In the third and final part of our blog series exploring the ALCOA+ principles, we’re focusing on ‘+’; Completeness, Consistency, Enduring and Availability.
You can read Part 1 (Attributability, Legibility) here and part 2 (Contemporaneity, Originality and Accuracy) here.
The ALCOA principles have stood the test of time despite the significantly increased reliance on digital data since their inception in the early 90s’. They remain the cornerstone of good practice thanks in part to the addition of the “+” element in 2010. Building on the existing guidance, the + principles support a more rounded approach from organisations looking to improve data integrity.
Completeness refers to just that, ensuring the data is complete. This means creating and maintaining a reliable audit trail, recording metadata and documenting changes to ensure original information is maintained – this is especially pertinent in the life sciences sector during regulatory inspections.
It is important to remember that incomplete data does not tell a full story and can be misleading or at least misunderstood during downstream development or by auditors. It is vital that associated metadata and the audit trail is comprehensively recorded to ensure that drug developers have the context of the information to hand when it is viewed, potentially years down the line.
Building on the ‘Contemporaneity’ principle, consistency is about implementing robust processes that ensure data is recorded, time-stamped and can be presented sequentially. Full data integrity relies on evidence of chronology, and that all data be timestamped.
Consistency can be a real challenge, especially when we consider the length of time that information needs to be stored for – 25+ years in some instances – and how long the drug development process can be. Personnel and processes can and will change, as will technology and even organisations in the event of mergers and acquisitions. Consistency though must be maintained with regular auditing to ensure these best practices are adhered to and new people approaching the data years down the line can find and access what they need, when they need it.
A number of processes that ensure consistency can be automated when it comes to digital data and using approved data acquisition and analysis methods as well as mandatory reporting templates will improve consistency.
The endurance of data relates to its being maintained and complete for the duration of its lifecycle – a timeframe usually determined by the retention periods stipulated by regulators. A key use case here is the EMA guidelines which came into effect in June 2019 and provide regulatory framework around eTMFs requiring investigators to archive data for at least 25 years after the end of a clinical trial. However, this doesn’t simply mean storing data – to ensure data integrity, it must be actively managed and preserved through its lifecycle.
Not only does the information require regular auditing, but it must be factored in that retention periods may change – new regulations may be introduced that require a longer retention period). Other challenges can include having to pause retention periods if there is some sort of legal challenge or dispute.
Not only must data endure throughout its retention period, it must remain accessible at all times throughout. This includes ensuring that the data still exists, that it can be found and that it is still usable.
The focus area here is on how and where data is stored. File formats evolve over time and so can become obsolete, original files need fixity checks to make sure that their content remains unchanged when transitioning to new formats and that they haven’t become corrupted. It’s also vital to ensure that all systems that archived data are integrated with are accessible.
Digital preservation and electronic archiving should be considered as a process of continual improvement with organisations aiming to ensure that the measures used remain appropriate and proportionate for the digital content being held and its purpose.
It is important for archives to be able to assess their current capabilities, establish what needs to be done to meet the archive’s objectives and measure and record progress. Assessment frameworks and maturity models have been developed that help substantially in these areas and these alongside the best practice ALCOA+ principles are a good way for an organisation to understand their current maturity and then build from there.
Businesses across the life sciences that need to retain data for compliance often have to adhere to strict and demanding regulatory requirements. The ALCOA+ principles are the foundations that organisations build on to ensure such compliance, with proper data archival and preservation practices key to any successful implementation.
21 May, 2020
The ALCOA+ principles in practice – Part 1
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…
07 Jul, 2020
The ALCOA+ principles in practice – Part 2
The pharmaceutical industry is data-driven – risks are carefully calculated and managed using data, key strategic and management decisions heavily rely on data. The importance of data…