Indelio
AI-native quality management · 21 CFR Part 11 / GAMP 5
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Document Control

Controlled documents from draft to obsolete — with signatures that can't be faked.

21 CFR Part 11 · ISO 13485 §4.2.4 (21 CFR Part 820, QMSR)
What it does

Manage your SOPs, work instructions, forms, and specifications through a controlled lifecycle: Draft → In Review → Approved → Effective → Periodic Review → Obsolete. Exactly one version is Effective at a time; superseding a document automatically obsoletes the prior version and flags affected users for retraining.

How Indelio handles it

Every review and approval requires a two-component electronic signature (identity + password, re-verified at the moment of signing). Segregation of duties is structural — the author of a document cannot approve it, and every named reviewer must have signed before approval is possible. An author may sign a review of their own document; only the release step requires a second person. Each signature binds to the document's content hash, so any edit after signing visibly breaks the seal. All of it is recorded on an immutable, hash-chained audit trail enforced in the database.

Key capabilities
  • AI-assisted SOP drafting and redline against the regulations (a human always signs)
  • Controlled PDF export watermarked "Uncontrolled when printed"
  • Revision control with one in-flight revision enforced at the database
  • Automatic periodic-review scheduling and reminders
  • AI-accelerated migration of your legacy document library
The whole quality system shares one audit trail.
Document Control plus thirteen more modules — connected, Part 11, validation included.
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Explore the rest of the suite
🔁Change ControlImpact assessment + approval📣Customer ComplaintsIntake, investigation, MDR decision📈Post-Market SurveillanceTrend detection across complaints & nonconformances🛠️CAPARoot cause → action → effectiveness
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