8 Criteria You Should Demand Before Choosing an ERP System for Pharma Logistics

Search for “the best ERP system for pharma logistics” and you’ll often find lists crowning a winner. But in an industry where regulatory requirements, product categories and business models vary significantly from company to company, it makes more sense to know the criteria you should use to evaluate vendors yourself.

Here are the eight that come up again and again when pharmaceutical wholesale and distribution companies choose a system.

1. GDP compliance built in

The first and most important question: Is Good Distribution Practice a built-in part of the system, or is it something that has to be bolted on afterwards through customisations and third-party tools? A system designed for GDP from the ground up significantly reduces both implementation risk and the ongoing maintenance burden.

2. Temperature control and cold chain documentation

Can the system log temperature data automatically, send alerts on deviations, and document the entire cold chain from warehouse to delivery? Ask specifically how the system handles an Out-Of-Specification (OOS) situation - from the moment a deviation is registered until it’s investigated and closed.

3. Serialisation and anti-counterfeiting

Does the system support serialisation requirements, including integration with national verification systems such as securPharm and MSV3? This is rarely something that can easily be added later - it should be part of the fundamental system architecture.

4. Audit trail and documentation

Can every action in the system be traced back to a specific person and a specific point in time? And - just as importantly - how long does it take to produce full documentation for a given batch or delivery if an authority such as the Danish Medicines Agency or the MHRA asks for it?

5. Risk and CAPA workflows

Does the system have built-in processes for handling deviations and corrective actions (CAPA), as well as ongoing risk assessment of transport routes and distribution partners? Or does this still happen in separate documents and spreadsheets that easily lose their connection to the actual events?

6. LIMS and quality integration

If you work with laboratory testing as part of your quality control, it’s essential that the system can integrate with a LIMS (Laboratory Information Management System), so that test results can trigger automatic holds or releases - without manual handoffs between the lab and the warehouse.

7. Scalability and multi-site/multi-client support

Can the system handle multiple warehouses, multiple countries with different regulatory requirements, or multiple contract customers if you operate as a 3PL? This quickly becomes a decisive factor if the company grows or expands geographically.

8. The vendor’s industry and regulatory experience

Does the vendor already understand GDP and GxP requirements, or will you have to translate regulatory requirements into concrete functionality yourselves during implementation? A vendor with deep industry knowledge reduces both implementation time and the risk that compliance gaps are only discovered after go-live.

How to use the criteria

Ask each vendor to demonstrate - not just describe - how their system handles each of the eight points. Points 1, 3 and 4 in particular are worth testing concretely, as they have direct consequences if a compliance issue or regulatory inspection arises.

If you need more detail on what these criteria look like in practice, feel free to have a no-obligation chat with us.