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.
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. |
Important context
LiteLog is deliberately not a system validated under EU GMP Annex 11 or FDA 21 CFR Part 11. It documents alongside your GMP documentation in non-classified areas — for example laboratories without cleanroom classification, technical and storage areas, corridors and offices. For classified cleanrooms and product-contact processes, your client's validated systems remain in charge.