The pharmaceutical industry has a history of struggling with data management until the inception of the ALCOA+ framework. Its introduction has transformed the way data is recorded and managed today. In an industry where there is little tolerance for errors and quality deviations, ALCOA+ has proved to be a boon by allowing the industry to integrate its data and achieve regulatory compliance.
What is ALCOA+?
ALCOA+ is a system that ensures data integrity in the pharmaceutical manufacturing industry. It is the brainchild of Food and Drug Administration (FDA) and its main aim is to integrate data and ensure data security.
Adopting ALCOA+ is essential for compliance to FDA guidelines and GMP practices.
Principles of ALCOA
ALCOA is an acronym that stands for
The ‘+’ at the end of the word indicates the additional elements that are a part of the system, which are complete, consistent, enduring, and available.
In order to benefit from the system, it’s imperative that you have a thorough understanding of each element, which will enable you to implement the system successfully and reap its rewards.
So, let’s take a deep dive into the elements that form ALCOA+ and understand each one of them in depth.
Attributable: According to ALCOA+ principles, all the data generated must be traceable back to the person who recorded or collected it. This means that the individual recording the data is held accountable for it. In case there is an error that comes up at any point of time, we can always go back and find out who was responsible for it and take necessary action so further damage is prevented and preventive actions can be taken.
Legible: All data should be recorded in a way that it’s clearly readable and easy to understand even if it is referred to after years. If manually recorded data is converted to electronic data, both the forms need to be legible, so that you consistently build data you can rely on in the long run. Even if you want to refer to this data a decade or two after it was noted, it should be easily understood and make sense to all relevant parties.
Contemporaneous: All data, whether it be results of some studies or measurements of some sort, must be recorded as and when the activity is done. Leaving it for later increases the chances of error and compromises the integrity of the data. As per this principle, all data should mention the time and date when it is recorded, so you have the complete information when and if you need to refer to it.
Original: Even if there are several similar activities taking place in tandem, care must be taken to ensure that each data is original and not simply copied from the results of a similar activity performed at an earlier stage. In case the data is found to be copied, the person who has recorded the data needs to prove its authenticity.
Accurate: All data should be error-free and be authentic. A system to cross-check data can be put in place while recording, to minimize human error and boost accuracy. If manually recorded data is migrated to an electronic medium, thorough checks need to be carried out to ensure the accuracy.
Now, let’s see what the additional principles are:
Complete: All data should comprise relevant information that is needed for a specific type of activity. Incomplete reports should be discouraged and considered as flouting the principles.
Consistent: All data must be stored in pre-decided formats, so that a quick once-over is enough to catch all the necessary pieces of information. For example, if a certain type of report mentions the date on the top left corner of the page, other similar reports should also do the same and not deviate from it.
Enduring: The data should last for a pre-defined period, so that it can be referred to in the future if required.
Available: Data should be easily accessible any time the need arises. While it is considerably easier to achieve this in case of electronic records, special care needs to be taken to ensure physical reports are also easily available.
If you look at it, the ALCOA+ is merely applying common sense to ensure data integrity. These principles help us in sticking to the good practices when it comes to recording and managing data. If we stick to these principles with dedication, eventually they will become second nature and we will be storing accurate and reliable data without having to think about it.
Our entire solution set for the pharmaceutical industry is ALCOA+ compliant that enables you to ensure data integrity effortlessly. If you want to know more about ALCOA+ principles or our solutions, please feel free to get in touch with us at https://www.pharmision.barcodeindia.com/