Company Overview:
Industry: Agrochemical
Revenue: Over $7 billion
Employees: More than 15,000
Locations: 50+ countries
Business Challenge
A leading agrochemical company with a global presence in crop protection products, including insecticides, herbicides, and fungicides, sought an improved means of tracking, managing and controlling its product and technology registration processes to ensure
global regulatory compliance.
Initially, the company utilized a homegrown software application to track the registration of active ingredients used in its products. Active ingredient registration is a necessary component of regulatory compliance which can get very complex very quickly with multiple products being sold into multiple markets all of which must meet national, regional and local regulatory requirements.
By 2008, the scalability and performance of the company’s solution could not support the growing needs of the organization. They had outgrown the capability of its legacy tool and therefore sought a new scalable, centralized solution using industry best practices.
Ultimately their registration processes demanded a unified central view of its registrations and tracking activity to ensure compliance and sought such transparency as a means of streamlining control and visibility through a single enterprise solution.
Initially, the company utilized a homegrown software application to track the registration of active ingredients used in its products. Active ingredient registration is a necessary component of regulatory compliance which can get very complex very quickly with multiple products being sold into multiple markets all of which must meet national, regional and local regulatory requirements.
By 2008, the scalability and performance of the company’s solution could not support the growing needs of the organization. They had outgrown the capability of its legacy tool and therefore sought a new scalable, centralized solution using industry best practices.
Ultimately their registration processes demanded a unified central view of its registrations and tracking activity to ensure compliance and sought such transparency as a means of streamlining control and visibility through a single enterprise solution.
Solution
The company procured Sparta Systems’ Trackwise® Enterprise Quality Management Software (EQMS) and in January of 2012 they rolled out the new solution in order to:
- Track and improve compliance of federal registrations
- Track registered manufacturing sites by country
- Utilize data from their internal system
- Leverage existing documentation and reference data systems
- Ensure a strong link between registered product and its corresponding product launch
The new TrackWise solution enabled the company to leverage existing documentation of stored registration data without causing major
disruption and eliminated the inefficient and error-prone work practices of manual data entry and management. In addition, TrackWise
provided a dynamic link between product registrations, and the corresponding product launches and business units that needed to
view them, ensuring that only compliant registered products enter the marketplace.
Conclusion
Overall, the company was able to centralize and consolidate their registration tracking data for regulatory compliance and business
process improvement. The organization improved its compliance and audit preparation for better traceability by combining automated
processes and best practices for product registration tracking. Senior management finally achieved complete visibility into regulatory
compliance status across the enterprise.
Improved Registration Tracking - while the full results of the implementation are still being analyzed, tangible results are expected in
the discrete registration tracking of their products and vigilance of their regulatory compliance. In addition, TrackWise enables tracking
of registered manufacturing sites which is required by regulatory authorities.
Reduced Inefficiencies - the new solution enabled the company to leverage existing documentation of stored registration data
without causing major disruption. The new solution eliminated the inefficient and error-prone work practices of manual data entry
and management. In addition, TrackWise provided a dynamic linkage between product registrations and the applicable sales units and
enterprises that needed to view them, ensuring that only compliant registered products enter the marketplace.
Better Visibility - TrackWise allowed the company to easily view their compliance status, and quickly query if, and where, they might be
out of compliance so the issue could be quickly resolved.
This leader in the agrochemical industry has realized the benefits of TrackWise as a fully integrated quality management system. With
initial help from Sparta Systems’ professional services team, the company used a flexible, systematic approach for reviewing its existing
paper processes and implementing TrackWise features to automate and streamline operations, while at the same time achieving
complete control across the enterprise. The TrackWise platform has resulted in a centralized system to manage product registrations at
the country or regional level and extract application information to perform required assessments. TrackWise also enables the company
to effectively manage the new product introduction process to ensure timely completion of key activities through the entire product
life cycle. Managing audits and tracking finding associated with stewardship audits and field inspections allows the company to capture
non-compliant responses and develop corrective actions to support compliance efforts