Medical gums manufacturer Fertin Pharma has gone live with FDA-validated ERP technology from Microsoft at its medical gum manufacturing plant in Denmark. Brian Tinham reports
Medical gums manufacturer Fertin Pharma has gone live with FDA-validated ERP technology from Microsoft at its medical gum manufacturing plant in Denmark.
It’s the first to implement Life Sciences for Microsoft Dynamics AX – aimed at helping Fertin meet the tough regulatory requirements of the US Food and Drug Administration.
This is a full new ERP installation, following what’s been haled as a great success with standard Microsoft Dynamics Axapta at Fertin’s sister company Gumlink’s plant, which produces regular chewing gums. Payback on the total investment at that plant was within 10 months, according to Søren Seerup, senior vice president of IT at Fertin Pharma.
He says productivity doubled, inventory reduced from DKR 26m to 10m and workforce was reduced by 36%.
He expects similar savings from the new system at Fertin – automating back-office processes, reducing plant and production costs and optimising quality control. Ultimately, Fertin’s supply chain will be integrated throughout the medical chewing gum product life cycle.
The new system specifically includes functionality to comply with the FDA’s 21 CFR Part 1, ensuring that electronic records and signatures flowing through the organisation are auditable. Fertin also expects to benefit from the validated documentation software module, covering specifications and quality attributes on sopme 35,000 documents.
“We wanted the technology to be precise and customised specifically for the pharmaceutical industry and, more importantly for us, for medical chewing gum manufacturing,” says Seerup. “This was the first time we were able to put on a PC a large-scale manufacturing solution that was cost-effective and very easy to integrate with existing systems.”
It’s been a joint development. “Together we have been able to develop a solution that will help the entire pharmaceutical industry to undertake regulatory validation processes with greater ease,” says Rüdiger Dorn, industry lead at Microsoft EMEA for process industry.
“In the past, life sciences manufacturers would have spent significant sums to gather the necessary validation documentation to meet the requirements of the FDA and other regulatory bodies. With Life Sciences for Microsoft Dynamics AX, Fertin has been able to validate its processes quickly at a much lower price point.”