Document Control

SOPs · Work Instructions · Records · Forms

The right version, in the right hands, every time. Replace shared drives and redline emails with controlled documents that route themselves, train your team automatically, and survive an inspection on the first pass.

One source of truth

Every SOP, work instruction, form, and record lives in one place — versioned, searchable, and effective on the date that matters.

Inspection-ready by default

Time-stamped audit trail, 21 CFR Part 11 e-signatures, and Annex 11–aligned records. Pull a complete history in seconds.

AI that reads context

Kintavo AI drafts change summaries, flags conflicting SOPs, and suggests reviewers based on document scope and history.

Versioning

A complete history. Without the spreadsheet.

Every revision is a first-class object: who changed what, when, why, and what it superseded. Roll back, branch, or compare any two versions side-by-side.

Visual diff between any two versions
AI-drafted change summary on every revision
Effective dates, not just approval dates
Periodic review reminders, automated
SOP-211 · Aseptic Fill Version History
v3.2
Tightened bioburden limits 10 → 5 CFU/m³
EFFECTIVE · 2024-09-12
J. Park
v3.1
Added vendor-042 fill needle to qualified list
EFFECTIVE · 2024-06-04
M. Chen
v3.0
Re-issue · Annex 1 alignment
EFFECTIVE · 2024-02-18
R. Singh
v2.4
Updated environmental monitoring frequency
SUPERSEDED · 2023-11-02
A. Costa
SOP-211 · v3.2 published
14:02 · J. Park
14 users assigned · Aseptic team
Auto-routed by role + scope
12-question competency check
AI-generated from change diff
100% trained · 4 days
Locked from production until complete
Training-on-change

The document approves. The training assigns itself.

When a controlled document is revised, Kintavo identifies who needs to know, generates a competency check from the change diff, and locks affected work until users are signed off.

Role + scope-based assignment
Competency questions written from the diff
Read-and-understood with 21 CFR Part 11 e-sig
Untrained users blocked from affected workflows
Document lifecycle

Every document. Every step. One system.

From the first draft to retirement, Kintavo handles the routing, signatures, dates, and downstream effects so your team can focus on the content.

STEP 01

Author

Draft from a template, lift content from a prior version, or import an existing PDF.

STEP 02

Review

Routed to reviewers by scope. Comments resolve inline. AI flags conflicts with active SOPs.

STEP 03

Approve

Multi-stage approval with 21 CFR Part 11 e-signatures and reason-for-change capture.

STEP 04

Effective

Goes live on its effective date — not before. Training and dependents update automatically.

STEP 05

Periodic review

Reminders fire on schedule. Retirement, re-issue, or no-change attestation captured for audit.

SOP-211 · v3.2 published
14:02 · J. Park
14 users assigned · Aseptic team
Auto-routed by role + scope
12-question competency check
AI-generated from change diff
100% trained · 4 days
Locked from production until complete
Training-on-change

The document approves. The training assigns itself.

When a controlled document is revised, Kintavo identifies who needs to know, generates a competency check from the change diff, and locks affected work until users are signed off.

Role + scope-based assignment
Competency questions written from the diff
Read-and-understood with 21 CFR Part 11 e-sig
Untrained users blocked from affected workflows
Connected modules

Documents don't live alone.

Every document is automatically linked to the training, CAPAs, deviations, and audit findings that touch it. Change one, the others know.

Training
CAPA
Deviations
Audits
Risk
Suppliers

Ready to see the full platform working for your organization?

Book a personalized demo. We'll show you Kintavo configured for your regulatory environment and your specific workflows — not a generic product tour.

FAQ Questions & Answers

Q: How does version control work when a document is revised?
A: A new draft is created while the current approved version stays active. Once the new version is approved, it automatically becomes the active version and all previous versions are locked from use system-wide.

Q: Can we migrate our existing document library?
A: Yes. Data migration support is included in implementation. Your existing documents are imported, organized, and transitioned into the controlled repository with appropriate version history.

Q: What document types can Kintavo control?
A: Any type — SOPs, work instructions, policies, forms, labels, specifications, batch records, validation protocols, and more.

Q: Is the system validated for 21 CFR Part 11?
A: Yes. IQ/OQ/PQ validation documentation is included in every implementation.

Your documents are living in places they were never designed to be.

SharePoint was built for collaboration, not compliance. Shared drives have no version enforcement. Email approval chains leave no audit trail. When an inspector asks to see every version of a critical SOP — with every approval, every training acknowledgment, and every change justification — most quality teams spend days reconstructing what should take seconds.

Kintavo Document Control gives you a single controlled environment for every SOP, policy, form, and record. Version control that enforces itself. Approvals that cannot be skipped. Training that triggers automatically on every change.