A Systematic Approach for Identifying and Reducing Gaps Between the Pharma and Software Industry and Transforming Quality through Digitalization in the Pharma Industry

Digitalization of data into electronic formats can transform the efficiency of an organization. Advances in software programming have enabled seamless conversion of manual workflows into electronic processes. We have described our experiences in the development of reliable and robust inter-connected electronic systems. In this article we have addressed the challenges in the development of electronic laboratory notebook software that follows a workflow in a biological laboratory. These challenges include: (i) linguistics: translation of ‘language of the scientist’ to the ‘language of the software designer’ and to the ‘language of the programmer’, (ii) limited knowledge of capabilities and limitations of technologies on either side (scientific and software) and (iii) lack of communication and documentation practices for capturing the requirements. Data integrity is the central regulatory requirement to a quality management system. Digitalization can address this challenge by addressing three major advantages – standardization of processes, increased compliance and enhanced efficiency. The observations made during the development processes of the present study can be applied to scientific software development and increasing requirements for collaboration of diverse cross-functional teams.