The pilot is aimed at organizations who are seeking a principled and risk-based approach to managing legacy software in order to support long-term data integrity and adhere to ALCOA+ principles. With secure and validated software installations, they can ensure that dynamic archived data remain usable and interactive for as long as needed.
Pilot duration: 8 weeks Pilot dates: 20 January to 30 June 2024 Latest start date: 1 May 2024
Each pilot participant can select a legacy software of their preference to be installed within the INTACT Software Library platform and used through secure remote access.
Following the recent release of OECD guidance Number 22 on GLP data integrity, organizations are revisiting their archiving practices. The guidance advises that both digital data and the corresponding software should be retained to support the reconstruction of studies and interaction with dynamic data.
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Format of pilot:
IT services & support
3 weeks Computing environment set up and software installation on INTACT Software Library platform
1 week Software evaluation and use for a specific business case
4 weeks Unlimited use of the installation for 10 users.
Compliance consultations
Creation of IQ, OQ, PQ for the software installation within the Software Operational Environment (SOE)
Development of SOPs for the software transition to the SDE.
Free training for the platform and SOE use and compliance consultations.
Infrastructure & licenses
Free INTACT Software Library infrastructure use for 8 weeks.
For public participation, the infrastructure use and licenses may be extended beyond the 8-week period to support cohort activities.
Further details:
Eligibility. Pilot is open to all organizations and individuals with genuine interest in long-term software care and with software hosting needs that fall within the scope of the pilot.
Engagement framework. Participation will be provided with a pilot SLA to cover the management of the software installations and the use of software licenses needed to use software.
Application process. Applications will be processed in the order they are submitted and until the pilot capacity is reached.