Applying ALCOA+ for +25 Years
Maintaining data integrity and ALCOA+ for decades
The ALCOA+ (or ALCOA++) principles have now been almost universally adopted by regulators around the world, as the set of principles organisations must adhere to in order to maintain data integrity. Created by the FDA, they are referenced within regulatory publications such as the EU Guidelines on Computerised Systems and ICH E6 (R3). You can even see the language of the principles used explicitly within regulations such as EU CTR.
A common misconception we often encounter at Arkivum, is that if an organisation is applying ALCOA+ to live data (as in data recently generated or in use day to day), then ALCOA+ will be maintained throughout the entire retention period.
This could not be further from the truth.
Let’s take the principle ‘Legible’ as an example. Ensuring documents and data created this year are legible is fairly easy. Any device with the right software should be able to recognise, open and read the majority of common formats in use today.
But what about 20 years from now?
The devices, hardware and software we’ll be using in 2050 will be very different from what it is today. I would argue it’s highly unlikely, whatever the device is, that it would be hard pushed to open a word document or email thread created in 2026.
Ensuring legibility therefore becomes a lot more challenging. How do I guarantee that my digital content will be legible for decades into the future?
And this is just taking into consideration a single ALCOA+ principle.
Throughout this guide we will be highlighting various considerations and approaches you will need to overcome, in order to ensure alignment to the ALCOA+ principles. Where applicable, we’ll connect the concepts that we’re introducing to the ALCOA+ principles within the context of long-term data management.