Meet neil.
Start with procedures, master batch records, forms, or spreadsheets. neil proposes the build as a change set. Your team reviews and signs. Your operators execute the approved workflow, with audit trails and e-signatures built in.
He reads it. You sign the change set.
Start with a document and neil proposes the templates, fields, workflows, review gates, and validation checks it describes. Nothing goes live on neil's say-so: every proposal is a change set with a full diff, and the validation pack is generated from the build. Once signed, the live workflow changes only through another signed change set.
4.1Confirm chain of identity: apheresis COI-2214 matches the patient and order before any disposition step.
4.2Verify transduction efficiency ≥ 20% CAR+ (vector LV-118) and viability ≥ 70% against the release specification.
4.3Confirm sterility, endotoxin, and potency results are on file and within specification. Record all lot numbers.
5.1Verify potency is 250–600 pg/mL. A second reviewer shall independently verify each release result.
6.1Record all values in the release record. QA disposition is required before the product is released.
ready to run.
What neil does all day.
01Reads your regulatory docs
Validation reports, CTD modules, approved specs. The output is structured data: specs, test names, acceptance criteria, methods. Not summary text.
02Configures your Blueprints
Describe your operation — sterile injectables, three lines, FDA + EU Annex 1 — and neil drafts the configuration. Your team reviews and approves.
03Drafts your investigations
OOS, deviation, and CAPA first drafts with context pre-populated and likely causes surfaced from your history. Investigators start with hypotheses, not blank pages.
04Surfaces the patterns
Parameter drift across batches, recurring root causes, training gaps. Signals from live execution data, before they become findings.
neil drafts. Your team signs.
Regulated work keeps humans in the loop. Seal enforces it: every proposal waits for review and an e-signature before it goes live. After publication, execution follows the approved workflow until another change set is signed.
The engine is serious. The namesake is not.
neil is named after Neil the Seal, the Tasmanian elephant seal famous for blocking roads, stealing traffic cones, and ignoring authority entirely. Ours reads procedures and respects review gates. Both are beloved. Only one is under change control.
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