ALCOA+ is a set of principles for ensuring data integrity. Introduced in the 90s by the US Food and Drug Administration (FDA), the ALCOA acronym was developed as a guide outlining their expectations regarding data and evidence (including paper-based, electronic, and hybrid).
The principles have held up incredibly well since their inception and they’ve remained relevant thanks in part to the addition of the “+” element.
The ALCOA+ principles generally apply across the board for good data management and their application has evolved across a range of areas particularly in relation to pharmaceutical research, manufacturing, testing, and the supply chain. We see many of the ALCOA+ principles utilized in GxP guidelines and they are often referenced alongside the FDA’s 21 CFR Part 11 and the EMA’s eTMF regulations.
In a series of 3 blogs, we will take a look at ALCOA+, exploring each of the principles, what they mean and how they can affect operations in the Life Sciences.
In part 1, we’re focusing on ‘AL’; Attributability and Legibility.
In its purest form, data attributability is not really about controlling access and authorisation, it’s about treating records (especially digital records) as ‘live’. This includes ensuring information such as who created the file (and when), and then comprehensively tracking changes, all while ensuring that original information is never lost.
Making data attributable is about transparency around data and not simply making individuals responsible for it. Forward thinking organisations today aspire to be transparent and that is why attributability is important – it’s not just a practical consideration but often aligns with organisational cultural values. The challenge here is having the confidence to make this move and attributable data can be a good starting point.
For businesses to properly implement good practices around attributability there needs to be a common approach to how the information is captured, what information is captured and how it is stored. It’s essential these align with any regulatory requirements and you consider what tools the business has and what is possible with current resources.
Governance documentation is always a good idea (for the ALCOA+ principles generally, not just here) and there is a requirement to ensure that someone within your organisation is responsible for the process.
For recorded data to be legible it must be readable throughout its lifecycle. At first glance, this is fairly straightforward when it comes to creating data. The challenge is the long-term preservation of data – over time formats change and data can become corrupted. Further consideration is then required on how data was born and whether it has been digitised.
Content that is ‘born digital’ is usually the simpler to store and preserve, but preservation is still key in order to maintain legibility as file formats, types and standards constantly evolve. Leaving a file dormant for years may render it illegible.
The bigger risk is associated with data created physically (paper-based). These are either stored as they are or digitised by being simply scanned and backed up either in the cloud or an on-premise solution. When it comes to legibility, physical documents simply don’t allow for proper digital preservation and the files could degrade, be lost or damaged by circumstances outside the control of the owner.
To ensure long term legibility requires an understanding of the fundamental difference between data storage/backup and preservation. Storage is just as it says on the tin – havng the data exist somewhere. Whereas, preservation is the process of actively managing that data and associated metadata in such a way that they are guaranteed to be accessible, usable and searchable in the future.
There is both an element of having the right processes in place to make this possible, as well as the technology in order to support those processes. Many of the processes involved in digital preservation can be laborious for humans, but easily automated by technology.
This isn’t a ‘nice to have’ either, the regulatory framework around eTMFs for example requires investigators to archive data for at least 25 years after the end of a clinical trial. Auditors can and will want to access this data.
To ensure legibility long-term, common file formats and processes for managing data must be established taking into consideration any organisational needs and regulatory requirements (e.g. how long does it need to be stored for).
With careful planning, proper governance, the right tools and a proactive approach, the attributability and legibility of data can be assured over the long-term in line with ALCOA+ principles.
In the next blog in this series, we explore ‘COA’; Contemporaneous, Original and Accurate.