Kemwell Group uses Formpipe’s Platina QMS solution

products-servicesFormpipe

August 28th 2014

Case Study Overview

Leading CMO Kemwell Group needed to integrate and automate separate IT-based and paper-based systems for quality control at its Uppsala production plants in Sweden. At the same time it needed to comply with GMP regulations and create a ‘future proof’ system that would support incident reporting, suppliers’ contracts, help desk functions, project documentation and other projected applications. Implementing Formpipe Platina QMS to improve documentation and case administration provided the perfect solution.

Background

Kemwell contract manufactures pharmaceutical products for global distribution, with clients including 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, including two at Uppsala in Sweden.

Traditionally the pharmaceuticals industry has relied on page after page of written instructions to describe how the various work stages and processes are to be executed in a uniform manner.

The purpose of these instructions is to facilitate management and monitoring and to ensure that the quality of the production is sustained. In particular, these include processes for handling deviations and for ensuring that preventative measures are implemented to avoid any repetition of deviations.

Kemwell previously used a number of entirely separate systems for quality control, both IT-based and paper-based systems. However, it found manual handling of these types of processes increasingly laborious and resource intensive.

At the same time, the need to comply with current Good Manufacturing Practice (cGMP) regulations constantly increased workload and penalties for failure.

In order to improve efficiency, Kemwell decided to automate the documentation management and work processes at Uppsala, creating an integrated IT system that could manage documents and work flows and which would be easy for everyone in the organization to use. This system needed to comply with cGMP regulations, including the demand for electronic signatures.

Yet another requirement was that the system should be able to support other, future processes such as incident reporting, suppliers’ contracts, help desk functions and project documentation.

“We understood that we could improve the efficiency of our administration by moving from a paper-based system to an electronic system.” states Katarina Holmström, Senior Quality Professional at Kemwell.

“In doing so, we would have, for example, immediate access to documentation of equipment and processes, and we would be able to further develop our improvement activities with the possibility to quickly identify deviations in a particular machine, or by producing key ratios for our quality processes,” said Ms. Holmström.

Platina QMS Solution

Formpipe’s Platina QMS solution proved to be a system that met Kemwell’s requirements and wishes in full.

Conducting quality processes electronically via Platina makes it possible, for example, to identify immediately who has the authority for any specific task and to determine whether documents and instructions have been read and electronically signed, with full traceability.

During 2011, Kemwell worked to complete the final stages of the implementation of the Platina QMS solution, which has been specially developed to meet the requirements of life science.

The Platina design recognizes that many pharmaceutical work processes require specialist skills that need to be documented; ranging from instructions for cleaning machinery to checklists of all steps needed before a product is released to market.

Instructions must be kept up to date and, to ensure the proper execution of the activities, there must be confirmation that the personnel concerned have either read the instructions, or have received training in the described work processes.

This document management has traditionally consumed much time that could be better spent elsewhere in the business.

Platina QMS meets these needs with automated workflows that help to create, manage and connect quality related documents, records, cases and processes in ways that are impossible with manual paper-based systems, or stand-alone software solutions. Combined with the web-based and easy-to-use software, Platina delivers unprecedented levels of flexibility. As well as key compliance applications, the system can be used to manage any number of regulated or non-regulated documents, tasks and processes.

“All in all, a good IT support system means we can quickly and easily produce information which fully indicates that we have control over 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,” commented KatarinaHolmström.

Not only that, but we are also able to access, update and administer management documents much more quickly,” she concluded.

Benefits

In summary, benefits for Kemwell of working with Platina QMS included:

More efficient processes
Improved documentation management
Electronic quality processes allow users to quickly identify relevant authorities
Transparency on which documents have been read and signed off
Improved overview for simplified prioritization and shorter processing times
Quick administration of management documents