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Dean Murphy RAC
Director, Regulatory Affairs
Vistakon, Johnson & Johnson Vision Care, Inc.
Jacksonville FL
United States
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So there are several ways to manage this. Typical Quality Systems sofware (wholistic in their approach - called Enterprise Quality Management Systems), like EtQ, Siemens, provide software that can be customized for this purpose. There are also out-of-the box solutions, such as Aris Global's Register
® and TrackWise (another total quality systems software) that are specific for the purpose of registration tracking. I have provided the links to the solutions below. Please note that there are other Enterprise Quality Systems that can also provide such customized requirements. There are advantages to having someone else maintain the total aspects of compliance, validation, needs, best practices and such that are associated with an out-of-the box solution. This is due to the expertise associated with the software or the process. Out-of-the box solutions can contain the industry's best practices, can be updated due to recent regulatory guidances or changes in the regulations by the vendor and then pushed at a lower cost to the consumer, as it is distributed amongst many customers. Typically, customized solutions are an extra burdon on the internal personnel (IT and professionals), as the regulatory customizations may not be a specialty of the vendor. Thus, the internal resources must maintain and update the general system to meet their needs and again, it becomes more customized and costs are continuously applied as such (not distributed amongst many customers, but specific to the client's needs).
Here is the link for Aris Global's system: (specific to registrations for the pharmaceutical, medical device and biologics industry and encompasses as many, or as limited aspects about registration tracking, registration authority communications and many other pertenent regulatory requirements associated with global registrations)
http://www.arisglobal.com/Regulatory_Affairs/Register.php Here is the link for TrackWise's system: (this is an enterprise quality management system that has a component that tracks registrations:
http://www.spartasystems.com/industries/pharmaceutical-biotech/regulatory-affairs/ Here is the EtQ site: (this is an enterprise quality management system)
http://www.etq.com/reliance/ Here is the Siemens PLM (Product Life Cycle Management system) site:
http://www.plm.automation.siemens.com/en_us/about_us/index.shtml (NOTE: this product was not made for the FDA industries, but can be customized, as it works for any regulated industry)
For a very inexpensive program, Microsoft Access is a database that can be configured to provide the same aspects customized to your needs. You just need someone to know how to program it (set it up), validate it and maintain it.
I hope this helps in your quest, or at least to get started.
Dean Murphy
Original Message:
Sent: 08-29-2012 00:33
From: Julie Omohundro
Subject: Product Registration Database
I am also interested in registration-tracking software. I would prefer something that is just a step up from an Excel database, without a lot of extra bells and whistles, especially at a nice price.
For those of you who are pushing the limits of Excel on this right now, what are some of the capabilities you would most like in dedicated registration software that Excel either doesn't do or doesn't do very well, especially for lots of products registered in lots of different jurisdictions worldwide?
Julie Omohundro RAC
RAQA Services
Research Triangle Park NC
United States
Original Message:
Sent: 08-27-2012 02:27
From: Martin Gabler
Subject: Product Registration Database
In order to get a better overview over the worldwide registrations of a company's products I am looking for software that can be used for this purpose. Does anyone know of such tools? Are you simply using Excel lists or a database?
Any suggestions are appreciated.
Thank you!
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Martin Gabler
Regulatory Affairs Specialist
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