21 CFR Part 11 might really be called the Data Integrity Act. Here is a high-level look at what is needed to ensure compliance.
By John Avellanet, Cerulean Associates, LLC
Data integrity is critical to regulatory compliance, and the fundamental reason for 21 CFR Part 11. This article outlines and summarizes strategies and requirements. First you must understand what FDA requires in terms of data integrity, and what the real-world costs are, whether you are taking proactive or reactive steps. FDA uses the acronym ALCOA to define its expectations of electronic data. The “l” originally stood for legible, which dates back to the time when FDA was dealing with scanned documents. I’ve updated it to “long lasting.”
Attributable
Long-lasting (legible)
Contemporaneous
Original
Accurate
In addition, this is the definition of data integrity that FDA uses for internal training: “Data are of high quality if they are fit for their intended uses in operations, decision-making and planning . . . as data volume increases, the question of internal consistency within data becomes paramount….”
From: Pharma Manufacturing.com