Within the pharmaceutical industry, a large number of written instructions are used describing work stages and processes to be executed in a uniform manner. These are produced in order to manage, monitor and control the quality of production.

There are examples of processes for dealing with deviations in order to ensure that preventive measures are implemented to prevent their repetition. Kemwell previously used a number of entirely separate systems for quality control; these were both IT-based and manual, paper- based systems.

The handling of processes takes a long time and the cGMP (Current Good Manufacturing Practice) framework imposes increasingly complex demands on production. In order to improve process efficiency, Kemwell determined to automate documentation management and work processes. Kemwell looked for an IT system which could handle documents and work flows and which could be used easily by everyone in the organization. Furthermore, the company required the system to follow the cGMP framework with a demand, amongst other necessities, for electronic signatures. Another requirement was the provision of support to other, future processes, for example event reporting, suppliers' contracts, help desk functions and project documentation.

“We saw that we could enhance the efficiency of the paper-based administration by making it electronic. This may, for example, mean rapid access to documentation for equipment and processes, or improvement work through being able to quickly identify deviations in a certain machine, or the production of key ratios for our quality processes.” notes Katarina Holmström, Senior Quality Professional at Kemwell.

Specialist competencies

Many work process stages require specialist competencies which need to be documented. This may refer to instructions for everything from how to clean a certain machine to all of the aspects that are to be checked prior to a product leaving the factory. Instructions must be kept updated and, in order to compare details, the personnel concerned must have either read the instructions, or have received the relevant training including the instructions. This is something which has traditionally taken a lot of time from operations.

Solution

Platina QMS proved to be a system that met all of Kemwell's requirements and requests. By making quality processes electronic, it is easy to see, for example, who has the authority to do what, and to see that documents and instructions have been read and electronically signed, with full traceability. In 2011, Kemwell worked to complete the final aspects of Formpipe's product implementation, a product specially developed to meet life science requirements.

“All in all, good IT support is provided in that we can quickly and easily produce the details evidencing that we have control of our processes and that our employees have the right training for their duties regardless of whether we, ourselves, our clients or a supervisory authority are requesting the information. Furthermore, access, maintenance and administration of management documents are carried out more rapidly.” states Katarina.