Adapt tens of thousands of labels to the current regulations within the shortest possible time – that was the challenge issued by one of ARCONDIS’ customers, a major international medical device manufacturer. This was preceded by an audit, which called for a correction of the labels via a corrective and preventive action (CAPA).
The customer’s correction process required a comprehensive manual adjustment and quality check of the label texts. Since this task could not be fulfilled with their own resources, ARCONDIS quickly jumped in to ensure that the customer would meet the CAPA deadline. To support the labeling department, a consultant who was very familiar with the company was able to use a flexible resource plan from a parallel project for this time-critical project.
Time saving of 50 % through semi-automatic data validation
ARCONDIS quickly familiarized itself with the manual process and recognized the potential for significant time savings and quality improvement through partial automation using an Excel alignment. After this solution was successfully tested verified for compliance with the change process, it was possible to semi-automate the manual step of data validation.
After just one week – instead of the planned three months – the ARCONDIS consultant returned to his original project.
With his determined and savvy service, he made another customer his fan.
Thanks to the Excel tool, the required label text changes can now be prepared quickly quicker and with very few resources. The time saving compared to the manual work amounts to more than 50 %, so that in the present case the customer-internal resources were able to process the CAPA independently and in a timely manner.
Moreover, the customer is now well prepared for the new Medical Device Regulation (MDR) that applies in the member states of the European Union, which will further tighten labeling requirements for labels with the introduction of the “Unique Device Identification (UDI)” system (for more on this, see the article MDR UDI, UPDATE issue 01|2017).
■ Lars Schmiedeberg