Digital workflow guarantees maximum production reliability

Production protocols, which describe the manufacturing process in detail, are created in the Pharmacy Management System and contain relevant classification terms for each preparation, such as batch number, manufacturing date, active ingredients or processor. During archiving, DocuWare adopts these details as index terms and uses them as central parameters for the subsequent workflow to verify correct manufacturing. An initial check is performed by the production manager, a second by the quality control department. If the quality control department also confirms the correctness of the manufactured substance with an electronic stamp, a final release is made by a responsible employee. This guarantees the safety of the manufactured preparation. In this way, 50 protocols with several hundred pages are produced daily. There are also test results on the microbiological production conditions in the clean room. Commercial administrative documents from order processing or ordering and accounting are produced at the Berlin headquarters. For reasons of data protection, these documents are stored and processed in a separate archive and separate from the patient and product information of the Donauwörth production site.

Adding mobile workflows

Based on their positive experience, the company is continuously identifying new areas to use digital document management, for example in the area of "mobility". The aim is to define workflows to enable stamp-controlled approval processes to be carried out at any time and from any location via mobile devices. The time-critical delivery of preparations should thus be ensured. There is also potential for optimization in the area of production-accompanying documentation of clean room conditions, the so-called laboratory logbook. Many parameters are currently still recorded here on paper. The development of a digital form and its linkage with the production protocols is now on management's to-do list.