“Quality by agility” was the theme of the International QA Conference 2021, 3-5 November 2021, attended by 350+ attendees online. The conference was organized by the Research Quality Association (The RQA) and included a varied programme of plenary sessions and parallel streams in GxP, IT, Pharmacovigilance, Animal and veterinary products, QA Clinics and more.
On Thursday, 4 November, the programme included an expert session on “Long-term digital data management and GxP compliance” with presentations by Matt Hansen from Labcorp Drug Development and Natasa Milic-Frayling from Intact Digital Ltd, followed by a round table discussion including Julien Marchand, Ferring Pharmaceutical. The session was hosted by Cate Covington, the Knowlogy Group.
Natasa’s presentation focused on practical aspects of implementing OECD guidance (released 20 Sept 2021) on long-term archive readability (section 6.16 Archive) that involves maintenance of legacy software in virtual environments. She demonstrated the use of virtualized software through secure virtual desktops to support reconstruction of research studies that are decades old.
The panel discussed processes and practices in software and collaboration with technology vendors to remove obstacles for achieving required longevity of research data and reliable validation of research results.
