Resources

Material for the people who have to justify this internally.

Evaluation guides, qualification checklists, the numbers we use and the standards we build against. Written for an MSAT engineer making the case to a site director and a QA lead, not for a brochure.

Ask for a document Scenario studies

GuidesChecklistsStandards

run_b2c7e1 · agent graph · scenario 10 nodes · 1 QA approval gate
01 · orchestrator ingest.batch_record ✓ SUCCEEDED 02 · orchestrator twin.rehearse ✓ SUCCEEDED 03 · blend_dispense blend.uniformity ✓ SUCCEEDED 04 · granulate_dry granulate.dry ✓ SUCCEEDED 05 · compress_fill compress.press ✓ SUCCEEDED 06 · coat_dry coat.spray ✓ SUCCEEDED 07 · defect_inspect inspect.tablets ✓ SUCCEEDED 08 · quality_potency spectra.release_evidence ✓ SUCCEEDED 09 · orchestrator approve.qa ◆ APPROVAL 10 · quality_conf release.genealogy ✓ SUCCEEDED

Scenario: Run one immediate-release tablet batch through granulation, compression, coating and inspection inside the approved design space, with QA approval before release. A design walkthrough, not a customer record.

Guides

Evaluation guides

Each is available on request as a document your team can circulate.

Guide

Choosing the wedge workflow

Compression plus inspection, PAT-based blend release, coating optimisation or tech transfer: how to pick by reject cause, release pain and integration access.

Guide

Running a shadow-mode baseline

What to capture (rejects, deviations, yield, energy, release time), for how long, and how to compare predictions with QC results fairly.

Guide

Autonomy in a validated plant

The four levels, what changes at each, what never changes, and how to write the policy so QA can sign it.

Guide

The Part 11 audit trail

Schema, hash chain, e-signatures, retention and export: what an inspector will ask and how the trail answers.

Guide

Validating a learning system

Model cards, golden datasets, change control, drift monitoring and how a model version becomes a GxP record.

Guide

Working with the batch twin

What a formulation- and tooling-specific twin needs, how accuracy targets are set per family and how the design space is exported.

Tools

Checklists

From the qualification criteria and the MVP success metrics.

Design-partner qualification

  • Sufficient production volume or product value for a clear ROI
  • Compression, coating or granulation, PAT, NIR or vision, and MES with API access
  • Executive mandate to raise yield or cut rejects and deviations, or to adopt continuous manufacturing or RTRT
  • Willingness to run a validated paid pilot with a defined success metric
  • An MSAT champion and a QA reviewer with weekly time

Pilot success metrics

  • Content-uniformity, potency and defect accuracy against QC and the formulator baseline
  • Yield and first-pass quality improvement
  • Reject, deviation and energy reduction
  • Release-time reduction and consistency improvement
  • One hard ROI metric tied to pricing, agreed in writing
Run timeline · scenario

The worked example

The scenario run used in every guide. Each guide refers to its steps by number.

run_b2c7e1 Line 2 · rotary tablet press · scenario SUCCEEDED
  1. 01 ingest.batch_record SUCCEEDED 1.2 s

    Plant Orchestrator · Pulled the master batch record, the approved design-space limits for this formulation and tooling family, and the site autonomy policy from MES; locked the target envelope for the run.

  2. 02 twin.rehearse SUCCEEDED 41 s

    Plant Orchestrator · Twindra simulated 36 candidate setpoint vectors on the as-made batch twin (granulation DEM, compression and ejection risk, coating CFD, dissolution surrogate) and ranked them on predicted content uniformity, capping risk and takt.

  3. 03 blend.uniformity SUCCEEDED 6 m 10 s

    Blend-and-Dispense · Spectryn scored in-line NIR spectra against the formulation's chemometric model; the blend reached its uniformity end point with confidence bounds inside the site acceptance limit and blending stopped on evidence rather than on a fixed time.

  4. 04 granulate.dry SUCCEEDED 3 m 48 s

    Granulate-and-Dry · Inlet air temperature and drying airflow trimmed inside the approved window to bring loss-on-drying to the target moisture band for compression; the move was bounded, logged and inside the design space.

  5. 05 compress.press SUCCEEDED 2 m 02 s

    Compress-and-Fill · Main compression force and feed-frame speed adjusted inside the approved window to hold tablet weight and hardness on target while the twin's capping-risk estimate stayed under the site threshold.

  6. 06 coat.spray SUCCEEDED 4 m 25 s

    Coat-and-Dry · Spray rate and inlet temperature re-phased against bed temperature and exhaust humidity to hold the film-coat window and avoid twinning and mottling; no excursion from the validated recipe envelope.

  7. 07 inspect.tablets SUCCEEDED continuous

    Defect-and-Inspect · Visqa classified chips, cracks, capping, spots, mottling and print defects on six synchronised cameras, within the sub-100 ms design budget, and linked a rising chip rate to coating spray rather than to tooling.

  8. 08 spectra.release_evidence SUCCEEDED 38 s

    Quality-and-Potency · Spectryn assembled the method-linked evidence chain for content uniformity and moisture with confidence bounds and citations to the validated analytical method, ready for QA review.

  9. 09 approve.qa APPROVAL 3 m 14 s

    Plant Orchestrator · Batch release is above every autonomy level Pildeon offers. The package was held for the named QA reviewer, who approved it in the review console; the decision, the reviewer identity and the timestamp are in the Part 11 audit trail.

  10. 10 release.genealogy SUCCEEDED 52 s

    Quality-and-Conformance · Conforma wrote the time-aligned batch genealogy (every sensor state, recommendation, approved action, equipment response and QC result) and the cited release package to the immutable audit trail.

Tool calls · scenario

The agent shows its work

Every tool invocation, argument and result is written to an immutable, human-readable log, and every reasoning step is expandable. Nothing about a run is hidden from the plant or from QA.

tool-call stream · run_b2c7e1
  1. 06:12:04mes.read_batch_record({ line: "L2", product: "IR tablet · family A" })
  2. 06:12:05ok design space loaded · autonomy policy L2 · QA reviewer assigned
  3. 06:12:06twin.simulate({ candidates: 36, horizon: "full batch" })
  4. 06:12:47ok candidate #14 selected · predicted CU inside limit · capping risk under threshold
  5. 06:12:48policy.evaluate({ candidate: 14, autonomy: "L2" })
  6. 06:12:48ok 5 setpoint moves inside design space · release held for QA
  7. 06:12:49nir.score({ probe: "blender-1", model: "cu-famA-v3" })
  8. 06:18:59ok blend end point reached · confidence bounds inside acceptance limit
  9. 06:19:00plc.write_setpoint({ tag: "FBD1.INLET_T", within: "design space" })
  10. 06:22:48ok loss-on-drying in target band · move logged to audit trail
  11. 06:22:49press.write_setpoint({ tag: "TP2.MAIN_FORCE", within: "design space" })
  12. 06:24:51ok weight and hardness on target · capping risk under threshold
  13. 06:24:52vision.stream({ cameras: 6, model: "visqa-defect-v2" })
  14. 06:27:10chip rate rising on camera 4 · attributed to spray rate, not tooling
  15. 06:27:11coater.write_setpoint({ tag: "CT1.SPRAY", within: "design space" })
  16. 06:29:14ok chip rate back to baseline · film window held
  17. 06:29:15nir.evidence_chain({ attributes: ["cu", "moisture"], method: "validated" })
  18. 06:29:53ok evidence chain assembled · citations attached
  19. 06:29:54approval.request({ action: "batch_release", reviewer: "QA" })
  20. 06:33:08ok approved by the named QA reviewer · identity and timestamp logged
  21. 06:33:09audit.write_release_package({ batch: "B-240918", genealogy: "full" })
  22. 06:34:01ok scenario complete · genealogy written · package cited

Reasoning trace

Plan, thought, action, observation, exactly as the orchestrator records it.

GoalRun one immediate-release tablet batch through granulation, co…

Run one immediate-release tablet batch through granulation, compression, coating and inspection inside the approved design space, with QA approval before release.

PlanRehearse on the twin first. Stop blending on NIR evidence rath…

Rehearse on the twin first. Stop blending on NIR evidence rather than on a fixed time. Trim drying, compression and coating only inside the approved design space. Inspect continuously. Hold release for the named QA reviewer, always.

ThoughtThe fixed recipe blends for a set time regardless of what the …

The fixed recipe blends for a set time regardless of what the spectra say. On the twin, the candidate that stops on evidence and trims inlet temperature before compression keeps content uniformity and moisture inside their limits with the lowest predicted capping risk.

Actiontwin.simulate(candidates=36) → candidate #14: evidence-based b…

twin.simulate(candidates=36) → candidate #14: evidence-based blend end point, bounded drying trim, compression force held inside the window, spray rate re-phased to bed temperature.

ObservationEvery candidate that pushed turret speed for takt raised predi…

Every candidate that pushed turret speed for takt raised predicted capping risk above the site threshold and was discarded. Rate is never traded for a quality attribute.

ActionExecute candidate #14 under autonomy level L2: five setpoint m…

Execute candidate #14 under autonomy level L2: five setpoint moves inside the design space, each logged. Batch release routed to QA.

ObservationChip rate rose on camera 4 at 06:27:10. Visqa attributed it to…

Chip rate rose on camera 4 at 06:27:10. Visqa attributed it to coating spray rather than tooling; a bounded spray-rate trim returned it to baseline in about two minutes.

OutcomeScenario complete. Every move inside the approved design space…

Scenario complete. Every move inside the approved design space, the QA approval recorded with identity and timestamp, and the cited release package written by Conforma to the immutable audit trail.

Numbers

Numbers used across the resources

Market figures from the market analysis, prices from the price list, and design targets from the architecture. Nothing here is a measured customer result.

$18BTotal addressable market: OSD automation, PAT and vision, continuous-manufacturing control, pharma MES, growing about 13% a year
$4.6BServiceable market: autonomous compression and coating control, content-uniformity and defect sensing, batch twins
$270MObtainable within three years, by land-and-expand across lines, plants and sites
$17,000Line tier per compression, coating or granulation line per month; Plant $100,000 per month; Enterprise custom
Reading

Background reading

The standards and guidance Pildeon is built against. Read the originals.

Regulation

21 CFR Part 11

Electronic records and electronic signatures: the audit trail, e-signature and retention requirements the platform is designed to meet.

Guidance

GAMP 5 (second edition)

Risk-based computerised system validation, including guidance on AI and machine learning in GxP systems.

Guidance

ICH Q8, Q9, Q10, Q13

Pharmaceutical development, quality risk management, pharmaceutical quality system, continuous manufacturing.

Compendium

USP general chapters on uniformity and dissolution

The reference methods Spectryn's and Twindra's targets are stated against.

Data integrity

ALCOA+ principles

Attributable, legible, contemporaneous, original, accurate, plus complete, consistent, enduring, available.

Industry

Continuous manufacturing and RTRT literature

Regulator-endorsed continuous manufacturing and real-time release testing, the shift that makes in-line evidence valuable.

Evaluation

A sane evaluation sequence

Six steps, in order, none skipped.

  1. Name the number. Rejects, deviations, release time, energy, yield or rate. One.
  2. Pick the wedge that moves it, and the line.
  3. Inventory the stack for that line: equipment, PAT, vision, MES, LIMS, historian.
  4. Bring QA and validation in before the first connector, not after.
  5. Shadow and baseline. Compare predictions to QC. Decide on evidence.
  6. Write the metric before any money changes hands.
Autonomy

Four levels, set per agent and per setpoint

A tablet plant does not go from fixed recipes to autonomy in one step, and validated parameters never change without sign-off. Pildeon makes the level explicit, auditable and reversible at any time.

Autonomy levels and the human role at each
LevelWhat the agent doesWhat the human doesTypical time to reach
L0 · ShadowObserves, scores and predicts; writes nothingRuns the line as today; compares predictions to QC resultsWeeks 1 to 6 of a design partnership
L1 · AssistRecommends setpoint moves and explains whyProcess engineer enters the move; QA reviews the logAfter shadow-mode accuracy is shown
L2 · SupervisedProposes a bounded move; it executes on approvalApproves each move in the review consoleAfter assist-mode ROI is shown
L3 · BoundedMoves low-risk compression, coating and inspection setpoints inside the approved design spaceHandles exceptions; approves every releaseAfter validation and change-control review

There is no unattended level. Batch release and any move outside the approved design space always wait for a named QA reviewer, and every model or prompt change runs under GxP change control.

Guardrails

An agent that can move a compression force needs a leash

Pildeon writes to production equipment in a GMP plant. Every capability is scoped to the approved design space, every write is policy-checked, every action is written to an immutable Part 11 audit trail the site owns, and no agent can release a batch.

  • Bounded action space. Each agent can only write to an explicit setpoint allow-list, inside the limits the site's validation approved.
  • Policy engine before every write. Autonomy level, design-space limits, batch state, model version and reviewer assignment are all evaluated before a setpoint moves.
  • Human-in-the-loop gates. Batch release, any move outside the design space and any change to a validated parameter wait for a named QA reviewer.
  • Immutable audit trail. Append-only, hash-chained, exportable, retained on the site's own storage, with reviewer identity and timestamp on every decision.
  • Hard fallback. Loss of the edge node, the network or the model returns the line to the equipment's last known-good recipe.
  • Tenant and IP isolation. Formulations, recipes and models never cross a customer boundary. Validated on-prem deployment is available for regulated producers.

Compliance posture

StandardScopeStatus
21 CFR Part 11Audit trail, e-signatures, records RUNNING Designed in from day one
GAMP 5Validation package for the platform RUNNING In progress, planned for the first design partners
cGMP · ICH Q8 to Q13Design space, QbD, continuous manufacturing RUNNING Design-aligned; site validation decides
SOC 2 Type ICloud control plane QUEUED Planned, first six months
SOC 2 Type IICloud control plane QUEUED Planned, months six to twelve
Data residencyValidated on-prem, air-gapped option SUCCEEDED Available by design

Read the security and validation overview

Integrations

It speaks tablet plant, not cloud

Pildeon reads and writes through the systems already on the floor: presses, coaters, granulators, PAT probes, MES, LIMS and historians. No rip-and-replace, no parallel historian. Connectors are built with design partners against their stacks; the vendors listed are the ones common in OSD plants.

Blending and granulation

GEA, Glatt, Syntegon, Freund-Vector, L.B. Bohle

Blender, granulator and fluid-bed telemetry; bounded setpoint writes

Tablet presses and fillers

Fette Compacting, Korsch, IMA, Syntegon, MG2

Force curves, fill depth, ejection force; bounded setpoint writes

Coating systems

GEA, Glatt, O'Hara, Thomas, Freund

Spray, inlet, bed temperature, exhaust humidity; bounded writes

PAT and NIR

Bruker, Sartorius, Viavi probes and analysers

Spectra across blend, granulation, drying and compression

Vision

Line cameras and existing inspection systems

Frames, defect maps, reviewed images

Pharma MES and eBR

Körber Werum PAS-X, Rockwell, Siemens Opcenter

Master batch records, campaigns, batch genealogy

LIMS and historians

Site LIMS, OSIsoft PI and equivalent historians

QC results, time-series backfill and replay

Identity and edge

Azure AD, Okta, LDAP · NVIDIA Jetson and on-prem GPU

SSO, RBAC, named approvers · inference at the line

See all integrations

The first meeting

What each stakeholder asks first

Pildeon has no customer quotes to show yet, and will not invent any. These are the questions the three buyers in an OSD plant ask in the first meeting, and the answer each gets.

"What does this do to my reject rate, my deviation count and my release time, and how will you prove it on my line rather than on a slide?"

Site or manufacturing director · economic buyer

Answer: shadow mode first, baseline captured before any autonomous action, a written ROI target before a paid pilot.

"Will it ever move a setpoint outside the design space we validated, and can I see why it recommended every move it made?"

Formulation or process engineer (MSAT) · champion

Answer: no, by construction. Every recommendation carries its reasoning trace and its citation.

"Where is the Part 11 audit trail, who signs the release, and what happens to my validated state when the model changes?"

QA, quality and compliance lead · approver

Answer: an immutable audit spine, a named QA reviewer on every release, and every model change under GxP change control.

FAQ

Straight answers

The questions site directors, MSAT engineers and QA leads actually ask in the first meeting.

Yes, but only inside an explicit setpoint allow-list bounded by the design space your validation approved, and only at the autonomy level your site has set. Level 0 is shadow mode: Pildeon observes and predicts and writes nothing. Most sites spend their first weeks there.

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Tell us which guide or checklist and who it is for. We will send the current version.

Book a line review Scenario studies