One of the biggest challenges in the field of Quality and Regulatory Intelligence for Life Sciences is that the majority of the data that needs to be analyzed is unstructured, which prevents objective, apples-to-apples comparisons. It comes from many different sources with many different structures. Then, when it gets pooled for aggregated analysis, the previous organizations don’t align. This post will take you through why Redica Systems created the Redica ID and the crucial role it plays, as well as compare it to the FDA Establishment Identifier (FEI).

Redica ID vs. the FEI

Universal, unique IDs play critical roles in many industries. Think of the U.S. Social Security number or the SWIFT/BIC codes for banks. They aid in entity resolution. Entity resolution has been defined as “a technique to identify data records in a single data source or across multiple data sources that refer to the same real-world entity and to link the records together” (source here).

ID vs FEI Figure 1
Figure 1 | Redica ID – Creating a single source of truth for Sites

For example, you may have various spellings of your name floating around. Some may include your middle name written out, some may include just your middle initial. Some may include just your first and last name. Your social security number helps to aggregate all of the permutations of your name into one known entity.

The Redica ID does the same thing. It resolves all permutations of a particular site, organization, product, or person, into one comprehensive entity. Not only does that clear up confusion about the various combinations, but it also empowers clear linkages between a site that manufactures APIs and the organizations that use that site in their supply chains, as one example.

Figure 2 | Redica ID – Links “everything to everything”
Aside from the Redica ID, the FEI is the closest thing the life sciences quality and regulatory world has to a unique ID. According to the FDA, “It is also known as the Firm or Facility Establishment Identifier. The FEI number is a unique identifier assigned by the FDA to identify firms associated with FDA regulated products.”

One important drawback of the FEI however is that it only pertains to FDA’s jurisdiction. That means that a particular site may have an FEI issued by FDA, but it may also have other IDs from other agencies around the world. There’s no way to match the FEI of a particular site to the ID number assigned to the same entity by a different regulatory authority or agency – until now.

We created the Redica ID to serve as the first truly universal, worldwide ID for these entities.

Another drawback of the FEI is that there are some entities that play important roles in the global life sciences supply chain that have not been issued an FEI by FDA. By comparison, Redica Systems issues a Redica ID to every entity in our large and growing global data set.

Linking Everything to Everything

Another huge challenge in conducting robust quality and regulatory analysis is that objects that are closely related are not connected in the data set. For example: if you are using the FDA Data Dashboard to access a particular 483, you’ll naturally have follow-up questions like:

Does the organization that received this 483 have any role in my supply chain?
Is the active pharmaceutical ingredient (API), excipient, or finished dosage form (FDF) that this facility manufactures also part of my supply chain?
Is this an anomaly, or part of a larger trend?

You can’t easily answer these questions using the FDA Data Dashboard. The 483 is made available in isolation.

On the other hand, with the Redica ID, you can see all firms, sites, people, products, documents, etc. that are associated with that particular 483.

Applying this to MedTech

MedTech has one additional unique identifier called the Unique Device Identification (UDI). We’ve written an in-depth post about UDI requirements here. They are issued by various agencies. The good news is that they are standard across agencies, meaning that FDA and EMA, for example, would both refer to the same UDI. To an extent at least. There are differences between regional UDI databases and policies and the global standards.

This is why Redica Systems also assigns a Redica ID to each UDI in our database. We go the last mile in creating a universal global ID system with no variation.

Conclusion

Unstructured data and data noise are two of the biggest challenges in conducting efficient Quality and Regulatory analysis for life sciences companies. Redica Systems created the Redica ID to finally solve this problem and the result is our Quality and Regulatory Intelligence platform.

While the FDA’s FEI is a very helpful identifier, there are some critical differences between the FEI and the Redica ID.

The most important differences between the Redica ID and the FDA’s FEI are:

Redica ID applies to entities outside of the jurisdiction of FDA
In addition to “Firms or Facilities”, Redica ID applies to entities like FDA Investigators, Products, Documents, and much more, whereas FEI only applies to Firms or Facilities
Linking between all of these entities and therefore highlighting the relationships is easier with the more robust Redica ID

Experience the power of the Redica ID in action by requesting a demo customized to your life sciences company today.