The pharmaceutical sector increasingly uses digital technologies to support all aspects of the product lifecycle, from its conception and design to validation, manufacturing, servicing and disposal. However, with new technological advances and modernization of labs, old technology, particularly software, becomes obsolete very quickly. In particular, software becomes unusable and data inaccessible.
Software is needed for as long as data is retained. This has crucial consequences for access to electronic data that has been collected and analysed by computerized systems. Without software, data files cannot be opened and digital data cannot be read, processed, and interpreted.
GxP regulations require that data must be retained and that data integrity must be ensured throughout the product lifecycle. In particular, regulatory guidance from the OECD states that raw data collected from instruments during discovery and pre-clinical research have to be archived in their original form and used for reconstruction of studies during regulatory audits. Software obsolescence makes meeting the GxP regulatory requirements a challenge.
Number 15
Establishment and Control of Archives that Operate in Compliance with the Principles of GLP Introduction
The maintenance of the raw data associated with a specific study and the specimens generated from that study are the only means that can be used to reconstruct the study, enabling the information produced in the final report to be verified and the compliance with GLP of a specific study to be confirmed.
Number 17
Application of GLP Principles to Computerised Systems
3.2 Data and storage data
When a system or software is updated, it must be possible to read data stored by the previous version or other methods must be available to read the old data...
Software should be retained in the archive if necessary to read or reconstruct data.
Fortunately, old software and operating systems can now be installed in virtual machines. While physical computing devices have their own operating systems, virtual machines are ‘software computers’ which can run on other host computers. Thus, using virtual machines eliminates the risk of hardware failure. Virtual machines can be accessed securely and remotely from modern devices.
MHRA and the OECD have recognized the importance role of virtualization for managing legacy software that is needed to read archived study data.
Intact Digital uses state-of-the-art virtualization and remote access technologies to enable the use of legacy software.
6.17.1 Archive
When legacy systems can no longer be supported, considerations should be given to maintaining the software for data accessibility purposes as long as reasonably practicable. This may be achieved by maintaining software in a virtual environment.
INTACT Software Library provides a platform and services for installing, validating, and hosting software installations needed for long-term readability and use of data.
We host your legacy software in Intact Digital data centers and enable its use through secure virtual desktops. That way, you have validated and carefully maintained readers of your archived data, enabling reliable reconstruction of past studies.
INTACT Software Library complements your electronic data archives and supports archivists and scientists in meeting the requirements of GxP regulatory audits.
During a study reconstruction, a copy of the data from your electronic archive is transferred securely to the INTACT Software Library environment to be used with a specified and validated software installation.
The original archived data stays unchanged and unaffected by the study reconstruction process. The used data copy is removed from the Software Library when the task is completed.
An authorized user can use a modern and secure device to login into your INTACT Software Library through a standard Internet Browser. Virtual Desktops, with pre-installed software, appear as tab windows. You can access multiple virtual machines through different browser tabs at the same time.
Data transfer is enabled through Transfer Desktop, a specially configured virtual desktop to enable secure transport of a data copy into the appropriate virtual desktop for processing. Once the task of reconstructing your study is completed, the data copy is deleted and the virtual machine is closed.
Your organization and individual research teams can have their own INTACT Software Library accounts to manage software important for long-term data use.
INTACT Software Library set-up procedure is standardized and informed by requirements for regulatory compliance. It involves
Each INTACT Software Library comes with three components and flexible service and maintenance agreements to meet your specific needs.
We offer flexible subscription plans to meet your long-term needs
Your INTACT Software Library expands over time as software technologies become obsolete
Easily add new software, enrol new users, and specify access privileges.
