In light of the COVID-19 pandemic, too low levels of adopting a digital strategy in the pharmaceutical industry and the prevalence of paper-based processes in the validation of applications and processes , GAMP Francophone, has published a position paper on US-FDA’s initiative on CSA – Computer Software Assurance. The CSA is a prioritized guidance document, intended to be published in FY2021by the FDA. The new guidance is intended to shift the focus of the document-oriented computer validation towards a risk-based, critical thinking approach.
The position paper observes that the practices in the healthcare industry “show a certain difficulty, or even inability, to take advantage of technological developments and alternative project management approaches”
The paper stresses the importance of not immobilizing the technical and digital evolution while waiting for FDA’s new guidance document on CSA– but meticulously plan for the anticipated progress and take the opportunity to invest in the understanding of new technologies. It also underlines that the current European regulatory framework “through its systematic consideration of quality risk management”, currently do provide generous amplitude for implementing new and innovative approaches and that GAMP5 in a similar manner encourages creativity and efficiency in their industry practices.
As a company developing digitized compliance solutions to the pharmaceutical industry which will be validated, we are certainly looking forward to the published guidelines.