Contract manufacturing company Kemwell decided to automate its documentation management and work processes and, in FormPipe Life Science's IT system, found a solution that could handle documents, workflows and training, and is easily used by everyone in the organisation.
Kemwell offers contract manufacturing of pharmaceutical products for global distribution. The company manufactures pharmaceuticals for five of the world's ten largest pharmaceutical companies, including GlaxoSmithKline, Johnson & Johnson, Novartis and Pfizer.
The group has more than 1,000 employees and seven production facilities. It is an approved pharmaceutical manufacturer for countries across the globe, including Europe, Japan, India and the US.
Kemwell previously used a number of entirely separate systems for monitoring, tracking and quality control using IT-based and manual, paper-based systems. Handling these processes and the associated paperwork is a time-consuming activity, time that could be better spent in the business and for compliance, with increasingly complex demands from current good manufacturing practice regulations.
In order to improve the efficiency of processes, Kemwell decided to automate documentation and case management processes. The company wanted one IT system that could manage documents and workflows alike. Furthermore, the system needed to be designed to enable compliance with Drug Applications and Current Good Manufacturing Practice, including electronic signatures. Kemwell also needed the system to support future processes such as incident reporting, supplier contracts, help desk functions and project documentation.
"We felt that we could improve the efficiency of our administration by moving from a paper-based system to an electronic system," says Katarina Holmström, senior quality professional at Kemwell.
"This would give us immediate access to documentation of equipment and processes. It would also allow us to develop our quality control activities further, for example, by easier being able to identify reoccurring problem areas for equipment or process, or by monitoring KPIs for our quality processes."
Kemwell decided to implement FormPipe Life Science, a fully integrated enterprise quality management software solution. The program, which has been specially developed to meet the requirements of life sciences companies, met Kemwell's requirements and wishes in full.
By carrying out the quality processes electronically, the company is now able to monitor processes much more closely, in real time and have easily accessible traceability of documents, cases and training.
"All in all, FormPipe's software means that we can quickly and easily produce the details evidencing that we have control of our processes and that our personnel have the right training for their duties regardless of whether the request for information comes from us, our clients or a supervisory authority," says Holmström. "Not only that, but we are also able to access, update and administer management documents much more quickly."