For pharma and CRO biometrics

The system of record for
statistical-programming validation

Verixa tracks every production and QC program file as a 21 CFR Part 11 audit-trailed transaction, with independent double-programming and resource planning, across whatever statistical computing environment you already use.

21 CFR Part 11ALCOA+ GAMP 5Environment-agnostic Double-programming first
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The cost of the status quo

The most important layer of your process is the one nobody owns

Compute lives in an SCE, conformance in Pinnacle 21, documents in Veeva. But the operational truth, which programs are done, what passed independent QC, what changed, and when you can deliver, still lives in spreadsheets that cannot meet Part 11.

× Inspections at risk

The production program updates, QC never re-runs theirs, and a stale output ships. The trail to prove otherwise does not exist.

× Audit prep is a fire drill

Reconstructing who did what, when, and why from email and Excel costs days and still leaves gaps.

× Resourcing is guesswork

No one can see who is overloaded heading into database lock until the timeline already slipped.

The solution in one line

One audit-trailed pane over the tools you already use

Verixa makes the production-to-QC pair the first-class object, enforces the workflow, and rolls it up into delivery and resourcing views. It rides on your SCE rather than replacing it.

Mirror

The governance your LSAF, Oracle LSH, and Domino users already know. Repository, check-in/out, version history, e-sign, process flows.

Delegate

Execution stays in your SCE. Verixa ingests logs, compare results, and conformance findings rather than re-running them.

Differentiate

The OUT-OF-DATE cascade, enforced segregation of duties, portable evidence, and a resourcing layer no SCE offers.

Walkthrough · 1 of 12
The headline differentiator

The OUT-OF-DATE cascade

How it works
  • A programmer refreshes data or amends a spec on an upstream dataset.
  • Verixa flips every validated downstream output to Out of date, forces re-QC, and writes an audit event for each one.

Why it mattersThis is the silent failure that fails inspections. The production program changes but QC never re-runs theirs. Verixa makes that impossible to miss, automatically.

app.verixa.io
The OUT-OF-DATE cascade
Walkthrough · 2 of 12
Double programming, first class

Independent QC, reconciled in one place

How it works
  • Production and QC are owned by different people. The app blocks anyone from QC-ing their own program.
  • The cockpit shows the PROC COMPARE / diffdf result, the parsed log, and every finding with its root cause.

Why it mattersThe production-to-QC pair is the unit of work, not an afterthought bolted onto a generic task tracker.

app.verixa.io
Independent QC, reconciled in one place
Walkthrough · 3 of 12
21 CFR Part 11, provable

A tamper-evident audit trail you can prove on the spot

How it works
  • Every change is an append-only, hash-chained transaction with who, what, when, and why.
  • One click recomputes the SHA-256 chain. Alter a single historical record and the chain breaks, pointing to the exact event.

Why it mattersAudit prep stops being a fire drill. Export an inspector-ready e-record in one click, filtered to what they asked for.

app.verixa.io
A tamper-evident audit trail you can prove on the spot
app.verixa.io
A tamper-evident audit trail you can prove on the spot
Walkthrough · 4 of 12
Part 11 Subpart C

Electronic signatures bound to the exact version

How it works
  • Sign-off re-authenticates the signer and records a meaning of Authored, Reviewed, QC-Approved, Approved, or Released.
  • The signature is cryptographically bound to the record hash and invalidates the moment the record changes.

Why it mattersEnforced and guided out of the box, not a liberal e-sign that auditors have to take on faith.

app.verixa.io
Electronic signatures bound to the exact version
Walkthrough · 5 of 12
The operational truth

Every program, every status, one board

How it works
  • See production and QC progress as a sortable table or a kanban board.
  • Filter by validation status. Assignments enforce segregation of duties.

Why it mattersThe real state of the study, finally out of a fragile spreadsheet and into a system of record.

app.verixa.io
Every program, every status, one board
Walkthrough · 6 of 12
Familiar on day one

A versioned repository your LSAF users already understand

How it works
  • Check out to lock, edit, then check in with a comment. A new version supersedes and the prior signature invalidates.
  • Version history carries a Signed column. Object-level ACLs control who can read, write, and sign.

Why it mattersAnyone who has used SAS LSAF or Oracle LSH is at home immediately, without the SAS lock-in, the cost, or the dated interface.

app.verixa.io
A versioned repository your LSAF users already understand
Walkthrough · 7 of 12
Reproducibility

How an output was made, on a single coversheet

How it works
  • Open any output to see the source-data snapshot and every program that touched it, each with its version and validation status.

Why it mattersThe auditor-facing artifact that answers how was this produced in seconds, not days.

app.verixa.io
How an output was made, on a single coversheet
Walkthrough · 8 of 12
One record, the whole story

Overview, versions, runs, QC, lineage, history, sign-offs

How it works
  • Everything about a program lives on one record, including its run manifests and its full audit history.

Why it mattersNo more stitching the story together across five disconnected tools.

app.verixa.io
Overview, versions, runs, QC, lineage, history, sign-offs
Walkthrough · 9 of 12
Governance that guides

Process flows that drive the work

How it works
  • Model the program life cycle as a process flow. The live diagram highlights the current step.
  • Auto-Flow instantiates the right flow for each deliverable.

Why it mattersGovernance that guides the work instead of sitting in an SOP binder nobody opens.

app.verixa.io
Process flows that drive the work
Walkthrough · 10 of 12
A layer no SCE has

Capacity planning tied to the deliverable backlog

How it works
  • A demand-versus-supply heatmap shows who is over or under allocated, week by week.
  • Spot the database-lock crunch before it derails the timeline.

Why it mattersThe resourcing view leadership has been running in a separate spreadsheet, finally connected to the work.

app.verixa.io
Capacity planning tied to the deliverable backlog
Walkthrough · 11 of 12
Milestone-anchored delivery

Every milestone, with the critical path

How it works
  • All of a portfolio's milestones on one timeline, with the critical path and a today marker.

Why it mattersDatabase lock is the pivot. See slippage early instead of being surprised by it.

app.verixa.io
Every milestone, with the critical path
Walkthrough · 12 of 12
Leadership view

Submission readiness at a glance

How it works
  • A composite readiness score, QC first-pass rate, utilization, and a rule-based study-health risk engine.

Why it mattersLeadership sees study health and risk without ever asking for a status update.

app.verixa.io
Submission readiness at a glance
Why Verixa

Built for the seam nobody else owns

CapabilitySpreadsheets / JiraSAS LSAF / Oracle LSHDomino SCE QCVerixa
21 CFR Part 11 audit trail (immutable, hash-chained)
Double-programming as the first-class object
Auto re-QC on upstream change (OUT-OF-DATE cascade)
Environment-agnostic (rides on any SCE you use)
Resource and capacity planning built in
Modern, fast, usable UI
Portable, exportable validation evidence
Built for every seat

One system of record, six points of view

Biostatistician

Confirm outputs are SAP-aligned, sign off with confidence, and see where the risk is.

Statistical programmer

A clear queue of production and QC work, with handoffs and version drift surfaced.

QC programmer

Independent double-programming, the compare result, and findings reconciled in one cockpit.

Medical writer

Find exactly which TLFs are FINAL and safe to embed, with version and timestamp.

Project lead / PM

Capacity, milestones, and study-health risk in one place, ready to rebalance.

QA / auditor

A read-only, tamper-evident trail and a one-click inspector export.

Compliance and trust

Regulatory rigor, by construction

The controls auditors look for are inherent in the system, not bolted on after the fact.

21 CFR Part 11

Append-only audit trail, electronic signatures bound to record hashes, access control, and software-enforced segregation of duties.

ALCOA+

Attributable, legible, contemporaneous, original, accurate, and the rest, by construction rather than by policy.

GAMP 5 / CSA

Configuration over customization, designed to be a validatable system with a shipped qualification pack.

Retention and access

25-year retention with WORM storage, legal hold, role-based access, and an inspector-ready archive.

Book a 30-day pilot on one of your studies

See Verixa run your real double-programming, sign-off, and audit flows in weeks, not quarters. No infrastructure to stand up, no migration, no risk to your SCE.

  • We load one of your studies into a private workspace
  • Your team runs production, QC, and sign-off end to end
  • You get an inspector-ready e-record export to keep
  • A readout on time saved and gaps closed
Talk to us · info@the-bdkm.com · BDKM LLC · Back to Life Sciences