ALCOA+ is a framework or set of principles that ensures data integrity. It was introduced by, and is still used by, the FDA – the US Food and Drug Administration. It has relevance in a range of areas particularly in relation to pharmaceutical research, manufacturing, testing, and the supply chain.
As well as being essential for compliance reasons, the ALCOA+ principles are becoming increasingly important to GMP (Good Manufacturing Practices).
The Importance of Data Integrity
Data has always been important in pharmaceutical manufacturing and research. A range of different factors, however, means the importance of data is growing exponentially. The drivers for this include enhanced regulatory requirements in addition to the evolving expectations of consumers and end users as well as the increasingly competitive nature of the pharmaceutical industry.
You can’t just have data, though. Instead, you need to have data and you need to ensure the integrity of that data. When you have this, you have data you can use and rely on.
The ALCOA principles ensure data integrity. They apply to the following types of GMP records:
- Electronically recorded – data recorded using equipment that ranges from simple machines through to complex and highly configurable computerised systems
- Paper-based – a manual recording on paper of a manual observation or of an activity
- Hybrid – where both paper-based and electronic records constitute the original record
- Others – this includes photography, images, chromatography plates, and more
The ALCOA Principles
ALCOA is an acronym for the original five principles of data integrity. Those principles are:
However, the original ALCOA principles have since been updated to ALCOA+. The original principles remain with four additions:
Let’s look at each of the principles in more detail.
When creating a record, you must record the identity of the person or computer system that collected or generated the data. It’s also important to record the date of the collection or generation.
Ensuring data is legible is about more than being able to clearly read the data, although that is important in situations where manual data record-keeping takes place. Being able to make out the words is much less of a problem with electronic data, though.
That said, ensuring data is legible still has relevance. This is because it must be possible for data to be read and understood years and even decades after it’s recorded. This can have as much relevance to digitally recorded data as it does to data recorded in notebooks.
In other words, it’s important to avoid using clichés and unusual phraseology as this may be difficult to decipher in the future without getting clarification from the originator of the data, a person who may no longer be available.
Using consistent, straightforward language throughout an entire organisation, regardless of locality, is the best approach.
It’s essential that individuals or systems make a record of an activity at the time it takes place. With electronic data, this is normal practice, so this is another point that has more relevance to manual record-keeping.
Records should be original rather than copies or transcriptions. Again, this applies mostly to manual record-keeping. For example, you should not write a record on a scrap of paper with the intention of completing the main record later, as this can result in errors.
Instead, the original recording of the data should be on the main record, whether that record is on paper or on a digital system.
All records should reflect the reality of what happened and should be error free. Also, there should be no editing of the original information that results in that information being lost.
If changes are necessary, those changes must be documented in a way that makes it possible to refer back to the original information. Nothing should be removed, blocked out, or deleted.
When recording data electronically, the system must have built-in accuracy checks and verification controls.
All recorded data requires an audit trail to show nothing has been deleted or lost.
This primarily means ensuring data is chronological, i.e. has a date and time stamp that is in the expected sequence.
While this is touched on in a previous principle, this principle of ALCOA+ places specific emphasis on ensuring data is available long after it is recorded – decades in some situations.
This point follows on from the last point, i.e. data must not only exist, it must be accessible. The most efficient way of achieving this is normally by recording data electronically.
Data Integrity and Validation
Data integrity is essential to all validation processes in pharmaceutical and medical device manufacturing facilities. Following the ALCOA+ principles is the best way to achieve this goal.