Biotechnology AI agent · OOS & OOT
Out-of-Specification & Out-of-Trend Investigation AI Agent
Set out the investigation record behind a failing result — the assessment evidence, the instrument and audit trail, the hypothesis and the trend — for the analyst, supervisor and QA who decide.
- Typical delivery
- 4–6 weeks
- Deployment
- Your stack
- QA sign-off
- Pre-conclusion
- After launch
- Agent Care
What this agent does
Assembles the file, never sets a result aside
In
- 01
A result comes back outside specification, and the raw data, the sequence around it and the method file are pulled in.
- 02
A result is normalised across the laboratory, chromatography and quality systems, each fact carried with its source.
Reason
- 03
A record is built against the steps FDA sets out for the supervisor assessment in its May 2022 OOS guidance.
- 04
A retained sample is checked for quantity against the retest count your own written procedure fixed in advance.
- 05
A retest is proposed only where the plan naming it is written and dated before the confirmatory run.
Decide
- 06
A prior-occurrence search runs on method, analyst, instrument, column and reagent lot, not on product alone.
- 07
A distributed batch is flagged on day zero, because 21 CFR 314.81(b)(1) runs a three-working-day alert clock.
Out
- 08
A result is set against the trend rule your firm wrote; we located no primary FDA or EU definition of out-of-trend.
- 09
Writes run only inside the approval boundaries agreed at implementation, and never onto a signed investigation.
Product statement
The agent assembles and makes no GMP determination; a named analyst and supervisor assess, and QA signs the conclusion.
Example workflow
One result, failure to sign-off
- 1Result raisedLIMS entry, chromatography data system, stability pull or contract-laboratory report
- 2Evidence assembledRaw data, the injection sequence, instrument logs, retained-sample quantity and prior occurrences
- 3File draftedAssessment checklist, evidence trail, hypothesis, trend picture and confidence
- 4Controls appliedCompleteness checks, retest pre-specification checks, clock checks and confidence threshold
No human action required
Stages 1 to 4 run unaided, and no result is set aside at any of them — the agent is assembling, and the assessors lane opens at the confidence gate.
Goes to the analyst and the supervisor.
Adds a second laboratory read first.
Assessment and sign-off
The file is held with its evidence, its open steps and the confidence.
Sign · Amend · Send for a second read
Signed — conclusion recorded
- 6Laboratory systems updatedOnly where write access and approval policy allow it
- 7Outcome evaluatedAssessment completeness, days to close, invalidations questioned and inspection findings
Amendments
A file reopened later is read by FDA, and what it attacks is the justification, not the number.
What should not run autonomously
Human approval stays in control
Outside the boundary — human approval required
8 items
- Invalidating a result, or setting one aside.
- Assigning the cause of a result.
- Concluding on batch impact or release.
- Judging whether a laboratory error occurred.
Automation boundary
Agent acts unaided
- ✓Assemble the evidence against each step the FDA guidance enumerates.
- ✓Pull the instrument logs and the audit trail around it.
- ✓Search prior occurrences by method, instrument and lot.
- ✓Test the file for completeness and hold it for the assessors to read.
Writes stay inside the boundaries set at implementation, and never onto a signed investigation.
- Averaging an original result with its retests.
- Applying an outlier test to a suspect result.
- Deciding whether a Field Alert report is due.
- Changes to assessment, retest or trend rules.
Example output
One result, annotated
What the agent assembles is attached to the record it was drawn from.
OOS investigation output · single result
Illustrative example- Result
- Assay below limit
- Assembled line
- Two reprocessings and one deleted injection sit in the sequence before this result
- Rule cited
- 21 CFR 211.194(a)(4)
- Time entered by
- Analyst-entered
- Confidence
- 86%
- Deadline
- Thirty business days, by your SOP
As received
Taken from the chromatography, laboratory and instrument systems — nothing on this side is written by the agent.
Evidence used
- Audit trail of the run
- Instrument log
- Retained-sample amount
Why this rule
It is the record rule the data has to satisfy and a person still decides.
What the score decides
Below the configured threshold the file picks up a second laboratory read before it goes up.
Action
SignAmendSend for a second readValue
Where AI adds value
The same four claims, placed at the point in the workflow where each one applies.
Where the value lands
Value 01 – 04
Every result
From the laboratory record
Start where a number already exists
The sample-tracking page owns custody up to the number; this one starts when that number is out of specification.
Only evidence invalidates
No laboratory or calculation error identified, no scientific basis for setting the first result aside. FDA, May 2022.
The clock nobody quotes right
Thirty business days from the occurrence comes from Barr, decided 1993 — not from FDA guidance, which sets no limit.
Build an evidence trail
The result, the assessment it went through and the manager who signed stay on the file.
Integrations
Typical integrations
Five system groups connect to the same agent. Which of them are in scope is decided in discovery.
Laboratory systems
- LabWare
- STARLIMS
- LabVantage
- Sample Manager
Chromatography data
- Empower
- OpenLab
- Chromeleon
- LabSolutions
Quality management
- Veeva Vault QMS
- TrackWise
- MasterControl
- ETQ
Agent
OOS & OOT investigation
- Reads the result
- Assembles the file
- Holds for sign-off
Stability and trending
- Stability programme data
- Trend and control charts
Observability & evaluation
- OpenTelemetry
- Langfuse
- Supported monitoring/evaluation sources
Integration availability depends on the client's existing systems and API access.
Agent controls
Six layers between the model and the file
Six gates in order, the widest first. What passes every one is set out in the map below.
L6 · Outermost — last line of defence
Inward → L1 · closest to the model
- L1 – L2
- Test whether a file may stand
- L3
- Puts the conclusion in QA hands
- L4 – L5
- Keep the result and the assessment behind it
- L6
- Narrows to evidence tracking when signals degrade
How Nestack evaluates it
Evaluate the investigation workflow — not only the signed file.
Coverage runs the whole depth of the workflow, and every layer is cut by slice.
Surface — the file an inspector reads
- E1Final-output evaluationDid the file carry each enumerated step, its evidence and its date?
- E2Step-level evaluationDid the agent use the right result, the right sequence and the current procedure?
- E3Tool evaluationDid it read and write the correct result and the correct field?
- E4Confidence calibrationDo low-confidence files actually attract more supervisor amendments?
- E5Slice evaluationHow does performance change across specific method and test types?
- E6Business outcomeHow many files were reopened, and how many invalidations were later questioned?
Floor — the outcome the laboratory answers for
Failure modes
Where each failure originates in the agent
Seven failure modes, set at the stage in the lifecycle each begins.
Agent lifecycle
Direction of processing →
01 · Retrieval
1 mode
- ET-03
Sequence not pulled
The injections around the failing one never arrived.
Stage gathers
Raw data, instrument logs, audit trail and prior results
02 · Reasoning
2 modes
- ET-04
Cause named too early
Probable laboratory error stands in for evidence.
- ET-06
Trend limits widen
Limits recalculated from data that holds the excursions.
Stage proposes
Checklist, evidence, hypothesis and confidence
03 · Tool / write
2 modes
- ET-02
Clock started at entry
Days counted from the LIMS record, not the occurrence.
- ET-05
Retest count adjusted
A further run appears after the specified number.
Stage writes
Only where write access and approval policy allow it
04 · Output
1 mode
- ET-01
Prior failure missed
The same column chemistry failed three times before.
Stage returns
The file the supervisor reads and QA signs
05 · Change / Version
1 mode
- ET-07
Silent checklist drift
A model or rule change drops an enumerated step.
Stage tracks
Model, prompt, checklist and trend-rule config
- Sev-1 · acts on a signed investigation
- Sev-2 · a result is set aside unsupported
- Sev-3 · evidence degrades, file holds
Affected slices
The failures concentrate in a few methods
A laboratory-level assessment-completeness figure can read as settled while a few methods carry most of the amendments and the questioned invalidations. Nestack reports the amendment rate by method, not only in total.
Slice performance — reported separately, not only in aggregate
Illustrative example| Slice | Failure rate | Lift | Lift vs. threshold | Status |
|---|---|---|---|---|
| Microbiological and sterility tests | 9.7% | 3.7× | Review | |
| Stability-programme timepoints | 7.1% | 2.7× | Review | |
| Dissolution and content uniformity | 4.2% | 1.6× | Watch | |
| Routine HPLC assay tests | 1.6% | 0.6× | Normal |
Bar: amendment-rate lift vs. the routine HPLC assay baseline · scale 0–4.0× · tick marks the 2.0× review threshold
2 of 4 slices over threshold
Evidence-linked improvement
A cycle ends where a new test starts
A cycle is done when the unsupported invalidation has become a case the next release must pass. That suite is what the next result worked is measured against.
Improvement cycle · five stages
Switchback — the path turns at Improve and returns at Learn
- 01
Detect
Amendment rate rises in one method.
- 02
Diagnose
The result that failed once and was never allowed to fail again is read back until the cause narrows to one.
- 03
Improve
Stamp the change; the results behind it are filed under that number.
- 04
Verify
Each touched result case is run again, and one red stops the release.
- 05
Learn
It stays a standing test, and the assessment rules move with it.
Learn → Detect
The return edge. The next detection runs against a suite one case longer.
Typical build scope
Twelve workstreams across six weeks
The build scope read against the delivery timeline. Week structure follows the six-week plan — discovery, sources, investigation workflow, evaluation, integration, then production validation and handover.
Workstream
Week 1Week 2Week 3Week 4Week 5Week 6
- 01Investigation workflow discovery and boundary work.Week 1
- 02Laboratory and CDS source assessment.Week 1, Week 2
- 03Assessment, retest and trend-rule procedure mapping.Week 1, Week 2
- 04Result ingestion and evidence mapping.Week 2
- 05Assembly logic and source binding.Week 2, Week 3
- 06Confidence scoring and exception routing.Week 3
- 07Analyst and supervisor sign-off workflow.Week 3, Week 4
- 08Laboratory and CDS integration.Week 5
- 09Assessment and trend cases.Week 4, Week 5
- 10Guardrails and invalidation controls.Week 4
- 11Result-trail instrumentation.Week 5, Week 6
- 12Deployment, documentation and Agent Care handover.Week 6
12 workstreams · 6 weeks · bar shows the weeks a workstream is active — several run in parallel
Final scope and sequence confirmed in discovery
Engagement tiers
What each tier includes
Rows are the capabilities named in each tier's scope. Higher tiers include everything below them.
| Capability✓ in scope · — not at this tier | PilotOne laboratory, one method | ProductionProduction laboratory systems | AdvancedMultiple sites / laboratories |
|---|---|---|---|
| Introduced at Pilot | |||
| Assembly to your result record | ✓ | ✓ | ✓ |
| Assessment sign-off | ✓ | ✓ | ✓ |
| Assessment-completeness baseline | ✓ | ✓ | ✓ |
| Introduced at Production | |||
| Reporting by method | — | ✓ | ✓ |
| Sign-off workflow in your systems | — | ✓ | ✓ |
| Approved write-back | — | ✓ | ✓ |
| Laboratory-system integration | — | ✓ | ✓ |
| Introduced at Advanced | |||
| Complex trend-rule sets | — | — | ✓ |
| Multi-stage laboratory sign-off | — | — | ✓ |
| High result volume | — | — | ✓ |
| Multi-laboratory investigation controls | — | — | ✓ |
| Build price | From $5,000 | From $8,000 | Custom quote |
- Final build price
- Confirmed after discovery based on integrations, workflow complexity, transaction volume, approval controls and deployment requirements.
- Separate from build
- Build pricing is separate from recurring Agent Care, which covers managed monitoring, evaluations, incidents and verified improvements after launch.
What we need from you
What you bring, and what we build with it
Each input maps to a piece of build scope and a week in the delivery timeline.
You bring
We build with it
01Your result record structure and procedures
→Result ingestion and evidence mapping
Week 102Representative closed OOS files
→Assembly baseline, checklist extraction and source binding
Week 203Your assessment, retest and trend procedure
→Procedure mapping and automation-boundary definition
Week 104Access to relevant APIs, feeds or exports
→Laboratory, CDS and quality assessment, then integration setup
Week 205Results you would not want re-tested
→Hypothesis cases and the evaluation suite
Week 406What no invalidation may rest on
→Confidence scoring, exception routing, guardrails and sign-off controls
Week 307Named analysts and supervisors to assess
→Assessment sign-off workflow, then pilot and production validation
Weeks 5–6
Nothing else is required
Deployment, documentation and Agent Care handover are ours.
Delivery timeline
Four phases across six weeks
The widths follow the weeks the work actually occupies, which is the only reason week five overlaps.
Phase
W1
W2
W3
W4
W5
W6
- DiscoveryW1
- BuildW2 – W3
- EvaluateW4 – W5
- Pilot & LaunchW5 – W6
Week focus
W1Investigation discovery, procedure mapping and the automation boundary
W2Laboratory-system integration and the assembly baseline
W3Assembly workflow, confidence logic and sign-off controls
W4Evaluation suite, guardrails and failure-mode testing
W5CDS and stability integration, pilot results and targeted corrections
W6One investigation cycle run under the QA manager, then Agent Care handover
- Reading the band
- Each bar spans only the weeks its own work is named in. The week 5 overlap is two phases running, not padding.
- At the end of W6
- Validation closes on live results, and Agent Care picks up monitoring.
- Duration
- Six-week plan shown · typical delivery 4–6 weeks depending on scope confirmed in discovery.
Next step · Biotechnology AI agent
Build an out-of-specification investigation agent around your laboratory.
Show us your OOS procedure, your chromatography system and who signs. Not an FDA rule. Thirty business days, from the occurrence of the problem, held in United States v. Barr Laboratories, 812 F. Supp. 458, decided in the District of New Jersey on 30 March 1993 — a district decision, not national precedent, and absent from FDA May 2022 OOS guidance, which sets no numeric limit at all. It binds a firm because the firm wrote it into its own procedure, and 21 CFR 211.22(d) requires that written procedures be followed. Invalidating a result, naming its cause and concluding on the batch stay with your analyst, your supervisor and your quality unit. Draft EU/PIC/S GMP Annex 22 — consultation closed 7 October 2025, no final text located as at 20 August 2026 — says generative models should not be used in critical GMP applications, and this agent is built so that it is not one. If your quality-event work starts at the deviation, this page is the laboratory result before it.
- Typical delivery
- 4–6 weeks
- Deployment
- Your laboratory systems
- QA sign-off
- Pre-conclusion
- After launch
- Agent Care available
Nestack Agents · Out-of-specification investigation
AGT-BT-18 · Agent Care available after launch