CASE: From Implementation to Validation in 6 Months

Learn how PolyPeptide, with Epista and Implema, created a regulated, global, & transparent platform

Polypeptide Group specializes in peptide manufacturing for Pharmaceuticals and Biotechnology. The group is the world’s second largest producer, with production in Belgium, France, India, Sweden, and the United States. To create a cohesive system for reporting, processes, and meeting the demands of regulatory compliance, Polypeptide chose Implema and Epista Life Science as suppliers.

As the various plants worked differently and had different IT systems, Polypeptide was searching for a common and transparent platform that would unite commercial, logistic, and production processes and reporting. In addition to gains in efficiency, a standardized solution is almost a prerequisite in order to comply with regulatory requirements for companies in the Life Sciences.

Standardized Solutions for ERP and Quality
Implema and Epista Life Science are two companies that specialize in efficient implementations of ERP (Implema) and IT validations, operations, and quality in the Life Science industry (Epista Life Science). In order for Polypeptide to savely and effectively live up to regulatory demands, Implema and Epista offered a solution based on Dynamics AX, powered by Microsoft Azure. The implementation covers finance, supply chain management, purchasing, sales, quality management, project planning, and production.

Implema focuses on short-term projects with standardized solutions, bringing in the best possible experience within Life Science. Epista Life Science is a leader in the Nordic region, continuously improving regulatory compliance through proven methods for bridging the gap between QA (quality assurance), IT, and the various business processes. 

“We chose Epista and Implema for their competence within Life Science, quality requirements and validation, and effective implementations of standard systems.”
– Jan Fuhr Miller, CFO Polypeptide Group

“We wanted to keep standard functionality as much as possible for our processes in the supply chain, financial reporting, and production. From Implema, we received good guidance as to how we could resolve the various steps and processes, which was largely about changing our internal routines to the system, and not the other way around. With help from Epista, we have managed to bridge the gap between IT and business processes while simultaneously ensuring documentation requirements" explains Jan Fuhr Miller.

New Implementations Without New Validations
By running the business system project in a short period of time, Polypeptide succeeded in replacing the current platform in Malmö within six months, as well as creating a global platform to act as template for the other facilities, without disregarding the regulatory requirements. 

“The project in Malmö is definitely a success. The number of implementation days dropped from 400 in previous preliminary studies to about 80, and we experience a high degree of flexibility at Implema when, for example, we need extra resources,” says Jan Fuhr Miller.

The plan is that the new system and processes will be rolled out in all facilities by 2018.

Polypeptide, with the help of Implema and Epista, now has a common platform and a common approach that will cope with inspections from regulatory authorities and customers, and additionally can be implemented in other facilities with a much smaller validation effort than before. This, of course, saves valuable time, both in terms of management and implementation, as well as creating good conditions for the effective development of Polypeptide Group business.

“The number of implementation days dropped from 400 in previous preliminary studies to about 80, and we experienced a high degree of flexibility with both Epista and Implema.”
– Jan Fuhr Miller, CFO Polypeptide Group

Solution for Polypeptide Group:
- Platform: Dynamics AX via Microsoft Azure
- 6 months implementation time
- High level of standard functionality decreased adjustment volume
- Global, transparent platform for common processes and working methods
- A solution that lives up customers and authorities needs and requirements for inspections, and which can be implemented without revalidation

Questions about our work with PolyPeptide or how you can advance compliance in your own company? Contact info@epista.com