European Bio Analysis (EBF) Open Symposium is organized annually to enable EBF members and a broader bioanalysis community to come together and share knowledge and experiences, discuss advances in scientific methods and technologies, and align their practices and responses to regulatory requirements.
In order to accommodate a broader participation and deal with impact of the Covid pandemic, 14th EBF Open Symposium includes two parts: in-person event in Barcelona, 24-26 November 2021 and online event, 1-3 December 2021.
Intact Digital took part in the event in Barcelona and contributed a poster presentation on “Implementing OECD Data Integrity Guidance: Maintaining legacy software in virtual environments to keep archived dynamic data GLP compliant”. The method was presented by Natasa Milic-Frayling.
Readability of dynamic digital data and reconstruction of research studies are key to transferring knowledge to future generations of scientists. That is particularly important in bioanalysis research which forms the foundation of our abilities to find cure and save lives. The latest OECD guidance (Number 22) advise organizations to maintain legacy software in virtual environments in order to ensure that archived data remains usable for as long as the data needs to be retained.
INTACT Software Library and its customization for GxP Labs provide a reliable software virtualization platform, specifically design to support hosting of legacy software installations. It includes services for installing, validating, hosting and monitoring software and mediating risks from technology obsolescence. The poster highlighted the Intact Digital principled approach to long-term management of legacy installations, considering 5 key aspects: technology, legal, operations, human factors and quality assurance.
“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.
International Conference on Digital Preservation iPRES 2021 is this year held as a hybrid event at the National Science Library in Beijing and on Zoom. It is co-hosted by the National Science and Technology Library (NSTL) and the National Science Library of Chinese Academy of Sciences (NSL).
Intact Digital paper on Executable Archives has been included in the main programme as part of the Paper Session 4 on Wednesday, 20 October 2021. The presentation discusses data integrity and software integrity requirements for the long-term preservation and use of archived research studies.
During the presentation, Natasa Milic-Frayling introduced the Executable Archive Framework and demonstrated how it informed the design of the INTACT Software Library, a software hosting platform and services that complement electronic data archives by providing validated installations of software for reliable readability of data and research study reconstruction.
On 21 October 2021, Members of the UNESCO MoW Preservation Sub-Committee, Ms Lai Tee Phang (Chair), Ms Natasa Milic-Frayling, Mr Robert Buckley and Mr Kevin Bradley are coordinating a panel on the “Digital Documenter Heritage: Securing Reliable and Sustainable Access”.
The panel is moderated by Ms Lai-Tee Phang, the Chair of the UNESCO MoW Preservation Sub-Committee, and includes experts in digital preservation and long-term access to documentary heritage:
With this iPRES panel, UNESCO MoW Programme continues a policy dialogue with the preservation community, focusing on issues of long-term and sustainable access to digital content. There are many challenges to safeguarding digitized and born digital content, including the continuous and rapid obsolescence of digital technologies. The issues are considered with the aim to identify policy interventions that UNESCO can facilitate.
In October 2020, UNESCO held a two-session Virtual Policy Dialogue (Programme) and in September 2020 released a report with main outcomes. Video recordings of the sessions are available on the UNESCOPERSIST Web site.