Compliance Knowledge Base
The "why" behind the controls — explained simply, then by business reasoning, regulatory reasoning, and exactly how Trialion implements it. Search or browse.
In plain terms
So you can always answer who did what, when, and why — and prove it later.
Business reasoning
Trials are inspected. Without a reliable record of every change, a sponsor cannot defend its data or pass an audit, which can invalidate a study.
Regulatory reasoning
21 CFR 11.10(e) requires secure, computer-generated, time-stamped audit trails that record entries and changes without obscuring previous values.
How Trialion implements it
Every change queues an event in the same transaction as the change, and the worker appends it to a hash chain: the time (the server's), the actor and their roles, the origin, the before and after values, and the reason. Data changes are recorded per field, so a first entry and a later correction are distinguishable. A successful read is not recorded.
Reference: 21 CFR Part 11 §11.10(e) · ICH E6(R3)