PxR · Review by exception for GxP laboratory data

Review only what needs a human decision.

PxR reads your chromatography, LIMS, ELN and audit-trail exports, flags potential data-integrity exceptions with fixed, documented rules, and records who decided what, when and why.

PxR Home screen showing findings awaiting a decision, counts and the next findings to review
ForQA and laboratory data reviewers in pharma and biotech
DataCDS, LIMS, ELN and audit-trail exports
DeploymentRuns locally — no cloud or integration needed
StatusEvaluation version with a validation-ready pack
Why PxR

Spend review time where it matters

Most laboratory records are clean. The risk sits in the few that were reprocessed, changed after approval or passed only on a retest — and those are the ones a full manual review can miss.

Review by exception

PxR surfaces only the records that need attention, highest priority first, so reviewers stop re-checking everything that is clean.

Every flag explained

32 documented checks — 16 for results and 16 for audit trails — such as a result changed after approval, manual integration with a material change, or an ELN entry edited after signing. Each finding shows its evidence, and checks a source could not support are listed. No black-box model decides.

Decisions you can defend

Every decision needs a reason, is attributed and timed and, in secure mode, electronically signed. Only QA can close a finding, nobody can clear their own, and earlier decisions are kept as history.

How it works

From your exports to a signed decision in four steps

STEP 1

Bring your exports

CSV, Excel, XML or AIA/ANDI files from the systems you already run. The Import Wizard maps your column names once.

STEP 2

Rules flag exceptions

Fixed, documented rules check each result and audit trail and explain exactly why a record was flagged.

STEP 3

A reviewer decides

One finding at a time, with the evidence in order. The reviewer confirms, dismisses with a reason, or opens a case.

STEP 4

Cases and reports

Investigation cases, batch review summaries and the audit trail, ready for QA and management.

Product tour

See what reviewers see

Review queue

One finding at a time, with the evidence in order

Each finding shows what PxR detected, what happened in sequence and the instrument evidence — the chromatogram, the value change and the reason given.

  • Highest-priority findings first
  • The chromatogram beside the decision
  • A reason required for every decision
PxR review queue showing a finding, its event timeline, the chromatogram and the decision panel
Audit trails on their own

Review any audit trail — even without a results file

Bring a CDS, ELN, LIMS, instrument or AI-agent audit trail and PxR checks it against 16 documented audit-trail checks — such as changes after signing, signed records deleted, authors reviewing their own work and AI-agent changes with no human review — wherever the export records the events needed.

  • Vendor audit trails read as exported, or mapped once
  • Every file fingerprinted (SHA-256)
  • “What was checked” shows which checks could run on each source
PxR Audit trails page with findings from a connected-lab audit trail and a recorded decision
ELN entries

See what changed after an entry was signed

For an electronic lab notebook, PxR shows each entry as a card and lets you step through its versions — so a conclusion edited after signing is visible in seconds, beside the values, files, structures and signature timeline.

  • Version slider with a highlighted difference
  • Chemical structures drawn from the record
  • One-click audit-trail review report (PDF) with a sign-off block
PxR ELN entry view showing two versions of an entry and the change made after signing
Instrument evidence

The data behind every finding, not just the audit trail

Every sample appears with its own instrument data — chromatograms, spectra and LIMS or ELN records — so a reviewer can see whether the measured signal supports the reported result.

  • Real chromatograms with detected peaks
  • Samples ordered by the priority of their findings
  • Full chromatography analysis one click away
PxR Evidence view with sample cards showing chromatograms and finding priority
Investigation cases

Investigate across systems, not in silos

When a LIMS result and a GC-MS run belong to the same sample, PxR proposes the link, a person confirms it, and the discrepancy becomes one investigation case.

  • Related findings grouped into one case
  • Timeline, evidence and outcome together
  • Printable case report
PxR investigation case for a LIMS and GC-MS discrepancy
Import Wizard

Your exports, as your systems produce them

Map an audit-trail, LIMS or results export once — any column names, title lines, separators or date formats. PxR validates every row and keeps a traceable import record.

  • CSV, Excel, XML and AIA/ANDI chromatograms
  • Unit conversion only where valid
  • Saved mappings per system and export
PxR Import Wizard for mapping an export file
Reports

Reports for QA and management

Generate a case report, a batch review summary, the audit trail with signatures, or a pilot ROI estimate — all built from the same records reviewers worked on.

  • PDF case and batch reports
  • Audit trail and e-signature report
  • Review-time measurement and ROI estimate
PxR Reports screen
Built for GxP

Designed for regulated laboratories from the start

Tamper-evident audit trail

In secure mode, PxR actions are recorded in a hash-chained log with an integrity check, alongside the source system's own audit events.

Electronic signatures

In secure mode: individual accounts, role-limited signature meanings and signatures bound to the content that was signed.

Controlled ingestion

Validate, preview, confirm, ingest — with a checksum and import record for every file.

Validation-ready pack

User requirements, traceability matrix, OQ test scripts and a supplier test-evidence report to support your own validation for your intended use.

Optional AI, advisory only

Reads only the case's own evidence and never makes a decision. The provider is configurable, and it can be switched off entirely.

Honest status

PxR is an evaluation version and has not been validated for production GxP use. Its documentation is designed to support customer-led validation, not to replace it.

Fits your landscape

Works from the exports your systems already produce

No connectors or system access are needed to start. PxR complements your CDS, LIMS and ELN — it does not replace them.

Chromatography traces — AIA/ANDI (.cdf), CSVPeak and results tablesAudit trails — CSV, Excel, XMLChromeleon, OpenLab, ChemStation and MassHunter audit trailsELN audit trails and entry versionsAI-agent activity logsLIMS results — CSV, Excel, XMLGC-MS peak tables (0–100 and 0–999 match scores)FT-IR / Raman reference data

Exports from Empower, Chromeleon, OpenLab and similar systems are supported through standard export formats, and several vendor audit-trail layouts are read as exported (labelled provisional until tested on your own export). Native vendor raw-data files are not read directly.

Try it yourself

A hosted evaluation copy is available for 2–3 weeks

Work through the demonstration data in your browser — results, audit trails, ELN entries and cases — with a 15-minute test script. Nothing to install; your session is private and deleted automatically. Please do not upload real or confidential data.

Request evaluation access
Free Ghost Pilot

Try PxR on your own historical data — free for 2–3 weeks

How it runs

  • Offline, on an agreed anonymised historical dataset
  • No access to your live systems
  • No integration or IT project

What you get

  • Findings with their evidence
  • Checks performed and unavailable
  • Review time measured on an agreed test
  • An ROI estimate with stated assumptions

What we ask

  • Honest feedback
  • If you are happy, a short case study
Built by practitioners

Designed by people who have done the review

PxR was designed and built by PendragonPharmaTech, drawing on more than 20 years of laboratory informatics, GxP and computer system validation work for leading global pharmaceutical companies — including chromatography data system roll-outs, electronic lab notebooks and regulated data platforms.

Questions

Frequently asked

Does PxR replace our CDS, LIMS or ELN?

No. It reads their exports and adds a review and investigation layer on top of them.

Is PxR validated?

Not yet — it is an evaluation version and has not been validated for production GxP use. Its requirements, traceability and test documentation are designed to support your own validation for your intended use.

Do we need to integrate it with our systems?

Not for a pilot. Exported files are enough; integration can follow later if it makes sense.

Can PxR review an audit trail without results?

Yes. The Audit trails page checks a CDS, ELN, LIMS, instrument or AI-agent audit trail on its own and produces a review report. It also shows which checks your source could support and why others could not.

Does AI make decisions?

No. Detection uses fixed, explainable rules and every decision is made by a person. The optional AI assistant only helps explain the evidence in a case.

More questions and answers

See PxR on your own data

Book a short call to scope a free 2–3 week Ghost Pilot.

contact@pendragonpharmatech.com