Life Science: from ERP Implementation to Validation in Six Months

Polypeptide Group specializes in peptide manufacturing for pharmaceuticals and biotechnology. The group is the world's second-largest producer with manufacturing facilities in Belgium, France, India, Sweden, and the USA. To create a group-wide system for reporting, processes, and regulatory compliance, Polypeptide chose Implema and Epista Life Science as suppliers.
Companies
Polypeptide Group
Business Systems
Microsoft Dynamics / Life Science Epista
Sector
Life Science

From ERP implementation to validation in six months. The different facilities worked in different ways and had different IT systems. This drove Polypeptide to seek a common and transparent platform that unites business, logistics, and production processes as well as reporting.

In addition to the rationalization benefits that a standardized solution provides, it is almost a prerequisite for being able to comply with regulatory requirements for companies in Life Science.

Standardized Solutions for ERP and Quality Requirements

Implema and Epista Life Science are two companies that specialize in efficient implementations of business systems (Implema) and IT validations, operations, and quality requirements in the Life Science industry (Epista Life Science).

To enable Polypeptide to safely and efficiently meet regulatory requirements, Implema and Epista offered a solution based on Dynamics AX running on Microsoft Azure.

The implementation includes finance, supply chain management, purchasing, sales, quality management, projects, planning, and production.

Implema always focuses on short projects with standardized solutions to the greatest extent possible and experience in Life Science.

Epista Life Science is a Nordic leader in continuous improvement of regulatory compliance. This is achieved through proven methods for bridging the gap between QA (quality assurance), IT, and various business processes.

We wanted to stick to standard functionality as much as possible for our processes in supply chain, financial reporting, and production. From Implema we received good guidance on how we could solve the different steps, and the process was largely about changing our internal routines to fit the system rather than the other way around. With Epista’s help, we have successfully bridged the gap between IT and business processes while ensuring documentation requirements, says Jan Fuhr Miller.

New Implementations without New Validations

By running the business system project in a short time, Polypeptide managed to replace the current platform in Malmö in six months. They also succeeded in creating a global template for other facilities without compromising regulatory requirements.

The project in Malmö is definitely a success. The number of customization days dropped from 400 in previous feasibility studies to about 80. With that, we experience a high degree of flexibility from Implema when we need extra resources, for example, says Jan Fuhr Miller.

The plan is for the new system and processes to be rolled out at all facilities by 2018 at the latest.

Polypeptide now has, with the help of Implema and Epista, a common platform and a common way of working. This can handle inspections from relevant authorities and customers and can be implemented at other facilities with only a minor validation effort.

This obviously saves valuable time both in terms of management and implementation. It also creates good conditions for efficient development of Polypeptide Group’s business.

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