Implementation of an Electronic Quality Management System using Q-Pulse: The KEMRI-Wellcome Trust Research Laboratories Experience

Background: The KEMRI-Wellcome Trust Research Laboratory’s expanded scope, its regulated environment coupled with the complexity of the laboratory processes and procedures to support diagnostic, clinical and basic research has made it difficult to manually manage its quality systems. We sought to automate the process to improve efficiency. Objectives: To implement a centralised electronic quality system using Q-Pulse. Methods: A concept note detailing the objectives of automating the laboratory QMS was developed. The implementation strategies employed included provision of technical support through installation, customization, training and data entry. Results: The system was successfully implemented in May 2017. Out of the 30 workflows created, 8 were for document module, 5 each for audit and CAPA modules and 4 each for people, equipment and training modules. A total of 140 laboratory staff were trained. Conclusion: The laboratory can now manage the huge documentation and there is reduced bureaucracy, increased efficiency and awareness.