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 however is growing in response to enhanced regulatory requirements, the evolving expectations of consumers and the competitive nature of the sector.
Businesses need data they can rely on and use to achieve this they must ensure the integrity of that data. This is where the ALCOA+ principles play a vital role in the successful creation and management of data.
In the second of our blogs exploring the ALCOA+ principles, we’re focusing on ‘COA’; Contemporaneity, Originality and Accuracy.
You can read Part 1 – Attributability, Legibility, here.
It’s essential that a record of an activity is made at the time it takes place and that data collection is timestamped. This is almost always achieved by default with digital data so this often poses more challenges when it comes to manual record-keeping.
Any changes or updates to the record must also be tracked. It is much easier to maintain and track changes between digital records compare with physical copies of data, at the same time there mustn’t be complacency. Audit trails must be properly maintained, detailing when the file was created, by who and who made what changes and when.
Correct metadata for each file is also essential – much of the contextual information around a document is vital to understanding its contemporaneity. Maintaining metadata is not easily done and requires diligence from those responsible for the data.
Original files should be kept on record at all times regardless of the format and where it was created. Maintenance rather than just storage is vital as both digital and physical records can degrade over time.
There has been an increase in ‘born digital data’ in recent years, as operations are increasingly digitised. Through effective digital preservation it’s easier than ever before to ensure you have kept the original file, but there is still a risk of poor practices, mistakes or complacency setting in and those files go missing. Businesses need to not only properly archive original files but implement processes to ensure that they don’t degrade and become inaccessible.
Robust version control is also a must, ensuring that all changes are documented effectively detailing when and who made them.
The information must be consistent, truthful and a fair representation of the facts it’s portraying. With the increase in born digital data, a key consideration here is ensuring that proper audit trails exist to demonstrate who has accessed what and that no changes or errors are introduced
Creating and storing metadata is vital – the more there is, the more accurate the record can be and the easier it is to find in the future. Strong metadata combined with a reliable audit trail ensures that weight is added to the accuracy of information, even if it’s being accessed many years down the line.
Many companies would have traditionally kept information on physical records and it creates challenges to maintaining ‘COA’. As the pharma industry moves forward with digital transformation efforts, many of the best practices contained with ALCOA+ will be much easier to follow through digital record keeping. As digitisation progresses, organisations need to consider how far their thinking has progressed on digital record keeping? What level of knowledge they have in these areas? What plans do they have in the future to manage their data?
There are still different levels between simple storage of digital records and proper, effective data management which includes preservation and security. There might be an assumption that many storage providers include things such as audit trails, extensive metadata and maintenance, but they often don’t.
Simply digitising and storing records is not enough to meet the principle of ALCOA+, proper governance and appropriate tools are needed, ensuring information is secure, compliant and value can be extracted from it.
In the next blog in this series, we explore ‘+’; Complete, Consistent, Enduring, Available.
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…
18 Aug, 2020
The ALCOA+ principles in practice – Part 3
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…