Maintaining accurate manufacturing data is critical to improving plant performance and demonstrating regulatory compliance. In the United States, the Food and Drug Administration (FDA) requires organizations in the life sciences to follow the ALCOA guidelines, a set of principles for data collection and storage.
Learn what the ALCOA and ALCOA+ principles are and why they matter. We’ll explain how best to follow ALCOA+, so your organization achieves and maintains compliance while making the best possible use of its data.
What Is ALCOA, and What Is ALCOA+?
ALCOA is a set of guidelines first developed by the FDA in the 1990s. The guidelines are regularly updated; the full set of guidelines, including updates, is known as ALCOA+. The purpose of ALCOA+ is to ensure data integrity so that all records are accurate, reliable, and verifiable.
ALCOA stands for Attributable, Legible, Contemporaneous, Original, and Accurate. Those five principles make up the FDA’s core guidelines for data integrity. In the 2010s, the FDA added four additional principles for data collection and storage: Complete, Consistent, Enduring, and Available. The ALCOA+ principles are set out in Title 21 of the Code of Federal Regulations, or 21 CFR.
Who Is Required To Comply With ALCOA+?
Pharmaceutical manufacturers and other organizations subject to FDA oversight are required to follow ALCOA+ guidelines to stay compliant with Good Manufacturing Practices (GMP). That includes medical device manufacturers, food and beverage producers, and organizations involved in packaging either food and beverages, drugs, or medical equipment.
While ALCOA+ is intended chiefly for heavily regulated industries, its principles are valuable to any organization that relies on data to optimize productivity and reliability.
Why Is ALCOA+ Important for Organizations in Life Sciences?
For organizations that adhere to Good Manufacturing Practices (GMP) or Good Laboratory Practices (GLP), ALCOA+ is a key element of regulatory compliance. Following the ALCOA+ principles can help your organization avoid penalties and pass audits.
Even beyond compliance, ALCOA+ principles are valuable to almost any organization. Modern manufacturing depends on data to drive efficiency, reliability, and safety. Following the ALCOA+ data integrity standards ensures that you always have high-quality data at your fingertips, so you can track plant performance, set benchmarks, and identify areas of improvement.
What Are the Nine ALCOA+ Principles of Data Integrity?
There are nine key ALCOA+ standards. Here’s how to put them into practice.
1. Attributable
All your plant data must be attributable to a specific source and collection time. In practice, this means that your records must include the data collection methodology: was it a technician using hand-held tools, or a cloud-connected sensor? Your records should also include the collection date.
2. Legible
Electronic records should be stored in a safe, accessible repository, which makes it easy to surface data when needed. Of course, if you’re still using paper and pen, your handwritten records should be neat and legible.
3. Contemporaneous
Record data as soon as you capture it; never backdate it. This greatly reduces the risk of human error. A good CMMS automates this process, capturing and storing data in real-time.
4. Original
Your original records (not copies) should be stored and made available for review by FDA inspectors upon request.
5. Accurate
To ensure accuracy, every tool used to collect data should be regularly reviewed. This means instruments should be regularly calibrated and maintained; it also means that software used for record keeping should be validated (and revalidated) as needed.
6. Complete
Every piece of data should be accompanied by an audit trail, verifying that the data set is complete. If your technicians retested or reprocessed the data, that should be included in the record.
7. Consistent
Data should be recorded in chronological order, with clear date and time stamps, so it accurately reflects the timeline of events at your facility.
8. Enduring
FDA regulations stress that data should be preserved for as long as possible to provide a long-term picture of events. CMMS software is a great way to safely and reliably store data. It also makes data easily accessible for your whole team.
9. Available
Your data should be readily available so that inspectors can examine it as needed. CMMS software provides a searchable database, so you can always access your records at a moment’s notice.
Using CMMS To Maintain ALCOA+ Standards
Following ALCOA+ regulations can be overwhelming, especially if you’re still relying on spreadsheets or paper systems. With a good CMMS, the process is much easier.
CMMS software automates data collection workflows. This minimizes human error, so you don’t need to keep checking for misentered or missing data. A good CMMS will also automatically timestamp data entries, so you have built-in audit trails.
eMaint CMMS offers audit dashboards and a robust reporting function so that you can access your data at any time. Whether you’re facing an inspection or you simply want to improve a maintenance process, eMaint analytic features can help. The result is easier compliance and greater efficiency throughout the production cycle.