Kemwell has signed an agreement on the ECM product FormPipe Platina to ensure management of the documentation for manufacturing and testing, and support for business processes such as alteration and deviation management. Total order value amounts to 1.6 million SEK to FormPipe Software. FormPipe Software's partner Sigma is in charge of the deal and responsible for the implementation.

Kemwell Group is a leading contract manufacturer of pharmaceutical products for global distribution. The company produces medicines for companies such as: GlaxoSmithKline, Johnson & Johnson and Pfizer.

“Our ECM products are widespread in the public sector; government agencies have rules and requirements, some of which are in level with highly regulated industries. This correlation has allowed us to work towards the pharmaceutical industry which has especially high quality requirements. As a result of the transaction with Kemwell we have obtained a quality label that stands high in the pharmaceutical industry”, says Christian Sundin, CEO of FormPipe Software.

“A qualified IT platform that combines the control of records by automated processes provides us with efficient workflows. This allows us to streamline and reduce lead times while ensuring that the regulatory requirements are complied with”, says Katarina Holmstrom, Quality Specialist at Kemwell.

In the pharmaceutical industry quality control is rigorous and concerns all parts of the organization, from research and development to manufacturing and distribution of drugs. Work within production and quality are being controlled by the pharmaceutical industry's stringent quality standards and Good Manufacturing Practice (GMP). National drug authorities carry out inspections to ensure the compliance with GMP. The best known authority within this field is the U.S. Food and Drug Administration (FDA). Dealing with highly regulated processes also puts high demands on the IT support which must live up to these same high GMP requirements.

“Sigma has an extensive and solid knowledge in effective information management and has previously worked on implementation projects in the pharmaceutical industry. We see that FormPipe Platina can provide significant customer benefits when talking about control, quality and efficiency in the pharmaceutical industry”, says Michael Lauridsen at Sigma.

For further information
Christian Sundin, CEO of FormPipe Software AB:
+46705-67 73 85
Michael Lauridsen, Sigma:
+46706-95 9514
Katarina Holmstrom, Kemwell AB:
+4673-8078457