to a new division. We currently have SAP By Design implemented, but it currently does not allow for complaint tracking, MDR submissions, document controls, etc., or any other "quality compliance" features. Our SAP is currently set up for Sales and Service Administration mainly.
I am curious as to what software is out there that is relatively not too expensive for a small division and software is easy to navigate. I had used Master Control and Trackwise in past companies, and they were  pretty robust programs. Unfortunately, we do not have the man power currently to have this program where we can have a full time administrator to manage this system in our dept.  Any help is much appreciated.

Thanks,
Vicki

------------------------------
Vicki Ong
Sr. Regulatory Affairs/Quality System Specialist
Irvine CA
United States
------------------------------

Thanks Barry for the info. Are you the main contact person for Makromed?  I will discuss with management once we are completely transition to the new division at my company (July 2020). 

Do you have a contact info that I can contact a rep if we would like set up a demo?

Let me know. 

Thanks,
Vicki

------------------------------
Vicki Ong
Sr. Regulatory Affairs/Quality System Specialist
Irvine CA
United States
------------------------------

Original Message:
Sent: 21-May-2020 10:37
From: Barry Ashar
Subject: Need Recommendations for QMS Software Program

Hi Vicki,

One more suggestion. All of the following InfoSuite modules from Makromed are available individually or integrated, in both SaaS or locally installed system:
InfoMed - Complaint Handling and Adverse Events Reporting (FDA, EU, Canada, Australia, Japan, Brazil, Hong Kong, Singapore)
InfoCAPA - Non-conformances and CAPA (with six sigma problem solving tools embedded)
InfoAudit - Internal and supplier audits (audit checklists for multiple regs and standards built-in)
InfoPV - Process validation and Test Method validation
InfoSQA - Software development and validation

Thanks,
Barry

------------------------------
Barry Ashar
Makromed, Inc.
Salem NH
United States

Original Message:
Sent: 19-May-2020 16:16
From: Vicki Ong
Subject: Need Recommendations for QMS Software Program

Hi Everyone,

I currently work for a small team in a Class 2 Medical Device company and we are currently in the mist of transitioning to a new division. We currently have SAP By Design implemented, but it currently does not allow for complaint tracking, MDR submissions, document controls, etc., or any other "quality compliance" features. Our SAP is currently set up for Sales and Service Administration mainly.
I am curious as to what software is out there that is relatively not too expensive for a small division and software is easy to navigate. I had used Master Control and Trackwise in past companies, and they were  pretty robust programs. Unfortunately, we do not have the man power currently to have this program where we can have a full time administrator to manage this system in our dept.  Any help is much appreciated.

Thanks,
Vicki

------------------------------
Vicki Ong
Sr. Regulatory Affairs/Quality System Specialist
Irvine CA
United States
------------------------------

Original Message:
Sent: 5/21/2020 3:49:00 PM
From: Vicki Ong
Subject: RE: Need Recommendations for QMS Software Program

Thanks Barry for the info. Are you the main contact person for Makromed?  I will discuss with management once we are completely transition to the new division at my company (July 2020). 

Do you have a contact info that I can contact a rep if we would like set up a demo?

Let me know. 

Thanks,
Vicki

------------------------------
Vicki Ong
Sr. Regulatory Affairs/Quality System Specialist
Irvine CA
United States
------------------------------

Original Message:
Sent: 21-May-2020 10:37
From: Barry Ashar
Subject: Need Recommendations for QMS Software Program

Hi Vicki,

One more suggestion. All of the following InfoSuite modules from Makromed are available individually or integrated, in both SaaS or locally installed system:
InfoMed - Complaint Handling and Adverse Events Reporting (FDA, EU, Canada, Australia, Japan, Brazil, Hong Kong, Singapore)
InfoCAPA - Non-conformances and CAPA (with six sigma problem solving tools embedded)
InfoAudit - Internal and supplier audits (audit checklists for multiple regs and standards built-in)
InfoPV - Process validation and Test Method validation
InfoSQA - Software development and validation

Thanks,
Barry

------------------------------
Barry Ashar
Makromed, Inc.
Salem NH
United States

Original Message:
Sent: 19-May-2020 16:16
From: Vicki Ong
Subject: Need Recommendations for QMS Software Program

Hi Everyone,

I currently work for a small team in a Class 2 Medical Device company and we are currently in the mist of transitioning to a new division. We currently have SAP By Design implemented, but it currently does not allow for complaint tracking, MDR submissions, document controls, etc., or any other "quality compliance" features. Our SAP is currently set up for Sales and Service Administration mainly.
I am curious as to what software is out there that is relatively not too expensive for a small division and software is easy to navigate. I had used Master Control and Trackwise in past companies, and they were  pretty robust programs. Unfortunately, we do not have the man power currently to have this program where we can have a full time administrator to manage this system in our dept.  Any help is much appreciated.

Thanks,
Vicki

------------------------------
Vicki Ong
Sr. Regulatory Affairs/Quality System Specialist
Irvine CA
United States
------------------------------

Hi Vicki,

I know some of the folks at Enzyme. I recommend their solution because they were in the trenches with me developing and remediating medical devices and combination products for multiple firms for many years. They know their stuff, consequently you will not only find their QMS a good fit, but their support comes with best practices.

Hope it helps.

Adam

------------------------------
Adam Atherton
Farragut TN
United States
------------------------------

Original Message:
Sent: 19-May-2020 16:16
From: Vicki Ong
Subject: Need Recommendations for QMS Software Program

Hi Everyone,

I currently work for a small team in a Class 2 Medical Device company and we are currently in the mist of transitioning to a new division. We currently have SAP By Design implemented, but it currently does not allow for complaint tracking, MDR submissions, document controls, etc., or any other "quality compliance" features. Our SAP is currently set up for Sales and Service Administration mainly.
I am curious as to what software is out there that is relatively not too expensive for a small division and software is easy to navigate. I had used Master Control and Trackwise in past companies, and they were  pretty robust programs. Unfortunately, we do not have the man power currently to have this program where we can have a full time administrator to manage this system in our dept.  Any help is much appreciated.

Thanks,
Vicki

------------------------------
Vicki Ong
Sr. Regulatory Affairs/Quality System Specialist
Irvine CA
United States
------------------------------