> ALCOA+
What is ALCOA+?
The acronym ALCOA captures principles established by the US Food and Drug Administration (FDA) to ensure data integrityโprinciples that are essential for any operation adhering to Good Manufacturing Practices (GMP).
ALCOA stands for Attributable, Legible, Contemporaneous, Original, and Accurate. These principles were later extended to ALCOA+ to include: Complete, Consistent, Enduring, and Available.
Beyond ALCOA+, similar concepts are often grouped under the umbrella term โData Integrityโ 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 more critical than ever.
Download this white paper to understand:
- What the FDA specifically looks for in data integrity.
- How ZONTAL ensures your data is instantly compliant and available for reuse.
- How ZONTALโs FAIR Data Hub solves three key challenges in one solution.
