At Arkivum we often see a disconnect between applying the ALCOA+ principles to ‘live’ data and archived data. I’d argue that in my experience there is a common misconception that applying the ALCOA+ principles to live data, automatically means that the integrity of those records and data will be maintained in perpetuity.
In this post I’m going to challenge that view, and lay out some considerations about how to apply the ALCOA+ principles to long-term digital content.
But first, for those of you unsure what the ALCOA+ principles are…
What are the ALCOA+ principles?
The ALCOA+ principles are a set of guidelines widely used in regulated industries to ensure data integrity. ALCOA+ stands for Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available.
These principles were initially developed by the U.S. Food and Drug Administration (FDA) to ensure the reliability and authenticity of data in the pharmaceutical industry. Over time, they have been adopted and adapted by various industries that rely on accurate and trustworthy data. They are also regularly referenced by other regulatory bodies such as the EMA and the MHRA.
The ALCOA+ principles provide a framework for data management throughout its lifecycle, from creation to long-term storage and if required, it’s destruction. They emphasise the importance of data being;
- Attributable to a specific individual or system.
- Legible and easily understood.
- Captured in a contemporaneous and original manner.
- Accurate and reflecting true values.
- Complete and leaving no gaps.
- Consistent in format and presentation.
- Enduring and resistant to degradation.
- Available for retrieval when needed.
Ultimately, they provide the means by which we can trust digital content.
Applying ALCOA+ to archived data
As I stated in the intro of this article, I want to challenge the misconception that when applying ALCOA+ you should consider ‘live’ records and data the same as archived records and data. While many of the practices are the same, or at least similar, we need to look at each principle through a different lens.
Storing data and digital content for long periods of time presents different challenges to managing data which is in use day to day. Today, we’re often mislead by the common use of the term ‘archive’ in many of the applications we use on a day-to-day basis. Our email accounts can ‘archive’ emails or WhatsApp allows you to ‘archive’ conversations which you’re no longer part of. This isn’t proper data archiving. It is simply the process of moving the data somewhere that you cannot see from the main interface, but can be accessed later if required.
Successful long-term data storage requires ongoing maintenance and effort to guarantee long-term trust, access and use of that data.
In the context of ALCOA+ this means that we need to think about additional considerations for these long-term records. Let me illustrate this by looking at a principle in more detail.
ALCOA+ long-term requirements in depth – Enduring
The ALCOA+ principle enduring as described in the EMA’s guidelines for computerised systems is as follows:
Data should be maintained appropriately such that they remain intact and durable through the entire data life cycle, as appropriate, according to regulatory retention requirements.
But what does this mean in practice for long-term data? Below are just some of the considerations you need to think about when aligning your approach to the principle:
- Do you check and verify the integrity of your data and records when moving or copying that content?
- Are you regularly checking and verifying the integrity of all your stored records and data?
- Do you have a plan and a process in place to replace or repair any corrupted content as necessary?
- Do you keep at least two or three copies of the data in separate geographic locations?
- Do you have a plan in place to address obsolescence risks of storage hardware, software and media?
- Do you maintain logs of both human and computerised actions that take place on the digital content?
- Do you periodically review these logs?
Now many of the above do not apply to live data – the risk is so small that they don’t need to factor into thinking. This is not the case for records and data that needs to be kept over decades or longer, where the risks of corruption, loss, in access and obsolescence significantly increase.
…and to think, this is for just one ALCOA+ principle.
Applying ALCOA+ to archived data
Given this is a blog post, I won’t run through all the principles here, but there is a strong argument that each requires additional effort to fully align your long-term data storage approach to ALCOA+.
Successful long-term data management requires ongoing effort and maintenance to guarantee that your records and data are trustworthy, accessible and usable for however long you need to keep them for.
If you’re interested in reading more about maintaining the integrity of your long-term records (and considerations for the other principles) we published an eBook covering this. You can have a read of it here.
Finally, we also recently launched a lightweight assessment tool in this area, to help you assess your current approach to long-term data management and how it aligns to ALCOA+. All it entails is a short quiz and you receive your results, with recommendations, immediately – you can access that here.
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