eQMS & Stock Control for Regulated Industries

Controlled documents and stock, with every action traceable.

DocuTrace is a web-native quality-management and stock-control platform for pharmacy, wholesale and regulated manufacturing. Create, review and electronically sign controlled documents, track every batch to expiry, and stay inspection-ready — on any device.

21 CFR Part 11EU GMP Annex 11MHRAGPhCMisuse of Drugs Regs 2001
100%Web-native — no file uploads
SHA-256Tamper-evident audit chain
Part 11Compliant e-signatures
Mobile-firstBuilt for the warehouse floor
What DocuTrace does

One platform for documents, quality and stock.

Everything a regulated organisation needs to stay in control — built as a single multi-tenant system, not a stack of disconnected tools.

Document control & compliance

Web-native authoring

Create and edit controlled documents entirely in the browser with a rich editor and reusable content variables — no Word files, no PDFs to manage.

Version control & history

Every revision is captured with a full version trail and a mandatory change summary at publish — see exactly what changed, when and by whom.

Approval workflow

Documents move Draft → QA Review → Responsible-Person approval → Published, with the right people gated at each stage.

21 CFR Part 11 e-signatures

Password re-authentication, a recorded meaning of signing, IP/device capture and a SHA-256 hash chain make every signature tamper-evident.

Segregation of duties

The same person can never sign two conflicting control gates — enforced in code, a deal-breaker requirement for life-sciences.

Re-acknowledgement on republish

When a document is republished, affected staff are automatically asked to re-read and re-acknowledge — with RP/QA summaries.

Complete audit log

Every action across the platform is recorded and searchable — a continuous, inspection-ready history.

Paperless auditor access

Invite an external auditor by magic link — an IP-bound, time-limited dashboard with no account to manage.

Inspector Pack PDF

Export a single, self-verifying bundle that proves a document or batch life-cycle is fully signed and tamper-evident.

Quality System packs

Install a complete set of SOPs and policies into a company in one click — a ready-made quality system to build on.

Training & competency

Assign documents and courses, track who has read what, and schedule automatic annual refreshers.

Branded PDF export

Generate watermarked PDFs (Draft / Confidential / Superseded) with a consistent, branded layout.

Stock & controlled drugs

Stock control

Track products, locations, classifications and batches with full quantity-on-hand visibility across the organisation.

FEFO picking

First-Expire-First-Out picking is enforced automatically, with per-company configuration for shelf-life rules.

Receive, pick, dispense, destroy

Complete movement workflows for every stage of a batch’s life, each recorded against the audit chain.

Controlled Drugs register

A dedicated CD register meeting Misuse of Drugs Regulations 2001 — with the pharmacist role and full denaturing records.

Two-witness destruction

CD destruction requires a pharmacist plus an independent witness, both electronically signing the same event.

Multi-site segregation

Keep each site’s stock private and assignable — a user at one warehouse need never see another’s.

Stock take & variance

Run cycle counts or full physical counts and generate clear variance reports against system quantities.

Expiry & low-stock alerts

Automatic warnings for batches nearing expiry and lines below their minimum threshold — in-app and by email.

Batch traceability

Follow any batch end-to-end — receive → pick → dispense — every step signed and tamper-evident.

Organisation & operations

Positions & org chart

Model your reporting hierarchy with positions and managers, and view it as an interactive org chart.

Warehouse zones & map

Define zones and lay out a grid map of your warehouse, with live on-hand totals per zone and location.

Equipment & calibration

Keep an equipment register with calibration certificates, traffic-light due dates and dashboard alerts.

Customer & supplier registers

Maintain customers and suppliers with WDA(H)/GDP fields, certificate uploads and audit-due tracking.

Compliance score

A live dashboard score shows how compliant each company is at a glance, with the drivers behind it.

MHRA recall alerts

Pull MHRA drug and device alerts straight into the dashboard so recalls never slip past.

Multi-tenant & RBAC

Run many companies on one platform with role-based access for admins, RPs, QA, pharmacists and staff.

Notifications

Email and in-app notifications keep the right people informed — approvals, acknowledgements, expiries and more.

Mobile-first by design

Designed for tablets and phones first — the people on the floor and beside the CD safe work on the device in their hand.

Built to pass inspection — not just store files.

DocuTrace bakes regulatory expectations into the platform itself: tamper-evident e-signatures, segregation of duties, complete audit trails and exportable evidence packs. When an inspector arrives, the proof is one click away.

FDA 21 CFR Part 11 EU GMP Annex 11 MHRA WDA(H) / GDP GPhC Community Pharmacy MDR Misuse of Drugs 2001
How it works

From blank page to audit-ready — in four steps.

Create

Author a controlled document in the browser, or receive a batch into stock.

Review & e-sign

QA and the Responsible Person review and electronically sign — password-verified and hash-chained.

Publish & acknowledge

Publish to the right people, who read and acknowledge; republish triggers re-acknowledgement.

Stay audit-ready

Every action is logged. Hand an inspector a magic link or export a self-verifying evidence pack.

Take control of your documents and stock.

See how DocuTrace keeps your quality system and your stock fully traceable — and ready for inspection at any moment.