Compliance document management on M‑Files

Ready when the auditor asks

Compliance asks the same of documents whatever the regulation: an approved version, reviewed changes, access for those who need it, a log of what happened, and deletion when the rule says. M‑Files is set up to do all five, for GDPR, for ISO 9001 with VisualQMS and for your own policies.

A quality standard clause by clause in M-Files: the statements of ISO 9001 as a tree with one clause opened to the documents, process activities and CAPA that answer it
The basics

What compliance asks of your documents

Compliance document management is keeping the documents a regulation or a standard requires under control: one approved version, changes that are reviewed and recorded, access limited to the people who need it, a log that shows what happened, and retention that keeps or deletes on time. M‑Files does this with metadata and workflows, so the rules follow a document into every view.

One approved version

Every change becomes a new version, the approved one is what people open, and the earlier ones stay behind it in the history.

Changes that are reviewed

A change goes through review and approval as a workflow, with tasks and deadlines, and moves on when all approvers have responded.

Access for those who need it

Permissions follow what a document is and who it concerns, so a document can inherit the rights of its project or its customer.

A log you can export

The event log records changes, downloads, deletions and each workflow step with the time and the user, and it can be filtered and exported.

Kept and deleted on time

Retention rules archive or delete documents after a set time counted from a date on the document, with a notice or a review first.

Reviewed before it falls due

A review date on a document creates a task before it passes, so a procedure is checked on time.

Controlled documents

From draft to approved to retired

A controlled document is one whose changes are governed. In M‑Files the governing is a workflow, set up in a graphical designer rather than written as code, so the steps match your procedure.

  1. Draft

    The author

    A new version is created and the approved one stays in force. The draft is open to the people working on it and to nobody else until it is approved.

  2. Review and approval

    Reviewers and approvers

    Each gets a task with a deadline and a reminder before it. The event log records every state change with the time and the user, and an approval can carry an electronic signature.

  3. Approved and published

    Everyone with access

    The approved version is what opens. A review date on the document creates a task before it passes, and M‑Files can run your own versioning scheme, such as revision letters.

  4. Retired by rule

    When a document is superseded or its time is up, a retention rule archives or deletes it after the period you set, with a notice or a review first. Deletion first hides the document; permanent destruction is a separate step.

Audit readiness

What you can show an auditor

An audit is a set of questions about documents. These are the answers M‑Files has ready.

The version in force on a date

The version history shows which version applied on any date and what changed between versions.

Who approved it and when

Each approval is a workflow step recorded in the event log with the time and the user, and it can carry an electronic signature as well.

The log, filtered and exported

Changes, downloads and deletions for the period, exported as one file. With M‑Files' advanced logging module, the log also records each time a file is opened.

The requirement and what meets it

In VisualQMS, which runs on M‑Files, each requirement of a standard is linked to the documents, process diagrams and quality activities that meet it, so the auditor's question is answered from the requirement itself.

The M-Files web client with one employee opened to her HR documents beside her metadata card with department, job title and manager
GDPR and personal data

What the system keeps track of for you

  • Data is deleted when its time is up — A deletion rule counts from a date, such as the day an employee left, and deletes the data when the period ends. Before that a notification can go out, or a list can show the deletions coming up.
  • People see what their job needs — HR documents can be open to the employee, their manager and HR, and closed to everyone else. Access follows what a document is and who it concerns, and it can change as the work moves to a new step.
  • A log of who changed what — Every change, download and upload is logged, and so are deletions. When an internal audit or a regulator asks, you filter the log and export it.
  • One search finds everything about a person — Documents about a person are tagged with that person, so one search finds them all when someone asks what you hold about them. Documents export as they are or as PDF, other data as Excel.

See how a deletion rule is set up

Regulations

Set up for the rules you answer to

We set M‑Files up for GDPR, and for quality management with VisualQMS. The controls are the same each time. What changes is which documents they cover, for how long, and who has access.

  • GDPR — Personal data sorted by type, with deletion rules, access and subject access requests.
  • ISO 9001 with VisualQMS — Controlled documents, training, audits and CAPA, with documents tagged to the requirements of the standard.
  • Your own policies — Periods and access set for each type of document, to match the policies you work to.
Next step

Bring the questions your auditors ask

Book a demo and we show a deletion rule, access that follows the document, and the event log. We answer the same working day.

Questions

Questions from auditors and IT

Does M‑Files make us GDPR compliant?
No system does that for you. M‑Files gives you the controls, and how they are configured and used decides whether you meet your obligations. We configure them with you, for GDPR and for the policies you work to.
Where can a deletion rule be set?
On a single document, on a document class, or on metadata such as the employee, counted from a date like the leaving date. A notification can go out before the deletion, or a view can list the deletions coming up. When the period ends the data is deleted automatically.
How is access set, and how do people sign in?
Access is set per document class and on any metadata, such as the customer or employee a document concerns, for people or groups. It can widen or narrow as a workflow reaches a new step. People sign in with the account they already have, through Microsoft Entra ID or your Windows domain, or with an M‑Files account.
What does the event log record?
Changes, downloads, uploads, deletions and workflow state changes. The log can be filtered, searched and exported, and with M‑Files' advanced logging module it also records each time a file is opened.
What does an auditor get to see?
The version in force on a given date, who approved it and when, and the event log for the period as an export. For a standard such as ISO 9001, VisualQMS links each requirement to the documents and activities that meet it. What you keep and for how long are your decisions; M‑Files carries them out.
How is a periodic review handled?
The review date is a field on the document. A workflow creates a task for the owner a set time before the date, with a reminder before the deadline, and the review itself is recorded as a workflow step. A document that is not reviewed in time shows up in a view of overdue reviews.
Is M‑Files itself certified?
M‑Files holds an ISO/IEC 27001 certification that covers M‑Files Cloud, Hubshare and Aino. It acts as a data processor under GDPR and offers a data processing agreement. M‑Files Cloud runs on Microsoft Azure, where your data is encrypted in storage and in transit, and the file encryption keys can be kept in your own Azure Key Vault. Your own certification remains a matter for your certification body.
Can approvals carry an electronic signature?
Approvals inside the company are workflow steps, recorded in the event log with the time and the user, and a signed approval with an electronic signature is added with M‑Files' electronic signatures module. Contracts signed with an outside party use the DocuSign or Adobe Acrobat Sign integration with your own subscription; see contract management.