🧭 Course overview
After completing the micro-training you will have a basic understanding of the concept, why document control matters in life-science industries and be able to work with controlled documents in SimplerQMS.
The course contains the following chapters:
Why - the foundation for regulatory compliance
Basics - understand the basic components of Document Management and Control.
How-to - see how you manage documents in SimperQMS
🎓 Learning objective: Get a clear introduction to Document Management and Control - and understand how to work with controlled documents in SimplerQMS.
⏱ Training duration: 10 min.
🎯 Target group: Users with limited knowledge of document management or new to working with documents in SimplerQMS.
1. WHY: Document Management (Read: 3 min)
As a life-science company, there are three key risks you want to avoid:
Regulatory or audit risks
Patient safety hazards
Operational inefficiency
The mitigation of those risks is to keep your documents controlled in a quality management systems (QMS) like SimplerQMS.
1.1 Why document management matters
In the life-science industry, documents are not just files. Regulatory bodies pose a long range of regulatory requirements determine how you manage and control your documents.
Documents can include:
A policy (e.g., Quality Policy)
A procedure (e.g., SOP for training employees)
A work instruction (e.g., cleanroom preparation)
A record (e.g., calibration record as proof of completed activity)
1.2 Regulatory foundation (high level)
Regulations such as:
Require:
Document creation, review and approval
Unique identification (including version) - so evolution of a document is clear. Example: version 1.1.
Document approval - so the right person authorise the document. Example: The QA manager.
Audit trail and traceability - so its possible to backtrack who did what to which detail when!
Training and record keeping - so its possible to prove that employees have read and understood important information.
Change control
Distribution and access control
Archiving and retention
Document control supports compliance — and is part of document management.
2. BASICS: Document Management (Video: 3 min)
2.1 The basic elements
Document Lifecycle:
Traceability & Compliance:
✅ Traceability: Every step is recorded through an Audit Trail, showing who did what and when.
✅ Latest Version: Only the current Effective Version is available for use.
✅ Audit Trail: Updates are tracked through Version History, making it easy to see what changed over time.
These elements work together to ensure that documents are always accurate, controlled, and audit-ready.
3. HOW-TO: Document Management (Video: 5 min)
3.1 Step-by-step guide to do it yourself
By viewing the above video or by following the below steps, you are now able to create controlled document and make them compliant in SimplerQMS.
Step 1: Start in Draft
Create and draft your document before sending for review or approval.
Step 2: Review the document
Send the draft for Review to the appropriate reviewers. Capture feedback and make revisions as needed.
Step 3: Approve the document
Route the revised draft for Approval. Confirm properties (owner, lifecycle, effective date) before approving.
Step 4: Make it Effective
After approval, change the status to Effective so the document can be used organization-wide.
When a Change Request is required
If your QMS requires cross-functional assessment, linked actions, or coordinated releases, manage the template via a Change Request instead.
3.2 Practical tips
💡Clarify roles in the workflow
Ensure that Authors, Reviewers, and Approvers are aware of their role in the document workflow: Do they know what is expected of them and are they the right persons for the task?
💡Keep the Version History clear and useful
Use Version History to clearly describe what changed and where. Keep entries short, specific, and easy to understand.
💡Use Change Control when required
Before making updates, consider whether a Change Control process is needed. For many quality documents (such as SOPs or policies), changes must be assessed for risk, impact, and compliance before they are implemented.
3.3 More detailed information in helpcenter
For additional instructions while operating the system, visit our manual on Quality Documents in our help center.
