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Drug Safety System Solutions: A Second Opinion

by Mark Ciresi

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Scenario: Companies A and B own the same drug safety software and have spent millions over the years to purchase, license and upgrade. While nobody likes work, company A’s employees are very productive and think the software helps them do a better job. Meanwhile, company B’s employees think the software is a pain to use, makes their job miserable and they cannot be as productive as they like because they spend half of their time fantasizing about shooting the computer screen. Now be honest, do you work for company A or company B?

When you initially chose that drug safety system, several requirements guided your decision to improve upon your previous system with high hopes that the new software would keep you within regulatory compliance. 

If you are like company one, then congratulations. You have done better than most of the industry. If you are like company number two, then ask yourself: is the problem the software, lack of knowledge or shrinking budgets? If your IT staff or host company is withholding advice or assuring you that other options are expensive or impossible, then maybe you need another opinion.

Promising that we can make the system ‘fun to use’ is like student council candidates promising all day recess and free cokes. USDM cannot make working ‘fun’ but we may be able to leverage our expertise and show you how to identify ways to improve your product safety system, regardless of who is making the changes to your system. Whether you need your software customized or a more effective workflow design, we can explain the options, impacts and steps to get your system working up to its full potential.


About the Author

Mark Ciresi has 28 years of experience improving business productivity through the application of computer system solutions. Extensive knowledge of all aspects of computer systems and project life cycles in the field of health sciences. Experience is balanced between business analysis, leadership, validation and development roles. Since 2003, he has specialized in the customization of Argus Safety systems (Versions 3.3 -7.06) for pharmaceutical, biotechnology and CRO companies.


About USDM Life Sciences

USDM Life Sciences is a global life science and healthcare services company, providing strategy and compliant technology solutions to regulated industries. If you work in Life Sciences or Healthcare, partnering with USDM Life Sciences makes it easy to accelerate innovation and maximize productivity. USDM Life Sciences only focuses on regulated industries and has built trusted partnerships with the most innovative technology companies in the world, and boast a staff of industry leading experts in the areas of technology and compliance.



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