Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi all,

   Any recommendations for electronic quality management system for small size company ~ 100 employees) ?  

The role of this company is to import and distribute consumer based medical device products. The design control and manufacturing is handled by corporate office or products purchased directly from 3rd party. 

The role of this company is to handle consumer calls and supplier management, document management, and only some relabel or rework of mostly packaging or master carton and not the product itself.

Since this is a consumer based product, the complaint handling needs to also have someway to manage consumer calls via chat, emails, phone and even social media.

So far challenge has been that most of the eQMS vendors that support 21 CFR 820 or ISO 13485, do not have flexibility for handling consumer calls. For all other modules such as supplier management, audit management, incoming inspection, CAPA (not related to products) internal process can be updated to new eQMS module. 


Any suggestions for this is greatly appreciated. 

thanks you. 

Hello,

Please contact me at my email address (bashar@makromed.com) for more info on this inquiry. Our complaint handling system, InfoMed, designed for 21 CFR 820 compliance, has been used at several consumer products companies (ex: cosmetics) where the complaints volume is very high and complaints are received by phone calls and social media contacts. In addition, we have other eQMS apps for NCE, CAPA, Audits, Training, etc.

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

Original Message:
Sent: 14-Nov-2019 09:10
From: Anonymous Member
Subject: Recommendations for eQMS systems for small size company

This message was posted by a user wishing to remain anonymous

Hi all,

   Any recommendations for electronic quality management system for small size company ~ 100 employees) ?

The role of this company is to import and distribute consumer based medical device products. The design control and manufacturing is handled by corporate office or products purchased directly from 3rd party.

The role of this company is to handle consumer calls and supplier management, document management, and only some relabel or rework of mostly packaging or master carton and not the product itself.

Since this is a consumer based product, the complaint handling needs to also have someway to manage consumer calls via chat, emails, phone and even social media.

So far challenge has been that most of the eQMS vendors that support 21 CFR 820 or ISO 13485, do not have flexibility for handling consumer calls. For all other modules such as supplier management, audit management, incoming inspection, CAPA (not related to products) internal process can be updated to new eQMS module.


Any suggestions for this is greatly appreciated.

thanks you.

You might need to look at a couple different systems especially if you are looking at one to manage just consumer calls because while the eQMS systems are set up for complaints, they may not have the capability for all types of consumer calls.  There are different systems out there for call handling, customer feedback, and definitely look at a system flexible enough to include field(s) for determining adverse event reporting.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 15-Nov-2019 09:38
From: Barry Ashar
Subject: Recommendations for eQMS systems for small size company

Hello,

Please contact me at my email address (bashar@makromed.com) for more info on this inquiry. Our complaint handling system, InfoMed, designed for 21 CFR 820 compliance, has been used at several consumer products companies (ex: cosmetics) where the complaints volume is very high and complaints are received by phone calls and social media contacts. In addition, we have other eQMS apps for NCE, CAPA, Audits, Training, etc.

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

Original Message:
Sent: 14-Nov-2019 09:10
From: Anonymous Member
Subject: Recommendations for eQMS systems for small size company

This message was posted by a user wishing to remain anonymous

Hi all,

   Any recommendations for electronic quality management system for small size company ~ 100 employees) ?

The role of this company is to import and distribute consumer based medical device products. The design control and manufacturing is handled by corporate office or products purchased directly from 3rd party.

The role of this company is to handle consumer calls and supplier management, document management, and only some relabel or rework of mostly packaging or master carton and not the product itself.

Since this is a consumer based product, the complaint handling needs to also have someway to manage consumer calls via chat, emails, phone and even social media.

So far challenge has been that most of the eQMS vendors that support 21 CFR 820 or ISO 13485, do not have flexibility for handling consumer calls. For all other modules such as supplier management, audit management, incoming inspection, CAPA (not related to products) internal process can be updated to new eQMS module.


Any suggestions for this is greatly appreciated.

thanks you.