Pharma 4.0 – Part 2, the Double-Edged Data Sword

By:  John Niziolek
Associate Director, CSV
IPS-Integrated Project Services, LLC

This post is the second of a three part series exploring Pharma 4.0, its beneficial impact to organizations, and the additional steps necessary to maintain compliance with the new technologies.


One of the key benefits of implementing Pharma 4.0 technologies into your manufacturing process is the abundant volumes of data that can be potentially produced. With this newly created data about your process, you may have the ability to predict mechanical breakdown, more closely monitor product quality, and potentially have insight into areas where optimization can occur.

As you may have guessed from the title of this post, there are also several potential items to note regarding additional responsibilities and precautions you should take with your newly generated manufacturing data.

  1. Completeness and accuracy of data – The data generated should be concise and self-explanatory. You should determine if the new data objects generated can be understood independently of other related data.
  2. Increased overhead cost – While the cost of data storage has decreased dramatically over the last five years, one should consider the impact to budget as well as staff resources required to implement and maintain additional storage capacity.
  3. Security – For the most part, as long as one follows their current organizational IT security best practices, there should be little to no concern attributed to the increase in the volume of data. Take precaution when leveraging IIoT (Industrial Internet of Things) technologies. There have been several high profile malicious attacks on organizations implementing IIoT systems and technologies; it would be wise to educate and empower your support organization.

In summary one should embrace the opportunities provided by your newly generated process data, when wielded properly it can empower your organization, provide insight into new aspects of your business, and even decrease your overall spend.

In our final post we will summarize the impact Pharma 4.0 technologies will have on the future of manufacturing and how it will change the way we work.


Official blog of: INTERPHEX New York -
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