Why Spreadsheet-Based QMS Will Fail Your Next Audit

Let's be honest: most medical device startups begin their quality management journey in Excel. A few spreadsheets for document tracking, a shared folder for SOPs, maybe a Google Sheet for CAPAs. It's free, everyone knows how to use it, and it works — until it doesn't.

The problem isn't that spreadsheets are bad tools. They're great for budgets and project plans. But as a quality management system for a regulated industry? They're a liability waiting to surface at the worst possible moment: during an audit.

The audit trail problem

This is the big one. ISO 13485, 21 CFR Part 820, and EU MDR all require you to demonstrate traceability — who changed what, when, and why. Auditors don't just want to see your current documents. They want to see the history.

Spreadsheets don't have real audit trails. Yes, Google Sheets has version history. But "version history" is not an audit trail. There's no way to lock a version, no electronic signatures, no proof that the person who approved a document actually reviewed the correct revision. An auditor will see right through it.

When an FDA investigator asks "show me the approval history for this SOP," pulling up a Google Sheets revision timeline is going to raise more questions than it answers.

Version control chaos

You've seen this play out. Someone downloads the master CAPA log, makes edits offline, and emails it back. Meanwhile, someone else is editing the live version. Now you have two sources of truth and no way to reconcile them automatically.

Worse, there's no enforced review-and-approve workflow. Documents go from "draft" to "effective" because someone changed a cell value — not because a designated approver reviewed and signed off. Under 21 CFR Part 11, electronic records need proper controls. A cell in column F that says "Approved" doesn't cut it.

No access controls worth mentioning

In a real QMS, you need role-based access. Quality managers approve documents. Engineers can draft but not publish. Read-only access for auditors. Spreadsheets give you "edit" or "view" — that's it. There's no granular permission model, no way to prevent someone from accidentally (or intentionally) modifying a controlled document.

During an audit, you need to demonstrate that your system prevents unauthorized changes. "We trust our team not to edit things they shouldn't" is not a control. It's a hope.

Training records fall apart first

Training management is often the first spreadsheet-based process to collapse. You need to track who was trained on which document, when, and whether the training is still current when a new revision is released. In a spreadsheet, this means manually cross-referencing document versions against training logs. One missed update and you have employees working from obsolete procedures — a common finding in FDA warning letters.

A proper document control system triggers retraining automatically when a document is revised. Spreadsheets require someone to remember. People forget.

The real cost of "free"

The argument for spreadsheets is always cost. They're free. But consider what happens when your audit goes sideways:

• • FDA 483 observations require formal responses and corrective actions
• • Notified body findings can delay your CE marking by months
• • Customer audits that flag QMS deficiencies can kill deals
• • Remediation consulting runs $200–$400/hour

A single audit finding related to document control can cost more to remediate than years of QMS software. The spreadsheet wasn't free — you just deferred the cost.

When to make the switch

If any of these describe your situation, it's time to move off spreadsheets:

• • You're preparing for your first ISO 13485 or FDA audit
• • You have more than 20 controlled documents
• • Multiple people need to review and approve documents
• • You've had a near-miss with an outdated document
• • You're spending hours preparing for audits instead of minutes

The transition doesn't have to be painful. Tools like ArvoDocs are built specifically for small teams that need real document control without enterprise complexity. You can sign up, migrate your documents, and have a working QMS in a day — not a quarter.

Your auditor won't care that you're a startup with limited resources. They care that your quality system works. Spreadsheets will eventually let you down. Better to make the switch on your timeline than on the auditor's.