The marriage between manufacturing and technology continues to help support streamlined processes that enable the best of both worlds. That is, a smooth and healthy bottom-line operational process while at the same time producing items of the highest quality possible for the end consumer. This is especially vital when it comes to those manufacturers that primarily deal with life sciences products, and it can be quite harmful to humans if the appropriate actions aren’t taken.
This all starts with the data integrity behind the manufacturing process, and an excellent way to ensure one is able to follow the best path to data integrity is to consider the integration of the Alcoa Principle. This principle also helps bring forth data integrity, which is the combined practice of accurate data and consistency with that data through the entire process.
What is Alcoa?
To get deeper into what ALCOA is all about, the ALCOA principle is a set of guidelines that come directly from the Food and Drug Administration that has its complete focus on data integrity and governance around it. This ALCOA data integrity is fully focused on the manufacturing industry and is still a recent principle that was only established back in 2018 (Drafted in 2016) in reference to FDA guideline 21CFR Part 11.
This is so important, especially to those in the life sciences manufacturing industry, because the Alcoa principle helps to produce safe products that are consistently validated and are a method of best practices. Those that are regulated must follow ALCOA data integrity practices, and they should anyway because the data and consistency help to produce products faster as well, which can help improve margins. So it’s not just about a compliance matter but also a matter of efficiency.
ALCOA itself is actually an acronym of what the core principles are to follow that the FDA requires for anyone dealing with this type of manufacturing. It stands for Attributable, Legible, Contemporaneous, Original, and Accurate. We’ll go into a much deeper look at each one below.
ALCOA data integrity is about the mix of the manufacturing process with a strong data management system. The better developed the data management system, the easier it is for the business to collect the data points to confirm their accuracy and to conform to the ALCOA principle in general.
The ALCOA principle is constantly evolving, even after only being born four years ago. This is because of the rapid shift and changes in technologies and the Internet of Things, allowing for a more complex standard to evolve from the original requirements of ALCOA Data Integrity. That’s why there’s already been an update to the measure known as ALCOA+, which includes an additional four principles.
The 9 principles of Alcoa
- Attributable: Here, it’s about being able to identify the recordkeeper. Whether it’s a person, a system, or even some type of device that automatically generates information, that source of the data needs to be easily recorded. Then it needs to be time-stamped with the date so that it’s possible to track this point.
- Legible: In the past, this was more about being able to read paper-based records before the influx of data management systems. Now ALCOA data integrity is all about conformity of the information itself in a standard way to read the data.
- Contemporaneous: Another point that’s easily solved with the right type of system when collecting information is the exact time and date that needs to be recorded at the point of collection. If there are modifications, later on, that also needs to be tracked.
- Original: Whether manual or digital, there should always be a system in place to keep the original record and to verify that it is not a copy. Even if the analysis is done later on, it should be able to track and reference the original data.
- Accurate: The data points collected need to be clear and representative of the information it’s gathering. The data itself should come in unedited or modified either.
What is Alcoa+ ?
The plus (+) portion of ALCOA consists of additional characteristics of good data, including the following:
- Complete: This relates to manufacturers practicing ALCOA data integrity to hold on to their always-generated data. Even if the data doesn’t apply any longer, a full audit trail should always be available. This is also inclusive of retesting data and analysis of the data, as well as any updates or edits.
- Consistent: Thorough data should be easy to access and easier to file. That means whatever record-keeping method is used should be universally applied, inclusive of updated information.
- Enduring: Be prepared to store these data sets and records indefinitely. Think decades of storage for these data points, and it’s best to utilize cloud-based systems to minimize costs and maximize storage and security.
- Available: Make sure that all data sets, archived or recently added, are easy to access at any point and time. With the above principles applied, this one should be the simplest to achieve, especially when third parties would need access to it.
Alcoa vs. Alcoa+ principles
Many may wonder if there’s a choice between just the traditional ALCOA principle and ALCOA+ Principle. The ALCOA+ is a more well-rounded approach to data integrity that makes plenty of sense that those looking to ensure property data integrity should include in their data management system. This means including the last four components of ALCOA principles which are having complete, consistent, enduring, and available data and information.
The importance of data integrity in life sciences manufacturing
Without integrating a proper overall data integrity system, the veracity of the information comes into question. It leads to an unorganized, unverifiable, and incomplete set of data that’s sporadic and doesn’t lay down a consistent story. That means not switching to a system that has electronic batch records, or follows Current Good Manufacturing Practices or cGMP regulations, can lead to poor data integrity. You can see further how important cGMP is [4]. In the case, something goes wrong, and there’s no simple way to assess what the root cause analysis was, it could lead to a plethora of issues for the manufacturing company.
It could lead to costly and time-consuming inspections that increase in frequency. This can also lead to suspensions of product manufacturing, all due to a lack of data integrity management. This, in turn, compounds into violations, bans, and, ultimately, criminal enforcement. There’s also been a recent increase in data manipulation – specifically in Asia in recent years [5].
Without taking a more proactive approach to data integrity by implementing a system such as the ALCOA Principle, there is the possibility of running into the issues above. In addition, it will also affect the image of the manufacturer and cause a loss of trust from the public, which at times can be irreparable. Not to mention a huge loss to have critical data points that can support tactical and strategic decision-making, all because of a lack of proper record management and data integrity.
Ensuring data collection with manufacturing software
Whether you’re manufacturing pharmaceutical products or medical devices, having the right type of manufacturing software will help to adhere to ALCOA+ principles. That’s where Azumuta comes into play and helps to digitize your shop floor operations completely. It’s about getting rid of manual or paper-based tracking of all aspects, as well as loose digital files that always seem to get lost.
All this information can be collected and updated in real-time, adhering to ALCOA principles. In addition, Azumata itself has its own pillars to ensure a Paperless Factory, proper Data and Analytics, and seamless connectivity through IoT.
Whenever you’re ready to achieve ALCOA principles and smoother operations, Try now!
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