Data Integrity & ALCOA+
ALCOA+ stands for the nine data integrity principles applied to records in regulated environments: Attributable, Legible, Contemporaneous, Original, Accurate — plus Complete, Consistent, Enduring and Available. Authorities such as the FDA, EMA and WHO apply these criteria during GMP and GxP inspections. LiteLog documents according to the ALCOA+ principles and thereby supports you with ALCOA+-compliant documentation processes — for example when you work for pharmaceutical, laboratory or other regulated clients.
:::info Plan The audit-proof audit trail in line with ALCOA+ and 21 CFR Part 11 belongs, together with the digital signature, to the Compliance add-on (€49 per month; included in the Enterprise contract) — see Choose a plan. The data-handling fundamentals described on this page — server-side timestamps, immutable originals, correction instead of overwriting — apply in every plan regardless. :::
What is this page for?
This page explains how LiteLog implements the ALCOA+ principles in its data handling and how LiteLog fits into a validation under EU GMP Annex 11 or FDA 21 CFR Part 11. The requirement-by-requirement mapping — clause, LiteLog feature, evidence — is on the page Conformance 21 CFR Part 11 & Annex 11.
How LiteLog implements the individual principles
| Principle | Implementation in LiteLog |
|---|---|
| Attributable | Every action is logged with the signed-in user, timestamp and context. On-site captures are attributed to person and place via NFC, QR or GPS. |
| Legible | All histories can be viewed in the portal and exported as PDF reports. |
| Contemporaneous | Capture happens in the moment of the activity. In addition, the server assigns its own receipt timestamp, independent of the device clock. |
| Original | Stored entries are not overwritten. A correction creates a new record referencing the original. |
| Accurate | A change reason is mandatory when editing or deleting time entries. Every change stays visible with user, time and reason. |
| Complete | Entries arriving late (e.g. after offline periods) are preserved and never discarded. |
| Consistent | Server-side timestamps keep the event chain chronologically coherent. |
| Enduring | Logs and histories are preserved even when properties or structures are reorganised. |
| Available | Evidence is available at any time, filtered by property, area and period, as an export. |
Beyond the mandatory change reason, corrections can be put under approval: with change control switched on, a correction to a report or an incident only takes effect once a second authorised person approves it. Request, reason and decision stay separately traceable, and the original keeps its state until approval.
The same workflow can be applied to the settings that govern how things are captured — form templates, task rhythms, and roles and permissions. A setting under approval is not written until the decision; until then only the reviewed state applies and takes effect, on the devices as well.
Important context
LiteLog is not a pre-validated system; validation (IQ/OQ/PQ) is performed by the operator within their quality system. LiteLog provides supplier evidence for it: a conformance matrix, automated test evidence, the audit trail and the signature manifest. The conformance matrix mapping every requirement of 21 CFR Part 11 and EU GMP Annex 11 to the LiteLog feature and its evidence is available under Conformance 21 CFR Part 11 & Annex 11.
The typical use is documentation alongside your GMP documentation — for example in laboratories without cleanroom classification, in technical and storage areas, corridors and offices, as well as in airlocks and cleanrooms as far as your quality system has validated LiteLog for them. For product-contact processes, the systems validated for that purpose by your client remain in charge.