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Manufacturers are always looking for new ways to leverage technology to extract, process, and visualize data to gain insights for their businesses. These insights help to inform business decisions, allowing manufacturers to get the most out of their operations by maximizing efficiency and productivity.
Additionally, clear, accurate production data has become critical for demonstrating compliance during audits by regulatory bodies—particularly in industries like pharmaceutical and medical device manufacturing.
In order to ensure the integrity of the data being collected, regulators and governing bodies have put in place a number of guidelines for manufacturers to follow. In particular, the US Food and Drug Administration (FDA) has provided outlined a set of principles known as ALCOA to help guide practices surrounding data collection and integrity within the life sciences industry.
In this post, we’ll explore the ALCOA principles, their meaning, and how life sciences manufacturers can apply them to their operations.
What is ALCOA?
ALCOA is a set of guiding principles outlined by the FDA that helps govern data integrity in the manufacturing industry. It was established in 2018 as guidance for manufacturers responsible for data integrity as outlined by 21 CFR Part 11.
In particular, regulated manufacturers like those in the life sciences industry use these principles in their operations to demonstrate that their product was made safely following the validated processes outlined by the manufacturer.
The term ALCOA is an acronym entailing the various principles as defined by the FDA. It stands for Attributable, Legible, Contemporaneous, Original, and Accurate.
By embracing these principles across a company’s data management system, businesses can ensure that the data they’re collecting is accurate and that outlined processes are being correctly followed.
As the manufacturing landscape has evolved to adapt to changes in processes and technologies, regulatory bodies have expanded the ALCOA principles to further support life science manufacturers through good documentation practices. Consequently, the accepted set of principles now includes Complete, Consistent, Enduring, and Available. Together, these good documentation principles are referred to as ALCOA+.
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What are the 9 principles of ALCOA?
Now that we’ve outlined the basics of ALCOA, let’s dive into the specifics of each principle:
1. Attributable: This principle requires life sciences manufacturers to identify and record the entity responsible for acquiring or using a given data point. Additionally, manufacturers should state the date and time of data collection.
These identifying features provide more information about the data, allowing manufacturers or compliance auditors to have a more representative picture of a particular data set.
2. Legible: In less advanced manufacturing operations, businesses rely more heavily on paper-based records. Unfortunately, such records are more susceptible to human error, making the data more difficult to read.
Modern operations use digital data extraction and recording mechanisms, reducing error and making the data more legible.
3. Contemporaneous: When harvesting data, manufacturers must ensure they record the precise time of collection. Additionally, the records should also show the time of any subsequent document modifications.
4. Original: Manufacturers should always use the original data in their master record. Further data processing requires the initial primary data instead of copies or secondary sources.
5. Accurate: Good documentation practices require manufacturers to input correct and unedited data. Otherwise, data analysis returns unrepresentative information that tarnishes the resultant business decisions.
6. Complete: Life sciences manufacturers should keep all data generated. Even when the original data points aren’t in use, there should be a complete audit trail that features the data modifications and the time any such edits were made.
7. Consistent: Related to the completeness, data records should also be consistent. In other words, data should be the same when accessed from anywhere within your system.
Furthermore, one should be able to follow any modifications sequentially to get a consistent picture.
8. Enduring: Records and information should be stored long after the data collection. In life sciences, this vital data might be referred to down the road – years or decades. Businesses usually make use of local and cloud-based backups to keep data for long periods.
9. Available: While it pays to store data for long, it’s even more important to retrieve that long-stored data whenever needed. Therefore, good documentation practices should involve making data available whenever authorized entities require access.
The importance of data integrity in life sciences manufacturing
As earlier mentioned, manufacturers in the life sciences industry face a significant amount of scrutiny when it comes to the products they create due to the potential impact on the wellbeing of the end consumer.
Given the regular oversight and frequent audits by regulatory bodies like the FDA, it’s imperative that manufacturers account for ALCOA+ principles in order to achieve and maintain GMP compliance.
In addition to the compliance aspect of data integrity, manufacturers rely on production data to help guide their business decisions. If the data is inaccurate, inaccessible, or difficult to read and interpret, it becomes nearly impossible to drive continuous improvement or make sound business decisions.
Ultimately, manufacturers rely on clear, accurate data not only to ensure the safety and traceability of processes and products, but also to help identify points of inefficiency across their operations to enable supervisors to issue corrective actions.
Streamlining data collection with manufacturing software
As we’ve outlined, ensuring data integrity by following ALCOA+ principles has become table stakes for manufacturers in the life sciences industry. However, this can become needlessly difficult for manufacturers that are still leveraging paper records in their operations.
Such approaches result in more errors, rendering the data unusable. Additionally, manual collection methods might skip over some vital and supportive data points, providing manufacturers with incomplete or non-actionable insights.
For example, we’ve worked with many manufacturers that have historically documented their batch records or history records using pen and paper, and as a result, have run into issues with inaccurate or illegible data entry. This creates a massive headache when it comes to regulatory audits.
To avoid these issues, manufacturers have turned to solutions like Tulip to help automate data collection, enabling businesses to digitize their production records and eliminate human error from their compliance procedures.
Using our Digital History Record app, manufacturers are able to account for every ingredient, activity, and person involved throughout a given production process, creating a digital audit trail that ensures all ALCOA+ principles are accounted for.
If you’re interested in learning more about how Tulip can help you simplify and automate your production records, reach out to a member of our team today!
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