ISO 27001 CERTIFIED · VALIDATED CLOUD · 21 CFR PART 11 · GAMP 5
Part 11 Compliance

eInfotree Access Desktop

Make your existing Access databases 21 CFR Part 11 compliant.

Database compliance without migration

Access databases hold batch, test and clinical data, yet usually have little to no security. That lets unauthorized users change records. The module adds audit trails, e-signatures and security to the databases you already use.

Benefits

  • Users still open databases with a double-click.
  • No migration: files stay in native Access format.
  • Quick install with no dedicated server.
  • Easy to configure, use and maintain.
  • A validation package is available.

Features

Audit Trail

A secure record of every change.

  • Who and when: User ID, full name, date and time.
  • What changed: Table, field, form, action, old and new values.
  • Why: Configurable reason fields.
  • Access: Logins, logouts, invalid attempts, password changes and lockouts.

Electronic Signatures

Signatures that meet Part 11 rules.

  • Configuration: Require signatures by action type and form.
  • Record: User ID, printed name, date, time and meaning.
  • Meanings: Configurable.
  • Re-signing: Outside a continuous period requires all components.

Security

Access controls you configure.

  • Workgroup: Integrates with and enforces Access workgroup security.
  • Passwords: Enforced length, composition and aging.
  • Lockout: After failed attempts; admins can deactivate accounts and force a reset.
  • Sessions: Automatic time-outs.

eInfotree Access Module Brochure Download

A 21 CFR Part 11 compliance solution for Access databases.

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