Data integrity is
a chain, not a field
ALCOA+ asks whether a record is attributable, contemporaneous and traceable to its origin. In practice that question is asked about one value, and answering it means walking backwards through batch records, deviations, change control and validation documentation.
"This result was released. Show me the chain from the raw value to the release decision."
The raw value sits in an instrument record, the correction in a deviation report, the justification in a CAPA, and the authority to release in an SOP whose current version is two revisions newer than the batch.
Why ordinary search does not get there
The chain crosses systems that were never joined.
LIMS, MES, document management and paper archives each hold one link. The chain exists conceptually and nowhere physically.
Versions matter more than content.
Which SOP version applied on the day of manufacture is often the whole question. An answer that ignores versioning is worse than no answer.
An inspector asks about one batch, not about the process.
General process descriptions do not answer specific questions, and the specific answer has to be reconstructed under time pressure.
A worked example
What is the basis for releasing batch 2026-0417?
- 01Analytical record
Holds the raw value and the instrument identity.
- 02Deviation report DEV-2026-088
Documents the out-of-trend observation and its investigation.
- 03CAPA-2026-031
Records the corrective action and the effectiveness check.
- 04SOP QA-07, revision 4
The revision in force on the manufacturing date, defining release authority.
A release chain with four cited links and the SOP revision that actually applied at the time, rather than the current one.
What ARGUS does here
Version-correct answers
Where several revisions are indexed, answers name the revision they relied on — the difference between a usable answer and an inspection finding.
Cross-system reasoning
Batch documentation, deviations, CAPAs and SOPs are reasoned over together, not searched one system at a time.
No invented links
Where the chain breaks, the break is the output. The system does not bridge a missing link with plausible language.
Validated environment friendly
Deployment on your infrastructure, deterministic retrieval settings, and a full trace per query for qualification purposes.
What it does not do
Stated here rather than discovered in week three of a pilot.
- ARGUS is not a validated GxP system out of the box. Validation is performed by you, for your intended use, in your environment.
- It does not write to your LIMS, MES or eQMS — it reads and reasons.
- It does not make release decisions and holds no signature authority.
- Built and demonstrated scenarios; no production installations in a regulated manufacturing environment to date.
Questions we get asked
How do you handle qualification?+
Is anything sent to a model provider?+
Can it work on paper archives?+
Test it on a question you already lost time on
Bring one question your own documents should be able to answer, and the documents that ought to contain the answer. If the evidence is not there, that is the result — and it is worth knowing before an auditor finds it.