The acronym ALCOA captures principles laid down by the US Food and Drug Administration (FDA) about data integrity that are essential for any operation that needs to adhere to Good Manufacturing Practices (GMP).
ALCOA stands for Attributable, Legible, Contemporaneous, Original, and Accurate. The principles have since been extended with ALCOA+ to include the following: Complete, Consistent, Enduring, and Available.
Outside of ALCOA+, similar concepts are often summarized under the umbrella term “Data Integrity” and are in part repeated and extended in the FAIR (Findable Accessible Interoperable Reusable) data principles.
Regulators around the world are increasingly issuing citations for violations of data control principles, making compliance critical.
|Specifically what the FDA is looking for|
|How ZONTAL ensures your data is instantly compliant and available for re-use|
|How ZONTAL’s FAIR Data Hub system solves three problems in one|