Pharmaceutical companies are confronted with policies, regulations and standards with regard to quality assurance. Local, national or global guidelines are used to meet these requirements. The Pharmaceutical Quality System is the basis for ensuring compliant, effective and efficient processes for managing changes that are relevant to those guidelines. The automation of operational process steps to manage the mentioned changes is increasingly demanded by the industry.

The methodology described uses a life cycle approach to discover, analyse and redesign the process in scope. Based on a guideline, several survey rounds and expert interviews were conducted with internal (operational) staff and employees who were either directly involved in the given business case or otherwise related to the topic. The analysis of the as-is situation describes the outcome for the redesign phase, which is based on continious process improvement.

Due to the business case and evaluated as-is situation, Robotic Process Automation (RPA) is the chosen solution, which best covers the given parameters. RPA can be introduced iteratively or systematically without endangering the existing functioning business process and can be tested in advance. RPA is ideal for the integration of a single user, the tool runs on the local machine and no administrator rights are required to install, run or maintain the application. A deployed robot is able to interact with different programs and to switch windows, which makes it convenient for the user to concentrate on one tool or to continuously expand it instead of having to manage one solution per application. The tool itself is rather intuitive and of low to medium technological complexity, but with the remark that depending on the complexity of the business process involved, some advanced technical knowledge may be required. In addition, the provided result includes a prototype for the client to demonstrate the automation of a process step as proof of concept.