Mastering Document Control: How MedQdoc guides you from draft to archive

By Therese Albinsson

Senior Quality and Regulatory Advisor, Founder and CEO of MedQdoc

ISO13485:2016
Certified

21 CFR Part 11
Compliant

When it comes to building a compliant Quality Management System (QMS), your document control process is at the heart of it all.

Policies, procedures, work instructions, standard operating procedures (SOPs), and technical documentation all need to be up-to-date, version-controlled, and audit-ready.

But too often, document management systems become a source of frustration:

Endless email threads to get a document review done Multiple versions stored in different folders, no single source of truth Stress before audits trying to prove who approved which version With MedQdoc’s electronic document management system (eQMS), we set out to fix that.

Our platform manages the entire document lifecycle — from the very first draft to final archiving — in a single, validated, ISO 13485- and 21 CFR Part 11-compliant solution.

Step 1: Draft – Where It All Begins?

Every document starts as a Draft — and in MedQdoc, that’s where control begins.

Only the creator can edit a draft, but with one click, you can invite other users as collaborators. Together, you can:

Create and co-author Word, Excel, or PDF-form documents directly in MedQdoc
Use track changes to capture edits for regulatory compliance
Leave comments and reply inline — no messy email chains

Each document is automatically assigned an ID number and starts as Version 1.0, ensuring you are always working with a traceable, audit-ready record.

And because context matters, you can:

Tag your document with predefined categories such as Risk Management File, Technical Documentation, Usability File
Link it to one or more products (perfect for Risk Management Reports, Periodic Safety Update Reports (PSURs))
Reference relevant standards and regulations (ISO 13485, MDR/IVDR, 21 CFR Part 820, ISO 27001)

MDR Article 10 states all these general obligations of medical device manufacturers and more specific the section 9 spells out a clear list of what the quality management system (QMS) shall contain.

Step 2: Review – Get everyone on the same page

When your draft is ready for feedback, send it into Review mode.

Notify reviewers automatically
Collect feedback and comments directly in the system
Track progress and see who has completed their review
Keep everyone on the same version and avoid version chaos

This step helps you comply with document control requirements and speeds up your review cycles dramatically.

Step 3: Approval – Secure, Digital Signatures

Once the document is finalized, MedQdoc ensures approval is fully compliant:

Electronic signatures that meet FDA 21 CFR Part 11 requirements
Time-stamped, user-attributed approvals for a perfect audit trail
Role-based permissions so only authorized users can sign off
Change management
Risk management
Complaint handling and vigilance reporting
Supplier management

This guarantees your team always works from the latest, approved version.

Step 4: Published – Distribute with Confidence

Approved documents are instantly available in Published status:

Users see only the documents relevant to them (role-based access control)
Reading receipts track who has read and acknowledged the content
Dashboards and reports give you real-time insights and make audit preparation easy

This keeps your QMS organized, compliant, and inspection-ready.