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Life Sciences

From assay to batch release, the record is the proof. Verified AI on GxP data.
industrieslife sciences

From assay to batch release, the record is the proof.

A potency result, a dissolution profile, a stability trend, a batch yield: in GxP work, a number without its chain of custody is not a result. Xorq lets agents work across your ELN, LIMS, MES, and QMS while every figure keeps its assay method, its validated dataset version, and its reviewer attached, the way a QA lead or an FDA inspector expects to read it.

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on this page §1One potency result, read the way an inspector reads it §2Chain of custody, discovery to post-market §3Sources, methods, and e-signatures §4Deploying in a validated environment
results xorq keeps traceable
potency · HPLCdissolution profilesstability trends · ICHbioassay titersbatch yield · CPP / CQAimpurity profilestables for CTD module 2
§1One potency result, read the way an inspector reads it

At 09:14 a QA lead asks whether batch 2026-0912-A is within specification for potency, and what changed from the last three lots. The agent answers in plain language, and each number in the answer is a link.

Potency for lot 0912-A is 98.7%1, within the 95–105% specification2. The previous three lots measured 99.4%, 99.1%, and 99.6%1. Two inputs changed for this batch: excipient lot E-3310 came from a new supplier3, and hold time at step 4 ran two hours longer than the validated range4. A deviation has been opened for the hold time; potency remains in specification.

method HPLC-04 v3.25computed 09:14reviewed · R. Ibarra · 09:316

Each superscript resolves to an entry in the Xorq Ledger. The answer and its evidence are the same object.

the query that ran the validated dataset version the method in effect the person who signed
§2Chain of custody, discovery to post-market

The same figure passes through different owners and different systems as a product moves from development to market. Xorq does not replace those systems. It records what was computed from them, by which method, and who accepted it, at every stage.

stagesystems of recordwhat xorq recordswho signs
R&DELN · LIMSExperiment conditions joined to assay results as one versioned expression; reruns replay from cache.Study director
Tech transferLIMS · MESMethod versions promoted with their validation reference; process parameters carried with the definition.Validation lead
ManufacturingMES · QMS · ERPBatch steps, in-process controls, material genealogy; deviations surfaced with step, lot, and operator.QA · batch release
SubmissionWarehouse · SAS · dossierEach table a Ledger entry that regenerates from validated datasets with method and reviewer attached.Biostatistics · regulatory
Post-marketSafety DB · warehouseSignal queries versioned and reproducible; the same definition every period.Pharmacovigilance
§3Sources, methods, and e-signatures

What the superscripts in §1 open. This is the view an inspector would see, read-only, from the same Ledger the agent wrote to.

1potency_by_lot · lims.assays ⋈ mes.batches · filter lot in (0912-A, 0905-A, 0829-B, 0822-A) · computed 2026-09-12 09:14 · cache MISS
2specification · potency · lims.specs · product P-114 · 95.0–105.0% · effective 2025-11-03
3material genealogy · erp.material_lots · E-3310 · supplier changed from A to B · received 2026-09-08
4deviation DEV-2026-0912-01 · mes.batch_steps · step 4 hold 6h 02m vs validated 2–4h · opened by agent, owned by QA
5method HPLC-04 v3.2 · promoted 2026-06-01 · validation VAL-2026-041 · change control CC-1187
6review · release · QA e-signature · R. Ibarra · 2026-09-12 09:31 · identity provider: your SSO
AttributableEvery value and every approval is a commit signed by a named person. An agent can compute a result; only a human can release it.
ContemporaneousTimestamps come from execution. Nothing is filled in after the fact.
Original and legibleThe result is stored with the query, dataset versions, and method that produced it.
ReproducibleRecompute from versioned inputs and get the same figure, on demand.
§4Deploying in a validated environment

Xorq deploys in your VPC or on a qualified workstation. It reads from LIMS, ELN, MES, QMS, and ERP through their existing interfaces and writes only to its own Ledger. Method and definition changes flow through your change control; signatures come from your identity provider.

We usually start with one table from a recent submission or one batch record. Your QA or biostatistics lead picks it, and in a working session we show it as a Ledger entry: how it regenerates from source, who would review it, and what an inspector would open.

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