The GxP operating system. Learns from every run.

Seal replaces paper, spreadsheets, and legacy software with one system to run and record GxP work. Its AI, neil, learns how your operation works and proposes changes — your teams decide what goes live. A medicine made for every person.

Get your first process running in 48 hours.

Start with the process that matters most. Then expand one governed process at a time until execution, records, validation, training, and change control live together. QA approves every release.

See the 48-hour build
QA-PROC-014 / CAR-T release
Build plan
T+00:00
Start with one procedure

Our sample to start, or yours under NDA.

Source
QA-PROC-014 v00
18 pages
3 attached forms
2h 30mneil builds
T+02:30
neil proposes the build

Steps, checks, and gates from your own clauses.

Proposed
42 steps
18 in-line checks
6 QA gates
23h 30myour review
T+26:00
Your team reviews and signs

No release without signed human approval.

Reviewed
3 reviewers
11 comments closed
2 e-signatures
22htraining + evidence
T+48:00
Live, with evidence

Evidence built in; execution gated on training.

Live
v01 sealed
12 operators trained
3 runs open

One record holds the whole run.

Materials, readings, signatures, deviations, and release decisions stay tied to the work that produced them — one complete record, from raw material to release.

How neil connects it
One connected ontology
9 types / 10 relations
Inputs, run records and proof connected through one CAR-T runINPUTSRUNPROOFchain of identitystarting materialmaterial lotperformed byexecuted ontest resultexceptiondispositionsupportsresolved beforePATIENT×217COI-2214Enrolled 04 JunAPHERESIS×217AP-2214Collected 06 JunVECTOR×14LV-118Lot releasedOPERATOR×28S. ReyesTrained on v04INSTRUMENT×9Prodigy-3Qualified 12 MarPOTENCY×217412 pg/mLSpec ≥ 350DEVIATION×19DEV-08Closed, no impactRELEASE×217QA ✓M. Chen 14:31CAR-T RUNPatient 217Executed 26 Jul / v04Inputs, run records and proof connected through one CAR-T runINPUTSRUNPROOFPATIENT×217COI-2214Enrolled 04 JunAPHERESIS×217AP-2214Collected 06 JunVECTOR×14LV-118Lot releasedOPERATOR×28S. ReyesTrained on v04INSTRUMENT×9Prodigy-3Qualified 12 MarPOTENCY×217412 pg/mLSpec ≥ 350DEVIATION×19DEV-08Closed, no impactRELEASE×217QA ✓M. Chen 14:31CAR-T RUNPatient 217Executed 26 Jul / v04

Validated doesn't mean frozen.

Legacy stacks turn every improvement into a revalidation project. In Seal, execution, validation, training, and records live together, so one change set carries the whole change — and the live process moves one governed version at a time.

How changes stay validated
QA-PROC-014 / CAR-T release
v04 live
11m 32s
From neil’s proposal to live
Procedure1 of 6 steps changed
04
Sterility / endotoxin
05
Potency in specification
06
QA disposition / release
v03
QA shall review every completed batch record in full before disposition.
v04
QA shall review by exception. Records with no deviation and all controls in specification release on the operator's e-signature.
What the change carried
Revalidation
34 checks re-run, all passed
Training
12 reviewers gated until retrained
Approval
Marcus Chen, QA, 26 Jul 14:31
In flight
New runs on v04; 3 open runs finish on v03
v01
12 Mar
Initial release
v02
28 Apr
Rapid sterility
8m 41s
v03
09 Jun
In-line potency
14m 02s
v04
26 Jul
Review by exception
11m 32s

Every run improves the next.

A batch stalls. Then another hits the same exception. neil connects the run records, deviation and approvals, drafts the governed change, and — once QA signs it — every later run inherits the fix.

How neil works
QA-PROC-014 / CAR-T release
217 runs / 3 approved changes
Release time falling as governed process changes accumulatev01baselinev02rapid sterilityv03in-line potencyv04review by exception28d21d14dTARGETPT-001PT-217PT-218PREDICTEDRelease time falling as governed process changes accumulatev01v02v03v0428d21d14dTARGETv02 / rapid sterilityv03 / in-line potencyv04 / review by exceptionPT-001PT-217PREDICTED

Friction is not rigor.

Medicine needs proof before it reaches patients.

Paper and document tools turn that proof into rework: retyped values, reconstructed evidence, disconnected review.

Teams run the work in Seal, which captures the proof inside it — as it happens, not after.