Should med tech companies use AI tools for SOP writing​?

Can ChatGPT generate SOPs?

Looking for further shortcuts and cost savings on your eQMS development? The dawn of AI offers an alternative to paying for 'canned procedures'.. You can now just ask AI to write them for you.

It’s true that ChatGPT and similar LLMs are perfect for generating certain kinds of boilerplate content quickly.

They might also be used for editing and improving clarity in technical documentation.

But ChatGPT can’t tell you what your Standard Operating Procedures ‘should be’. In fact, no one can. That's because your SOPs aren’t generic instruction manuals; they're the codified blueprint of how your company specifically operates.

The pitfalls: Why AI can’t be trusted with your SOPs

1. ChatGPT doesn’t know how you actually work

ChatGPT doesn’t understand how your quality system, risk profile, or engineering process actually works. ISO 13485 requires procedures to be established, implemented, and maintained in line with your real operations. Generic AI-generated SOPs can’t meet that bar.

2. Context Matters

AI doesn’t know your company’s structure, roles, product classification, or tools. A ready-made CAPA process may sound impressive - but it could be wildly out of sync with your actual workflows or the quality outcomes that you need to achieve with your available resources.

We’ve said before that ‘over-processing’ is one of the major reasons for audit failures in the medical device sector. In the words of Sean Knights, Director of Operations and Quality at Calla Lilly Clinical Care,

"If your SOPs are outsized compared to the scale of your organisation, auditors may question whether employees are able to perform your process in the way you say they should”

3. Traceability & validation Issues

If your SOPs were drafted by an AI and no human can explain how they were arrived at - will you be able to defend them in an audit? Auditors expect to see version control, rationale for procedural design, and links to training, risk controls, and outputs.

4. Confidentiality Risks

If you’re using public versions of ChatGPT (vs. private/enterprise deployments), you may be exposing sensitive IP or regulatory strategy during prompt submissions. When using AI to work with commercially sensitive information, you should stick to paid-for subscription accounts (with the right settings) so your data is not recycled and shared by the LLM.

5. False Confidence

Just like with off-the-shelf SOP bundles, leaning too heavily on AI-generated documents can give teams a misleading sense of regulatory preparedness. SOPs are not a tickbox exercise - they are instruments of behaviour change. Real compliance requires more than having a document in your repository; it demands implementation, continuous training, version control, and audit-ready traceability.

Without these, AI-generated SOPs risk becoming shelf-ware that look good on paper but fall apart under scrutiny.

Worse, this false assurance can delay real operational change and mask deeper systemic gaps.

Where AI can help with your SOPs

AI tools like ChatGPT can have a role to play in SOP development - but only when used wisely and at the right stage of your quality journey.

Once your SOPs are established and accurately reflect how your company works, AI may be able to help improve their clarity, consistency, and presentation. It can format documents to meet your internal standards, adapt content for different audiences, or assist with summarisation for training and onboarding purposes. AI is also useful for drafting non-critical documentation or as a brainstorming partner in the early planning phases. You can even use it for generating multiple choice questions and answers for your Training Management System.

But these are optimisation tasks, not foundation-building content writing.

Because, when it comes to compliance, your SOPs must be grounded in your business reality - reflecting the real tools, teams, and processes you use every day.

And they need to be built with traceability and validation in mind, as well as the perspectives and priorities of the bodies who will be auditing you.

In fact, when I asked ChatGPT about whether it was a good idea to use its tools to generate procedures - it was quite clear about its own weaknesses.

Why SOPs are more than documents

Instead of relying on AI to shortcut your way to compliance, it’s smarter to work with consultants who understand the regulatory landscape and the realities of your working environment.

A good consultant won’t just help you write SOPs, they’ll guide you through the process of capturing how your organisation actually works. They’ll help you design procedures that are realistic, compliant, and aligned with your available resources, tools, and risk profile.

More importantly, they’ll help you embed these SOPs within a living, breathing electronic quality management system (eQMS) - one that:

• Tracks version history and procedural changes over time
• Records why decisions were made and who made them
• Assigns clear ownership and approval responsibilities
• Establishes robust processes for change control and training

What is the role of AI in building an eQMS?

Beware of eQMS providers that claim to be ‘powered with AI’. The use of AI in regulated industries like med tech is a huge topic of discussion and dispute around the world right now. Regulators in many countries are developing guidance and guardrails. There are many requirements for validating these tools and their outputs if they are integrated into your digital processes.

Having said that, AI tools like ChatGPT can and should be your co-pilot as you figure out how to express and present your SOPs. But they should always be a co-pilot rather than a primary creator.

Make sure you control how your SOPs are documented and followed

In regulated industries like MedTech, it’s not enough to have SOPs. You need to prove that they’re followed, understood, and are subject to continuous improvement. That means building your QMS around traceability, accountability, and control, not just documentation that seems to tick the right boxes.