24-26 February 2021
Over the last 2.5 year, since the US-FDA announcement about CSA - Computer Software Assurance - many people and organisations in the industry speculated regarding the way to decrease the needed compliance work and starting to advocate for "critical thinking". Even if its publication was announced several times, the expected Guidance for Industry is still not available today.
Nevertheless, this situation should in no way lead the industry to encourage technological and digital immobility, but rather to rigorously plan necessary evolutions in well considered manner. The regulated users have to find adequate answers for many challenges regarding the required digital transformation: e.g. from electronic document workflow using electronic signatures until the implementation of artificial intelligence and Pharma 4.0 solutions, over better integration of automation in both production as well as laboratory areas and the use of Agile project approaches.
With its Position Paper on CSA, GAMP Francophone considers that both the current European GxP regulatory framework as well as the available industry guidance such as GAMP® 5 and the related Good Practice Guides propose already a large space for applying "critical thinking" within the scope of a sound science-based Risk Management for efficiently achieving GxP compliance.
Beyond the regulatory requirements alone, it would be regrettable if the industry, through ignorance of the regulations in force and a lack of questioning, would be its own obstacle to innovation and improvement.
Author: Yves Samson