Headquartered in Switzerland, Ferring Pharmaceuticals is a research-driven, specialty biopharmaceutical group active in global markets. With more than 4,000 employees worldwide, the company identifies, develops and markets innovative products in the areas of reproductive health, urology, gastroenterology and endocrinology. Ferring has its own operating subsidiaries in 50 countries and markets its products in more than 70 countries.

THE PROBLEM

As a life science company, computer system inventory and quality management were always of paramount importance for Ferring. As the company began to expand rapidly, it wanted to ensure that its methods for managing these processes would keep pace with both internal demands and external regulations.

To track these processes, Ferring had traditionally relied on Excel worksheets and paper files. However, this system quickly became outdated for a growing organization with multiple locations. Furthermore, Ferring found it impossible to identify trends or issues based on the data residing within it. The added pressure of compliance requirements, most notably 21 CFR Part 11, was another driving force behind the company’s search for a centralized, automated quality management system.

In 2002, Ferring took the first step towards transforming its computer system inventory and quality management processes when it sought a solution to automate its inventory tracking system

“We chose TrackWise because not only did the company demonstrate that it could fulfill everything we needed for our inventory tracking project, but it was configurable right out of the box. It was a solution we could easily and quickly expand for many years to come, as Ferring’s quality and compliance needs evolved,” - Flemming Simonsen, Global Quality Assurance Director, Ferring Pharmaceuticals

Selection and Initial Implementation

After receiving a demonstration of the TrackWise® Enterprise Quality Management Software (EQMS) as part of a formal vendor evaluation process, Ferring determined the solution possessed the scalability and flexibility the company needed to configure its inventory system to meet current and future growth. While Ferring initially chose the solution to automate its inventory system, Flemming Simonsen, the company’s global quality assurance director, anticipated TrackWise’s ability to act as a centralized system to automate a multitude of global quality processes across the enterprise.

The implementation of the inventory tracking system began in 2002. The team continued to work with Ferring to implement TrackWise for CAPA and complaint handling in 2003. After that time, Ferring has managed to update and expand the system – and train all of its end users – on its own, due to its highly configurable nature and ease of use.

THE RESULTS

Today, TrackWise is used across eight manufacturing sites, two development sites and 30 marketing and sales affiliates by 800+ employees. TrackWise provides Ferring with a centralized platform to manage and report on all of its quality processes, track the status of activities in real-time and identify and analyze issues and trends as they arise. Benefits include:

• Faster Turnaround Time for Complaints: The turnaround time for complaint handling has improved significantly. TrackWise has allowed Ferring to run a more streamlined and efficient complaint management and reporting system across the globe.
• Better Global Collaboration: Since multiple users, across multiple sites, have access to reports and data, there are more conversations, collaboration and efficiencies between locations. TrackWise provides Ferring employees with deeper visibility into areas that can be improved and more insight into how things are done at other sites.
• Deeper Insight for Marketing and Sales: Approximately 30 marketing and sales affiliates covering 50 markets use TrackWise to gain insight into customer complaints. Since TrackWise centralizes all of that data, the information is available to representatives in near-real time, enabling them to better meet the needs of customers and ensure a more collaborative work environment across the organization.
• Improved Compliance and Audit Preparedness: By ensuring that all quality data is logged and reported in a centralized repository, TrackWise provides a reliable audit trail – whether it be for third-party, regulatory, internal, customer or supplier audits. TrackWise has also helped Ferring keep better track of and evaluate its reportability for regulatory agencies, most frequently for 21 CFR Part 11.

Ferring Pharmaceuticals – 10 Years of TrackWise – 2002-2012

• 2002: Use of TrackWise began with the implementation of an inventory tracking system.
• 2003: Expanded its use of TrackWise to centralize and manage quality processes in a single system for the entire business; including customer complaint handling and Corrective and Preventive Actions (CAPAs).
• 2004: Introduced change control functionality and supplier quality management (SQM) capabilities.
• 2005: Ferring added deviation management to TrackWise and expanded the existing inventory tracking system to include maintenance calibrations. It also updated the supplier audit functionality.
• 2008: Added internal audit management to track regulatory inspections, customer audits, corporate audits and self-inspections. Ferring also implemented TrackWise for quality risk management.
• 2009: Upgraded change control application across multiple sites. They also created an incident management module called “Unexpected Events,” which captured all unanticipated incidents related to inventory and quality management processes across the enterprise.
• 2010: Upgraded the quality risk management process including detailed supplier audit data, to determine overall risk and how often suppliers should be audited.
• 2011: Ferring streamlined change control process to ensure all global change requests could be centralized.
• 2012: Ferring plans to upgrade its complaint management system and will also be implementing a new deviations process across the enterprise by year’s end.