Modules · Electronic Records Mgt

Sign it. Seal it.
Prove it.

Electronic Records Mgt is the compliance layer under everything in TLM. Capture decisions with real electronic signatures, protect every record with a tamper-evident audit trail, and route anything for review and e-signed approval — all to 21 CFR Part 11. It’s what turns a custom form, a document, or even a leave request into a record you can stand behind at audit time. Because TLM is two apps on one system, people sign and approve in a browser while your quality team owns the controls.

e-signatures · tamper-evident audit trail · 21 CFR Part 11 · approvals

Reviewing and e-signing a record on a tablet
Part 11 record
✓ e-signed · full audit trail
Who · what · when · why
What Electronic Records Mgt does

The integrity every record needs — signed, sealed, and traceable.

Electronic signatures, done right

Meaning, signer, and timestamp on every signature — so a click is a legally-meaningful sign-off, not just a checkbox.

A tamper-evident audit trail

Every create, edit, and approval is recorded and can’t be quietly changed — the feature auditors ask for first.

21 CFR Part 11 by design

The controls regulated industries need are built in, not bolted on — ready for FDA and notified-body scrutiny.

Approvals around anything

Route any record, form, or request for review and e-signed sign-off — the same approval engine that powers workflows like the Leave Request system.

Secure access and roles

The right people see and sign the right things; everything else is locked down and logged.

The layer under every record

e-signatures and the audit trail apply across your documents, CAPAs, forms, and inspections — one integrity standard, not a separate silo.

The dual-app advantage

One system. Two apps. The right tool for every person.

TLM runs as a deep desktop/network Main App and a modern browser Web App on one shared database. Your quality team owns the Part 11 controls; everyone else just signs and approves.

Main App Depth & control
Quality managers · admins · power users
  • Configure Part 11 controls, signature meanings, and roles
  • Define approval routing and multi-step sign-off workflows
  • Audit-trail and access reporting
  • Set security, permissions, and password policy
  • The complete, tamper-evident record of truth
  • Evidence packages for FDA / notified-body audits
Web App Reach & simplicity
Everyone · approvers · management · remote
  • Apply an electronic signature in a browser, from anywhere
  • Approve and sign off without printing a thing
  • See any record’s full audit trail on screen
  • Live dashboards: awaiting your signature or approval
  • Modern web reports — schedule email alerts, and new ones your account rep can spin up fast

Same data, same system — pick the front door that fits the person.

How a record flows through TLM

Capture it. Comply with it. Find it.

Three pages, one record. Build it once in a custom form and it’s automatically a compliant electronic record — and automatically findable at audit time. No re-keying, no shadow binder.

Not sure which page you need? You probably need all three — they’re the same record at three stages of its life.

The AI advantage · TLM, multiplied by Claude

Ask who signed, and what changed.

Ask Claude to walk a record’s history in plain English — who created it, who reviewed it, who e-signed the approval and when — grounded in the audit trail, with a link straight to the record. The compliance story, told in a sentence instead of a spreadsheet.

See TLM, multiplied by Claude →
One connected system

The integrity layer under everything.

Electronic signatures and the audit trail aren’t a separate module you visit — they run under your documents, CAPAs, audits, inspections, custom forms, and reviews, so every record across TLM carries the same Part-11 integrity, automatically.

See it live

Bring us the sign-off you can’t prove today.

We’ll show you the same approval as a signed, tamper-evident electronic record — with the audit trail an auditor wants — in a 20-minute demo.

Request a Demo →

One of our friendly account reps will be assigned to your account and can walk you through it · No credit card

Book a Demo