When implementing an Information Governance strategy, organisations often overlook the need to include a digital archiving solution, for retention and preservation of data into the long term.
What is Digital Archiving and Preservation?
Whatever industry you’re in, information governance is important to ensure good information practices, mitigate financial penalties and maintain reputation. That should therefore include data archiving and preservation policies that last longer than the immediate-term, which is where many InfoGov strategies stop.
Why is digital data archiving and preservation relevant for Information governance?
Information Governance is an ongoing process that should involve regular reviews, audits and improvements in how an organisation handles information, including after the data has been archived and is no longer actively used.
Organisations need to standardise policies across the business and improve the ways that information is accessed and used. The complicated tasks involved in managing your data for information governance purposes is exacerbated further when you consider in the vital requirement to manage this information over the very long term.
When considering a data archiving and long-term data management strategy you need to ensure that you are able to answer the following questions in relation to your data if asked:
- What is this information? You need to ensure that you can provide context to the data 10 / 20 / 30 years down the line or for as long as the data is needed.
- When was this information created or processed? It is vitally important to be able to mandate how long the data should be held for.
- Where is my data? You need to know what data is where and how to access should you be required to provide evidence of compliance or respond to a subject access request. It is not good enough to store the data on hard drives in a box marked “archive”.
- Who has access to this information? User permissioned access is essential when you are handling personally identifiable information, even when this is in archive.
- Why is this information being retained? Retention policies and management of potentially conflicting regulations such as GDPR’s “right to be forgotten” and the need to keep data for research purposes.
In order to answer these questions, you need to ensure that you are able to associate your files with relevant metadata in an easily accessible and searchable format.
Bring your dark data out of the shadows
When it comes to archiving digital data, organisations often put in place a form of backup, whether that is online or offline, this causes a major headache when it comes to information governance. The consequence of this is the creation of dark data – data which has no context when revisited.
Dark data is a major problem for many organisations, not least when trying to manage information governance. In order to shed light on the situation you need to include digital archiving in your information governance strategy from the start to ensure that you do not get into a situation where you are unable to prove compliance with certain data sets.
Chaotic data management makes you a target
Although information governance standards are not always mandated by regulations (excepting regulations such as GDPR), it is still important to treat the information that you hold as if it was. Not least that if you were shown to be falling short of information governance standards you could be open to reputational damage.
It can be beneficial to look at how highly regulated industries manage their data when considering information governance requirements for archived data. With regulations such as the MHRA Data Integrity Guidelines and FDA 21CFR11 in the life sciences industry and MFID II in the financial services industry, these data rich industries are under strict scrutiny in regard to their data.
There are a number of similarities between information governance requirements and Data Integrity guidelines within the life sciences sector, especially in regard to future accessibility of information in your care.
Metadata management, long-term archiving and digital preservation within your Information Governance strategy is extremely important to ensure that you are able to comply with all information governance requirements for the life of the data. Without it you can put yourself at risk of exposure in terms of financial, legal and reputational impact.
You also need to consider the implications of:
- Changing file formats – can you actually access the data years down the line?
- Can you easily search for data you need, either for access requests, legal requirements or future re-use?
Download our Information Governance fact sheet to find out more about what to consider in terms of information governance when moving from live data to archived data.
23 Jul, 2019
Arkivum demonstrates alignment with regulated Life Sciences data management requirements including GxP regulations, award of ISO 9001 and ISO 27001 certifications and successful customer and partner audits
Arkivum, the leading provider of long-term data management and digital preservation solutions, today announced it has achieved pharma-level compliance with the award of ISO 9001:2015 certification, demonstrating…
19 Aug, 2019
Compliance is a necessity that can achieve the greater good in your GxP data
Working in such a highly competitive market, it is becoming increasingly difficult to stand out from the competition. Complex data requirements make it difficult to provide competitive…
16 Jul, 2019
A Fortune 500 Life Sciences enterprise chooses Arkivum to provide long term management of its GxP regulated research data
A Fortune 500 Life Sciences enterprise chooses Arkivum to provide long term management of its regulated research data generated by its FDA Class III medical devices. Arkivum…