As a way of streamlining QA processes and keeping increasingly complex systems manageable, Chemika has implemented an electronic quality management system (eQMS).
Following vendor selection in 2022 implementation of the system commenced in early 2023. The system chosen was Dot Compliance.
The initial stage of implementation included only the document management and training modules. Uploading of the 650 documents to the system was carried out as part of the implementation work by Dot Compliance. Configuration also required preparation of a relationship matrix between all documents and this proved to be the most labour intensive part of the initial implementation.
In February 2023 the eQMS system went live and it became apparent very quickly that the productivity gains were very significant. The system has been steadily expanded in scope, progressing to being paperless.
Currently the CAPA, change control and investigational aspects of the quality system are in the final stages of implementation. Workflows will be automated and various QA activities integrated, including actions on internal and external audit findings.
Method validation and reporting will be managed by eQMS soon, making the task of the review of documents and protocols much easier and removing the need for collection of multiple pen and ink signatures. Customers will notice the changes in the eQMS generated reports, with electronic signatures in use, various minor format changes and hopefully also quicker issue of reports given the ease of management of reviews and authorisations.
In 2024 the system will be further expanded to include supplier qualification, instrument calibration and maintenance timetables in addition to instrument and computer installation and qualification.
Although the eQMS system components continue to be implemented, productivity gains are clearly apparent. Within a few months of system implementation the number of QA documents overdue for review fell to zero and the productivity gains have meant QA staff can devote time to improving systems since many of the menial routine tasks are no longer necessary. Although a significant investment of time was required in the initial stages, the work was all carried out by the Chemika QA team working with Dot Compliance and no additional resources were required.