November 2017 marks an important deadline for pharma manufacturers who need to begin serialization all the way down to the item level. Yes, it may seem like a daunting task but delaying the inevitable can result in poor business decisions come crunch time.
Don’t let the pressure get to you. Start to evaluate your options today. The good news is that there is still time to find the right solution to fit your individual business needs.
If you are just kicking off your search, we have one piece of advice:
“Regulatory requirements are in constant evolution. Right now, pharmaceutical companies are focused on serialization at the unit, case, and pallet levels, but tomorrow’s challenge is still unknown. As businesses evaluate options to meet today’s FDA requirements, system flexibility should be top of mind. If the solution cannot react to changes quickly and with minimal disruption, then it will fail to support ongoing shifts in regulatory and industry priorities.” – Scott Deakins, COO of Deacom
This pharma serialization is not the first, nor will it be the last FDA change to pharmaceutical manufacturing processes. Therefore, the solution you deploy should be able to quickly respond to shifts in industry priorities.
Some clues of an inflexible ERP environment that could hinder development:
3rd Party Modules – If a solution relies on serialization, formulation, or other capabilities via an outside source, you’re bound for headaches. This ERP structure limits the control that the provider has on the functionality and its development, thus delaying or preventing its ability to keep up with industry standards.
Customization – This is only a quick fix. Customizations are often required to force a solution to meet specific customer needs. When system upgrades become available in this situation, it may not be compatible with the customizations that were put in place. In fact, it can cause communication breakdowns between technologies. This is a cause for concern when it comes to managing constantly evolving industry requirements. Instead, find one that allows you to configure the software, not customize it.
Old Technology – Stale, outdated technology can have limited capabilities for evolving and discourage employee adoption. Solutions with thin user interfaces and centralized business logic can react quicker to changes and be much more user-friendly. Also find one that provides mobile capabilities without the need for constantly syncing data.
So now is the time to put together your team and create a game plan for tackling the new serialization regulations that will not inhibit operations.
To find out more about how Deacom handles pharma serialization, click here.