A network of NMVO’s (National Medicines Verification Organisations), linked together in a hub led by EMVO (European Medicines Verification Organisation), is tasked with ensuring that the medicines distributed and sold in Europe are legitimate. Our Swedish NMVO is called
e-Verifikation in Sweden.
The Falsified Medicines Directive
To comply with the Falsified Medicines Directive (FMD), the pharmaceutical industry established EMVO with the mission of building and operating a European database for storing logistics and packaging information, as well as serving as a gateway between manufacturers and the national NMVO systems.
The Customer Group
The national organizations are responsible for ensuring that medicines on their respective markets are genuine and for creating the conditions necessary to investigate suspected falsifications. The collaboration currently includes all EU countries as well as those in EFTA. 15 of these national organizations work closely together, as their databases are structured in the same way and developed by the same provider.
Collaboration and synergies
The pharmaceutical industry is characterized by high requirements that European and national regulatory authorities expect the pharmaceutical companies to fulfill. This affects quality management systems (QMS), which must, of course, be tailored to both the business and the requirements imposed.
“We found that our QMS grew almost exponentially over time and as our number of employees increased. Eventually, it simply became too cumbersome to conduct periodic audits, send out reminders, set up training matrices, and perform other tasks manually,” says Kristina von Sydow, General Manager at e-Verifikation in Sweden (e-Vis) and the project’s client.
Kristina began as CEO at e-Vis in 2019 and realized early on that an electronic management system—a so-called eQMS—would be beneficial. The same experience and line of thinking also emerged among the other national organizations, which until then had been using standard Microsoft Office tools such as Excel and SharePoint.
“The Microsoft Office tools worked well, but control wasn’t particularly good unless you made a lot of custom settings—which most people didn’t do. Anyone who wanted to keep track of the documents had to manage Excel files, which was cumbersome. And creating reports or conducting management reviews involved a lot of work,” Kristina recalls.
Business processes within the national organizations are, for the most part, so similar, they could benefit from sharing a common eQMS system. This would also make the costs of development, implementation, validation, and licensing affordable.
“We are 15 national organizations with an average of four to five employees each, so as a group we are a small to medium-sized organization. It would therefore be worthwhile to jointly procure a slightly larger system and have a couple of administrators serve as superusers at the European level,” says Kristina.
The selection of CANEA ONE as an eQMS
It soon became clear to everyone involved that they needed an IT solution structured in the same way as a system for a corporate group with several subsidiaries. Furthermore, there had to be strict separation between the data in the respective countries’ IT systems. In addition, it needed to be cloud-based and have data storage within the EU to comply with the requirements of the GDPR.
“I started by Googling terms like ‘cloud-based QMS systems’ and very quickly came across search results from major providers whose solutions were geared more toward giant pharmaceutical companies, than a group of collaborating small businesses. And it would have been too expensive”, says Jan Van Loon, Quality Assurance at NMVO SolidSoft Customer Group, and continues:
“There were a few smaller providers, but there was always some sort issue with them. Either their systems provided a poor user experience, or their solution was essentially just an enhanced version of Excel.”
Jan and the customer group hired an external consultant to investigate the CANEA ONE system and were very pleased with the results.
“CANEA’s biggest advantage was how you handle your customers. You’re helpful and respond quickly when we need assistance, which isn’t the case with all competitors.”
“In addition, CANEA store its data in Europe, whereas other companies send it to the U.S., which creates additional risks related to GDPR. We wanted to avoid the effort associated with creating these risk assessments and mitigating actions.”
Almost all NMVOs have now implemented and are using CANEA Document. The customer group also purchased the CANEA Workflow module, since there are many processes—such as CAPA, defect reporting, change management, and access requests—that are easier to manage in a workflow than in a document.
There are still some things that need to be adjusted in the configuration of the document module. It turned out that users weren’t working exactly as initially anticipated.
“Of course, we must adapt the system to how people work, not the other way around. The great value of CANEA ONE is that it offers many options, and you can usually find a way to adapt the system to how users work,” says Jan.
The implementation project
The implementation project exceeded expectations, both in terms of quality and costs, which ended up about 20 % below the estimated level.
“The entire process, from start to configuration and validation, went smoothly. The system contains GMP-related data, and we needed to validate it. It was a requirement on our part,” says Jan, continuing:
“The NMVOs that have migrated the data from their old system to CANEA ONE say, after creating a few documents, that the system is intuitive and easy to use. They find the information they need without any trouble.”
Both Kristina von Sydow and Jan Van Loon give the implementation project top marks.
“I’m always a bit hesitant to give top marks, but I don’t know what CANEA could have done better in terms of implementation, configuration, and support. If I had a question or wanted to make a change, all I had to do was email your customer service team and get a response within a few days. You’re very flexible and accommodating. I’m very satisfied with how you handle your product and your customers,” concludes Jan Van Loon.
“You’ve been very responsive, proactive, and solution-oriented. My most memorable experience was when I had some feedback on the contract, and your consultant conveyed it to CANEA’s management and then came back with the news that our proposal was better and that we should go with it. CANEA gives the impression of being a learning organization, and that’s very positive,” concludes Kristina von Sydow.
The Falsified Medicines Directive
The European Falsified Medicines Directive (Directive 2011/62/EU) requires mandatory, harmonized safety features on all packages of prescription medicines for human use, with certain risk-based exceptions.
These safety features must consist of an identifier unique to each individual package, combined with a safety seal. Information about the safety features is stored in a database, and each package must be verified when dispensed to a customer or patient.
Pharmacies, wholesalers, and other entities that handle medicines must verify that medicines are legitimate before dispensing them to customers and patients.
“We conducted a supplier audit of CANEA during the evaluation phase and were very pleased with the results. That doesn't always happen.”
Kristina von Sydow, General Manager
e-Verifikation in Sweden (e-Vis)
