Compliance Intelligence
One place where the regulations and your quality system are read together.
Comeply follows the regulations that apply to you and reads them against your own documentation, so you can see where you stand without assembling the picture by hand.
How it works
Follow the regulations, compare them to your QMS, and act on the gaps.
The regulations, guidelines and standards that apply to you, read and kept current as they change.
Each requirement read against your own SOPs and controlled documents, so you can see where you stand.
Gaps shown in one overview and followed as owned actions through to closure.
The modules
Ten modules, one workflow.
Follow
the regulationsMonitoring
Every update from the sources you follow, gathered in one feed.
Daily harvesting from 13 regulatory sources, including EMA, FDA, MHRA, ICH, PMDA, the European Commission and EUR-Lex, wherever the source is publicly available. Collections and live scope rules keep the feed to what applies to you. Paywalled standards, such as ISO, are uploaded by you under your own licence.
Requirement database
Each regulation, broken into the requirements it contains, searchable in one place.
Requirements are pulled out of the source one at a time, each marked with its modal strength (shall, should or may), with the original wording one click away. Search across sources, regions and frameworks in a single query.
CrosswalkBeta
What actually changed between two versions of a regulation.
The current version sits next to the draft or revision (Annex 11, for example), compared clause by clause, with new, changed and removed text marked.
Inspection readinessBeta
What FDA inspection data shows, in trends you can act on.
Trends and insights drawn from FDA inspection data, to help decide where preparation should start.
Compare
against your QMSDocuments
Your QMS, connected and read the way you wrote it.
Connect Veeva Vault, MasterControl or a similar system, or upload SOPs directly. The QMS canvas shows how your documents relate to one another, and Comeply suggests which of your SOPs answers which external requirement.
Conformance grading
Each document graded against the checklist for its type.
Grading runs against checklists built from your own templates, and compares a document version over version, so a reviewer can see whether a revision closed what the last one missed.
Reports
Your SOPs checked against regulation, with the evidence attached.
Each report gives a verdict and a severity for every requirement it checks, backed by verified quotes from your own documents. Affected SOPs and open gaps sit in one overview, ready to review rather than assembled by hand.
Act
close the gapActions and task board
From identified gap to closed gap, in the place it was found.
Findings become owned, evidenced actions with SLAs, approver rules and audit history. They sit on a shared board next to your team's day-to-day work and are followed through to closure.
Operational controlsBeta
The controls your SOPs promise, and the evidence that they operate.
Comeply extracts the controls your procedures commit you to, and gives you one place to log evidence that each of them is operating.
Across everything
Atlas
Ask in plain language and get an answer grounded in your own context.
Plain-language regulatory chat built into the platform, not a general-purpose chatbot. It answers from the monitored sources and your own documents, and every answer carries references you can verify.
On screen
The same workflow, recorded.
Three recordings from the product. Nothing plays until you ask it to.
Follow
The monitoring feed
Captured documents from EudraLex, ICH, FDA, PIC/S and eCFR, each tagged with its region, category, status and publication date.
Follow
One guideline, broken into requirements
Annex 11 read into 90 numbered requirements, grouped by section, each carrying its obligation strength and the original wording it came from.
Act
Gaps as owned actions
Requirement-linked tasks moving across backlog, review, progress and completed, each with an owner and a due date.
What it means for you
Deliver right, with less effort.
Always ready to answer
You know where every gap is, and the evidence behind it, before anyone asks.
The full picture in one overview
Instead of fragments spread across several systems, the whole compliance posture sits in one place.
Your experts' time, back on judgement
Document-by-document checking runs in the background, so specialists spend their hours on the calls only they can make.
Let's talk
