Preserving data from retired systems
Organisations within the life sciences sector are fast becoming big data enterprises; the need to innovate on modern drug discovery and research methods, including data collection is growing exponentially. While the advantages of utilising enhanced data collection methods increases, the strategic importance of preserving data from these systems as they near the end of their lifecycle is often overlooked. Organisations in this situation will often employ tactical solutions to deal with the issue which can impact on long term data integrity and accessibility.
As part of a product’s lifecycle a medical device manufacturer plans an end of life where the product and/or application is decommissioned and no longer supported. This often leads to the system being disconnected from the network to minimise security risks. This in turn leads to difficulty in managing the data and concerns over the compliance of data retention. The limited connectivity creates silos of data making it difficult to report on or access it for audit or further research purposes.
Organisations face a frustrating issue in this case when the data is in a proprietary format and can be viewed only by the application software that comes with the instrument as the software runs on an old unsupported operating system and old unsupported hardware.
Many organisations in this situation are concerned about turning on the original device and associated applications for fear of the device breaking irreparably, losing valuable data forever. There is often not a strategy in place for preserving data from retired systems.
In order to ensure you comply with MHRA data integrity guidelines and GxP principles whilst still making the data usable, you need to break down data silos and create a single view of your data, all whilst keeping the data complete, consistent, accurate and in its original form.
The MHRA, FDA and WHO all support the use of the ALCOA+ principle to measure compliance of the data integrity guidelines. If you comply with ALCOA, you will be able to ensure that you preserve the data integrity and the long-term readability of your data and therefore withstand regulatory scrutiny.
Currently employed solutions
There are a number of solutions that organisations employ when preserving data from retired system Each has its own problems.
1. Paper copies
Many organisations will simply print the original data and store the paper copy.
Data Integrity guidelines from the MHRA are very explicit in relation to paper copies – they state that if the original data was created in a digital format, that it should also be preserved in that format.
2. Export to a common file format
Some organisations may export data to a common format such as a PDF.
When exporting to different formats than the file was originally created, there is a real possibility that you will lose the original metadata associated with that piece of data, thus not complying to the “Original” section of ALCOA.
3. Storing data on physical disc and putting away (Creating an archive folder)
Organisations may save the data on a hard drive and put them in a box in storage or create an archive folder on a shared drive.
This often does not comply to GxP principles and is not best practice to archive electronic records in life sciences. Accessibility of the data can be an issue, from not knowing which disc (or folder) the data is saved on, to file formats not being readable at the time of access.
4. Data Backup
Many IT departments will employ backups such as cold storage.
Backups are not intended for the long-term preservation of scientific data. The same issue arises where file formats may not be readable at time of access, as well as the risk of data corruption. If data is corrupt you will need to retrieve a previously uncorrupted version of the data, but you may not have a backup with uncorrupted data.
Creating virtual images of applications to access the data can be used in the short term to refer to the data.
A reasonable approach to making sure that you are preserving application software for data in proprietary formats, however there are considerations that you need to be aware of. Data integrity needs to be actively managed; corruption can still happen and updates to virtual machine images still need to be applied.
6. SDMS (Scientific Data Management System)
Most organisations have a Scientific Data Management System (SDMS) which manages their data.
While an SDMS provides audit trails for ALCOA+ compliance and some data normalisation into an XML format, they are generally designed to support specific systems and do not often have file converters, meaning that the original application software would still be needed to access data. Read more on why Scientific Data Management System (SDMS systems) aren’t enough to manage data from decommissioned systems
The Thermo Fisher 7900 and Arkivum example
In order to comply with regulations you need to actively manage data, keep it in its original form and ensure accessibility to anyone who needs it.
In our recent webinar with guest speaker, Dr Jonathan Mangion, Head of Bioinformatics, EMEA at Thermo Fisher, we explore a very real example where Thermo Fisher has announced that the 7900HT instrument is to be decommissioned. We describe how in partnership, Arkivum and Thermo Fisher can help with consolidating your legacy data in order to comply with GxP principles.
Whilst this example is specific to the Thermo Fisher 7900 use case, the principle is the same for any other decommissioned systems and applications and the solution is still applicable. If you have a specific decommissioned system or system approaching end of life and would like to discuss your requirements, please contact us.
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