Single vs Multi Tenant Systems in Serialization – What does the law say?

Data Matters in Serialization (Part 2 of 6) – Single vs Multi Tenant Systems in Serialization

Serialization experts often get asked to clarify the difference between Single vs Multi Tenant Systems in Serialization solution providers and why should companies invest in one system over another. Mark Davison, EU based serialization expert, discusses, Single vs Multi Tenant Systems in Serialization, the differentiators between serialization and track and trace solution providers.

To make a truly informed decision about solution providers, companies need to understand and plan out their requirements from the beginning. For example, Pharmaceutical companies need to ensure that the solution they purchase is validated with EU Annex 11 and 21 CFR part 11 for the the U.S. Drug Supply Chain Security Act (DSCSA) or the E.U. Falsified Medicines Directive (FMD) respectively. Pharmaceutical companies must also ask whether their suppliers can validate their system and ensure compliance. Companies need to ask solution providers; how will they ensure to be compliant? Do they follow industry standards? Is the system stable in the long run? Will they be there to support and carry the validation burden?

Typically, these systems will boil down to two different options for a solution provider to host and manage your system:

  1. A single tenant system which is under a private cloud where there is a single product instance that companies control and decide when and how it is updated. This also allows the company to customize its features according to its requirements and needs.
  2. A multi-tenant system which is under a public cloud infrastructure, where a company shares the environment with other companies and the solution provider decides when that environment is updated and patched. Companies don’t have any control over when to accept product changes and updates. Meaning the system can be down at any moment and without any backup.

From our experience here at rfxcel, validation engineers in the pharmaceutical serialization and track and trace industry want to control the environment quite tightly.  So having the choice of how and when to do that is very important for your journey to meeting compliance requirements.

Here at rfxcel, we believe that the customer should be in control. They should have the ability to decide how to lock down the system, and when to to make and document changes. This is important because in the end, it will be up to them to prove to the regulators who, when and how they do business. And with total control over the data, companies can pull the needed information for audit.

Think of what hoops your company has to jump through with regulators to make sure you get what you need out of the system to ensure patient safety and maintain data integrity.