Orion is a Finnish pharmaceutical company—a builder of well-being that operates worldwide. Orion develops, manufactures and markets human and veterinary medicines as well as active pharmaceutical ingredients. The company constantly invests in research and development of new drugs and treatments. The core therapeutic areas of Orion’s pharmaceutical research are neurological diseases, cancer diseases, rare diseases of the Finnish genetic heritage and respiratory diseases, for the treatment of which Orion develops inhaled lung drugs under the Easyhaler® device portfolio.
Orion is a medium-sized business with annual net sales of about 1 billion euros. The company has operations in 27 countries, with manufacturing and head operations located in six different sites in Finland. It has a wide product portfolio and a large supplier network.
THE OPPORTUNITY: Making the Journey from Paper to Digital
Before implementing TrackWise Digital, Orion worked mainly with paper-based processes. All changes and audits were documented using spreadsheets and Word documents. Deviations, complaints, corrective and preventive actions (CAPA) and reclamations were created in its ERP system; however, there were no automatic process flows—this relied on emails sent back and forth.
Saku Tuominen, Orion’s Quality Assurance Specialist, says “this caused us a lot of challenges, like an inefficient way of working, lack of transparency and long lead times.”
The company’s quality management data was scattered and reporting capabilities needed improvement. Orion had a variety of software solutions in use for managing its quality management needs and was relying on communication via email between responsible parties and the organization.
“We needed to simplify the process and make it more transparent,” says Tuominen.
These challenges with quality processes triggered the need for Orion to evaluate potential quality systems that would help the company improve compliance, efficiency and data transparency for selected business processes.
Due to the wide scope of these processes, Orion determined that a single platform solution would be the best fit for the purpose— and that TrackWise Digital would meet this need.
THE SOLUTION: A User-Friendly, Holistic Quality Solution
Orion started the evaluation process in 2018 in which the company shortlisted three systems for further evaluation. The evaluation was carried out using various methods such as multiple demonstrations, reference visits and conducting an onsite proof of concept.
Orion selected TrackWise Digital due to its strong market share in pharmaceutical companies, usability, its reporting capabilities and best practice processes.
“We understood that TrackWise Digital was used by many, many pharma companies and that was a good thing,” says Anu Linna, Compliance Manager, Supply Chain & Procurement, at Orion. “Also, the user friendliness of the system was very good and the system also had the best practice processes available.”
Key Business Processes: The implementation of the TrackWise Digital system was done in two phases. During phase one, Orion implemented supply chain traceability, audit management and change management.
Phase two brought the implementation of deviations, customer complaints and corrective action. The system was implemented in all of Orion’s Finland sites as well as the India office. The company currently has about 750 users on the system.
Integration: Integrations were needed within several systems to streamline business processes and avoid multiple data entries. For example, Orion’s material data and batch related data is kept in its ERP system. Orion also needed to ensure that its quality system would integrate with its reporting system.
“It was very clear that we would need strong integration between this system in order to have deviation management working properly,” says Linna.
TrackWise Digital was able to fit those integration needs.
THE RESULTS: Improved Supply Chain Visibility and Supplier Qualification
TrackWise Digital has enabled Orion to achieve its goals. Linna says, “we managed to bring in the visibility to the supply chain, we can now say that we are fulfilling the GMP requirements and at the same time the overall management of supplier qualification method has enhanced a lot. And the reporting is in a much better level compared to the earlier manual excel-based process.”
Tuominen adds, “both Sparta and Orion were very committed to the project which enabled the successful implementation of TrackWise Digital to Orion.” Since implementing TrackWise Digital, Orion’s users have become familiar with the system and are reaping the benefits of an easy-to-use interface.
Greater Control Over the Deviation Process: Previously, Orion’s deviations were left open until corrective actions were ready. With TrackWise Digital, Orion can close the deviation after taking immediate action and follow up with long-term actions separately. As a result, Orion has gained greater control and visibility into all deviations. The company can now close those much faster than with its previous system, resulting in a 53 percent decrease in lead time.
Innovating Change Management: TrackWise Digital has also significantly simplified the change management process and increased transparency. Rather than sending email correspondence back and forth, Orion implemented an evaluation team approach in order to ensure a smooth process flow of changes and to provide visibility into all activities —including all open tasks within the change management process. The previous manual system did not have this capability. Now, Orion has the functionality needed to report on the results and has reduced the change management lead time by 9 percent.
Supplier Quality Management and Supply Chain Traceability: The pharmaceutical supply chain is very complex, global and tightly regulated. For Orion, that’s no exception with a complex product portfolio of hundreds of suppliers in the areas of finished products, API and excipients and packaging materials.
To meet this need, Orion was able to customize supply chain objects in TrackWise Digital to link suppliers with related materials. The supplier qualification process, which included supplier changes and reclamations, was implemented out of the box.
“These objects are working quite nicely together and bringing good visibility to the total situation of an individual supplier,” says Linna.
Since implementing TrackWise Digital, Orion has already completed its first upgrade and the company plans on further developing its reporting tools. “It is evident that compared to the earlier manual system, TrackWise Digital has increased the visibility and transparency in all processes,” says Tuominen.