New external requirements, a CAPA, a reorganization: cdot captures every change, shows exactly which internal documents are affected and drafts compliant updates.

Your internal documents:
always

What we solve

Policies go out of date the moment something changes.

Your SOPs, policies and work instructions have to reflect two moving targets at once: the way your organization actually works and the external requirements that apply to you.

01/03

Change from every direction

Internally, CAPAs, audit findings, new roles, new systems and reorganizations. Externally, new regulatory requirements, technical standards and authority guidance. Nobody can track all of it by hand.

Dozens of relevant changes every quarter, from outside and inside.

Unclear impact

A single change can affect dozens of SOPs. Which passages, which documents and which downstream work instructions usually lives only in people's heads.

One change, dozens of SOPs touched, and no reliable map of which ones.

Manual, error-prone updates

Gap analyses in spreadsheets, inconsistent documents and outdated versions in circulation. The result: audit findings and wasted expert time.

Outdated versions in use become audit findings.

How it works

From change to compliant SOP in four steps.

cdot handles the tedious part of document maintenance. Your experts make the decisions.

01
Capture change
Internal changes such as CAPAs, deviations, org or process changes are submitted by your teams or come in from your QMS. New external requirements land in the same inbox.
02
Analyze impact
Each change is mapped to the affected passages across all your controlled documents, including indirect dependencies between them.
03
Draft compliant updates
AI proposes redlined edits that stay consistent across documents and are checked against the applicable requirements, with sources cited.
04
Review & publish
Process owners review and approve every change. The full audit trail and traceability are kept automatically.

Why cdot

Never worry about outdated policies again.

Your SOPs and policies always reflect the current state of your organization and of the external requirements that apply, not the last review cycle. Every edit is traceable to the change that triggered it, from CAPA to SOP. And your experts stay in control: cdot prepares, your process owners decide.

Internal changes

CAPAs & deviations
Audit findings
Org changes
Process & system changes

Your controlled documents

SOPs · policies · work instructions

External changes

Regulations
Technical standards
Authority guidance

less time spent on gap analysis

traceable: every change linked to its trigger and approval

faster SOP update cycles

Features

One platform for every change to your controlled documents.

From the first signal to the approved document: everything in one place.

01/04

Every change in one queue

External and internal changes land in one prioritized inbox, so nothing slips through between quality, regulatory affairs and operations.

Internal triggers: CAPAs, deviations, audits, org and process changes
Regulatory monitoring via our partner Codara
Relevance scoring for your organization

Industries

Built for quality teams in regulated industries.

Where policies always have to be right, and quality assurance owns them.

Our focus
Pharma & Life Science
GMP leaves no room for outdated SOPs. cdot keeps SOPs and work instructions aligned with EU-GMP, ICH guidelines and FDA requirements, and with every CAPA and process change in your plant.
- EU-GMP
- Annex 1
- Annex 11
- ICH Q9 / Q10
- GDP
- FDA 21 CFR Part 11
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Industry
Manufacturing
For cosmetics and food manufacturers: keep hygiene, manufacturing and testing instructions aligned with cosmetics GMP, HACCP and IFS/FSSC, as well as with your own continuous improvement.
- ISO 22716
- EU 1223/2009
- HACCP
- IFS / FSSC 22000
- ISO 9001
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