Industries / Regulated manufacturing
Answers the line can act on.
You make regulated product. Quality is measured and audited. Every answer traces to a controlled instruction, the person who approved it, and a date. Cognatum supports quality manufacturing.
Without Cognatum
Which instruction is at the line?
“I approved this once. I should not be answering the same question eleven times a year.”
Before an assistant is allowed near production, quality asks two things: where the answers come from, and whether every plant is on the same revision.
Work instructions, hazard wording and supplier records live in different systems, and the plants keep local copies of all three.
An assistant reading uncontrolled content answers from a superseded instruction and a label revision that was replaced last quarter.
A work instruction is superseded and the line keeps getting answers from the old one, because nothing knows what depended on it. When something has to be traced back, nobody can say which version the line was working to.
Revision C. It replaced the previous artwork and applies to everything produced this year.
No source · no approver · no date
Why this industry
What an audit trail has to show.
Three things decide whether an assistant is allowed into a regulated plant. Each one turns on whether the record behind the answer still exists.
- Documented information. A procedure in force is one revision with one effective date. An answer built on the previous one tells somebody to do the wrong thing correctly.
- Traceability. What went into a lot, and under which instruction, is asked about long after the lot has shipped. Superseded versions are retained, so what an entry said in March is a lookup.
- Supplier controls. What a supplier declared about a material becomes your record too. Served as approved entries, a declaration carries its source and the person who accepted it.
What we will not claim
None of this makes your plant compliant with any standard or regulation, and no software could. Those duties attach to your processes, your records, and your quality system.
What you get is evidence toward them: numbered entries, approvals attached to named people, and a change history for the knowledge your AI answers from. Your quality unit decides how that evidence fits your position.
Which retention period applies to client trade communications?
Entry SOP-4471
- v4 In force
Retention extended to seven years for client trade communications.
D. Whitfield, Records management · 2026-07-02
- v3 Superseded · retained
Chat channels brought into scope.
D. Whitfield, Records management · 2025-11-14
- v2 Superseded · retained
Exception process added for legal hold.
M. Alvarez, Compliance · 2025-03-09
- v1 Superseded · retained
First approved version.
M. Alvarez, Compliance · 2024-06-18
→ what the entry said on a date is a lookup
With Cognatum
Five things that need approving.
What an assistant answers from in a plant is not one kind of thing. Five classes already carry a control duty of their own.
Work instructions
A revision, with a date
A procedure in force is one revision with one effective date. The entry names it, and stops being served when a new one is approved.
Hazard communication
Wording that is fixed
Label and safety data sheet wording is standardised on purpose. It comes back word for word from the current revision, never summarised.
Supplier records
What the supplier declared
Declarations, certificates and approved source records are asked about years later. The entry carries the source and who accepted it.
Traceability
What ran, under which version
Lot and batch questions arrive long after the lot shipped. Superseded entries are retained with the dates they applied.
Corrective action
As recorded, not remembered
How a problem was investigated and closed is knowledge the next investigation needs. It is served the way it was written down.
Why not search
A label is not a search result.
Search finds the document that holds the wording. It cannot promise that what comes back is the wording.
An index points at a file wherever it sits. It can rank that file. It cannot number it, approve it, or record who stood behind it.
A system of record stores the approved answer itself, so the revision, the approver and the date travel with the answer.
Returned word for word
“Causes serious eye damage. Wear protective gloves, protective clothing, eye protection, and face protection. If in eyes, rinse cautiously with water for several minutes.”
D-611 · v4
- Label artwork Unchanged
- Safety data sheet Unchanged
- AI assistant Refused
What was refused
Asked to send “flush with water for a few minutes” in place of “rinse cautiously with water for several minutes”. Rewording approved text is refused, not corrected.
Frameworks
What each framework asks.
| Instrument | What it asks of you | What we supply toward it |
|---|---|---|
| ISO 9001:2015 | That documented information is controlled, and that changes to it are reviewed and approved. | Version history and approval sit on the entry itself, rather than in a spreadsheet that has to be reconciled. |
| OSHA Hazard Communication Standard, 29 CFR 1910.1200 | That hazard information reaches workers through labels, safety data sheets and training. | Fixed wording is returned word for word rather than paraphrased, so a hazard statement cannot drift in the retelling. |
| TSCA and REACH | That substances in what you make are identified, and that what you know travels along the supply chain. | Each declaration is an entry with its source and the person who accepted it, so a supplier answer is traceable rather than remembered. |
| FSMA preventive controls, 21 CFR Part 117 | For food manufacturers, a written plan with monitoring, corrective action and verification records. | Records are produced as the work happens rather than assembled afterwards, and every superseded version is retained. |
| Recall and corrective action programs | That you can establish afterwards what was made, under which instruction, and who was told. | Producing the version that was live on a given date is a lookup, because the entry keeps its versions and its approvals. |
This table describes obligations that fall on your organization, and the evidence Cognatum produces toward them. It is not a claim of certification or conformity, ours or yours.
In practice
What was the line working to?
A quality team is asked which instruction a shift was working to when a batch went out of specification.
They ask, and the answer comes from the revision that was in force on that date, with the approver attached.
Where two approved sources disagree, neither is served as approved. Where a date settles it, the resolution is drafted and queued for approval. Only a real disagreement goes to a named person to settle.
The trail is exported for the investigation, rather than rebuilt from a shared drive and somebody remembering.
Source A · Retention policy v7
Supervisory records are kept for six years.
Source B · Supervisory procedures v3
Supervisory records are kept for five years.
Neither is served as approved
The record settles it
Resolution queued for approval
Entry B supersedes A · Effective 2026-05-01 · queued
A real disagreement
Flag open
Routed to a named person · Records management
Common questions
What quality teams ask first.
What do we show an auditor who asks where an AI answer came from?
The entry. It carries a named approver, an approval date, a version history, and the controlled document behind it. Producing what was live on a given date is a query rather than a search through shared drives.
Do we have to move our instructions into this?
No. Entries are drawn from the systems where work already happens, and each one links back to the document it came from. Your document control system keeps doing its job.
How does hazard wording survive an AI channel?
It is marked as fixed. The text comes back word for word from the current revision, in full, or not at all, and the loop that rewrites everything else skips it.
Does this make our plant compliant with anything?
No, and no software does. What it produces is evidence you can put in front of an auditor: which entry answered, who approved it, when, and from what source. Your obligations stay yours.
An instruction was revised mid-shift. How does the old answer stop?
The moment the new entry is approved it is what the assistant serves, at every plant at once. The old revision is archived with the dates it applied, because a traceability question needs it to still exist.
What happens when a supplier declaration conflicts with our own record?
They are held apart and routed to a person to settle. They are never averaged into one confident answer. A conflict is a decision, so a person makes it.
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