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OneXPro Pharma
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Built for regulated industries

Compliant quality records, without the paper chase.

OneXPro digitises the records your quality team signs every day — in pharma, engineering and manufacturing — change controls and controlled Excel workbooks — with electronic signatures, complete audit trails and data integrity designed in for 21 CFR Part 11 and EU GMP Annex 11.

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PF/CC/PRD/26/014Initiation

Revision of SOP for batch record issuance and review

Client: Pfizer · Department: Production

Initiated byProduction · Initiated By14:05 IST
Issued byQuality Assurance · Issued By15:32 IST
Initiating Department HeadProduction · HeadPending
Password re-entered at every signature · meaning, date and time recorded
21 CFR Part 11EU GMP Annex 11GxP (GMP · GLP · GDocP)ISO 9001 quality managementALCOA+ data integrityGAMP 5 risk-based validation

Products

One compliance foundation. A growing suite.

Every OneXPro product is built on the same identity, e-signature and audit-trail engine, so your validation, SOPs and training carry over as you add more.

QMS — Change Control

Your paper change control form, made digital section by section — from initiation and QA issuance through impact assessment, department review, classification, Head QA approval, principal-party notification, implementation and closure.

  • Auto-numbered by client, department and year (e.g. PF/CC/EQA/26/001)
  • Every step signed by the role your form names, in order
  • Configurable flow: who fills each section and signs each box
  • Printable record in your paper layout, with the audit trail appended
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Controlled Spreadsheet Review

Keep using Excel — under control. Upload a workbook, decide who may see, edit, review, approve and sign each worksheet, row, column or cell, publish a controlled version and work it with full traceability.

  • Original frozen on upload with its SHA-256 fingerprint
  • Cell-level permission designer — no macros, no shared passwords
  • Record-by-record review, approval and e-signature
  • Hash-chained, append-only audit trail of every change
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GxP Compliance & Security

Designed around the regulations you are inspected against.

Built for GxP records and ISO 9001 quality systems alike. Compliance is not a module we added later: each control below is enforced on the server, for every user, every time.

21 CFR Part 11 e-signatures

Unique personal logins, the password re-entered at every signature, and the printed name, date, time and meaning bound to the record (§11.50, §11.70, §11.200).

Complete audit trail

Computer-generated, time-stamped and append-only. Every change keeps the old and new value, who made it and when (§11.10(e)) — exportable for inspectors.

ALCOA+ data integrity

Records are attributable, legible, contemporaneous, original and accurate — complete, consistent, enduring and available. Signed means frozen; nothing is ever deleted.

Role-based access

Each person sees and signs only what their role and department allow. Sequencing checks stop steps being signed out of order (§11.10(d), (f), (g)).

Isolated data per company

Every customer gets its own database and its own file storage bucket. Requests are bound to your company by a verified token — never by anything a browser sends.

Validation package

URS, FRS, design specification, IQ/OQ/PQ protocols and a traceability matrix, versioned with the software — a head start for your GAMP 5 computerised system validation.

Security by default

Encryption in transit (HTTPS/HSTS) and at rest, strong password policy, account lockout after 5 failed attempts, temporary passwords replaced at first sign-in.

AI that never signs

Optional AI drafting helps write clear text, refuses to invent document numbers, and always leaves the decision and the signature to a person.

Account trail

Every account created, password reset, lockout and permission change is recorded, so administrator actions are as reviewable as user actions.
See the full Part 11 control map

Getting started

A clear path from paper to validated.

01

Configure

We set up your company, departments, clients, users and designations, and map your form's flow — who fills and who signs each box.

02

Validate

Run IQ/OQ/PQ with our versioned validation package and traceability matrix, against your own SOPs and intended use.

03

Go live

Role-based training for initiators, QA, department heads and administrators — then retire the paper register.

Implementation, validation and training services

See it with your own SOPs.

A 45-minute walkthrough on your own change control or spreadsheet — and an honest answer on fit.

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