Manufacturers need to demonstrate that their products are made safely and establish trust in the data submitted to regulatory authorities.
With the increasing globalization of the life sciences sector, the use of contract manufacturers, strict compliance with CFR 21 Part 11, and rising auditing demands, the importance of data integrity continues to grow—not only in the context of new drug, biologic, and medical device approvals but throughout the entire product lifecycle.
The FDA's Integrity ALCOA principles were first introduced in the 1990s and aim to ensure the quality and integrity in processes of the pharmaceutical industry and are vital for maintaining data integrity and ensuring compliance with regulatory standards.
The acronym ALCOA stands for:
Attributable: Data should be traceable to the individual who generated it, ensuring accountability.
Legible: Data must be clear and easily readable to prevent misinterpretation.
Contemporaneous: Data should be recorded at the time the activity is performed, ensuring that it reflects real-time events.
Original: Original records or certified copies should be used, maintaining authenticity.
Accurate: Data must be correct and free of errors, reflecting true information.
The ALCOA principles are vital for maintaining data integrity and ensuring compliance with regulatory standards. They help to establish trust in the data submitted to regulatory authorities, such as the FDA, particularly in the context of the approval of new drugs, biologics, and medical devices.
In recent years, the concept has been expanded to ALCOA+ (with Complete, Consistent, Accessible and Enduring added), emphasizing the need for data to be complete and consistent while being easily accessible and maintained over time.
Pion’s DissoPro software, used in conjunction with our Rainbow Dynamic Dissolution Monitoring System for QC dissolution testing, contains the features that are required in the QC lab and are commonly used in GMP and 21 CFR Part 11 compliant environments. These tools include secure records, electronic signatures, audit trail, and user security.
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