Last Updated on October 24, 2025 by Hafsa J.

Why Document Control Is the Backbone of ISO 22716 Compliance

If you’ve ever had three different versions of the same SOP floating around the production floor, you already know the chaos poor document control creates.
In my experience helping cosmetic manufacturers implement ISO 22716, one pattern always shows up — non-conformities rarely come from a bad process, but from badly managed documents.

ISO 22716 expects you to have controlled, traceable, and approved documentation. That means no mystery revisions, no missing signatures, and no “unofficial” edits.
The easiest way to get there? Move to a reliable electronic document-control system (EDCS).

This article walks you through what that looks like in practice — how to set it up, what features matter most, and how to avoid common pitfalls I see during audits. By the end, you’ll understand how the right system can turn paperwork stress into compliance confidence.

Understanding Document Control Under ISO 22716

Document control isn’t about storing files neatly — it’s about proving control.

ISO 22716 requires you to show that every SOP, form, and record:

• Has been reviewed and approved before use
• Is accessible only to authorized users
• Is kept up-to-date and version-controlled
• Is archived properly when obsolete

Here’s what I’ve noticed: many companies use shared drives and think that’s “electronic control.” It’s not. Without version tracking, access logs, and approval workflow, you’re just saving files in digital chaos.

Pro tip: Think of your document system as your organization’s memory. If it’s fragmented or outdated, your team can’t make consistent decisions — and that’s where compliance slips.

Common mistake: Letting everyone have edit rights. When that happens, you end up with multiple “final” versions and no trace of who changed what.

Key Functions of an Electronic Document-Control System

Let’s break down the essential features your EDCS must have to truly support ISO 22716 compliance.

1. Document Creation & Approval Workflow

Your system should route new or revised documents automatically for review and approval.
Each stage — author, reviewer, QA approver — should leave a traceable electronic signature.

Pro tip: QA should always have final approval authority. That signature means the content is validated for GMP use.

2. Version Control & Revision Tracking

Every change should generate a new version automatically. You should be able to see who changed what and when.

Common pitfall: Keeping editable Word files as your master copies. Once a document is approved, lock it as a non-editable PDF or restricted format. That’s what auditors look for.

3. Access Management & Security

A good system lets you control who can view, edit, or approve each document.
Backups, encryption, and audit trails aren’t just IT concerns — they’re compliance requirements.

Pro tip: Keep access simple but secure. Overcomplicated permissions only frustrate users and lead to workarounds.

4. Distribution & Acknowledgment

When a document is updated, your system should automatically notify affected employees and track their acknowledgment.
That’s how you prove staff are working with current procedures.

Example: A cosmetic plant I worked with used to circulate SOPs via email. After switching to automated notifications and read-receipts, their training compliance jumped to 98 %.

5. Archiving & Retention

Old versions must be archived, not deleted. ISO 22716 expects traceability — auditors may ask to see the last approved version.
Define how long you’ll keep documents and how you’ll dispose of them securely.

Pro tip: Align your document retention period with your batch record retention — it keeps everything consistent during product recalls or investigations.

Building or Choosing the Right System for ISO 22716

You don’t need a huge software suite to be compliant — but you do need a system that fits your process.

Here’s what to consider:

• Cloud vs. on-premise: Cloud systems make remote access and backup easier, but confirm data security and location.
• Integration: Ideally, link your document control to CAPA, training, or batch-record modules.
• Audit trails: Make sure every approval and revision is timestamped and uneditable.
• Ease of use: If your operators can’t use it confidently, the system will fail in practice.

Pro tip: Start small. Digitize your most frequently changed SOPs first, then expand.
Example: One mid-size skincare company I supported reduced SOP-review time from two weeks to three days by automating approvals in their EDCS.

How Electronic Document Control Strengthens GMP Compliance

Here’s what happens once you move to a well-designed electronic system:

• You always know which version is in use.
• Auditors can trace document history instantly.
• Staff can access approved SOPs on demand.
• QA receives alerts before reviews or expirations.

That level of control makes audits smoother and eliminates one of the most common findings: “uncontrolled documents in use.”

Pro tip: Use your EDCS data to spot trends — if one SOP keeps changing, it might signal an unstable process that needs improvement.

Common mistake: Investing in software but skipping training. Technology only works when people understand how to use it.

Example: ISO 22716 Electronic Document-Control Workflow

Here’s what a clean, compliant workflow looks like:

Step	Responsible	Action	System Feature
1	Author	Drafts SOP	Version 0.1 created
2	Reviewer	Reviews & comments	Comment tracking
3	QA	Approves	E-signature captured
4	System	Publishes & notifies users	Automated alerts
5	Operators	Acknowledge reading	Read-receipt logged
6	QA	Archives superseded version	Audit-trail entry created

Pro tip: Don’t overcomplicate the process. A simple, consistent workflow beats a custom one that confuses your team.

Training & Change Management

Even the best system fails if your people don’t trust or understand it.
That’s why training is critical during implementation.

Here’s what works:

• Provide short, role-specific sessions for authors, reviewers, and operators.
• Link document updates to staff training records.
• Encourage feedback to refine your workflow.

Pro tip: Pair each new SOP release with a quick e-learning or short video tutorial.
Example: One cosmetics lab added 10-minute micro-trainings to each new SOP in their EDCS. It made audit evidence effortless — training and acknowledgment in one click.

FAQs: Electronic Document-Control Systems & ISO 22716

Q1. Do we need an electronic system to comply with ISO 22716?
No — paper can still work. But electronic control makes compliance easier, faster, and more traceable.

Q2. Are electronic signatures accepted during audits?
Yes, as long as they’re validated, secure, and uniquely assigned to each user.

Q3. How long should we retain documents?
Keep them for at least the same period as product batch records — typically five years or longer, depending on local regulations.

Simplify Compliance with Smart Document Control

I’ve seen this transformation over and over again — once a company shifts to an electronic system, everything becomes easier: training, version control, approvals, even audits.
ISO 22716 compliance isn’t about paperwork — it’s about proof of control, and electronic systems give you exactly that.

If you’re still managing SOPs through emails and printed binders, now’s the time to upgrade.
You’ll spend less time chasing signatures and more time improving your processes.

Ready to get started?
Download our ISO 22716 Electronic Document-Control System Checklist and start mapping your transition today.