Let’s Talk About the Boring Stuff That Could Kill Your Business – Quality & Security

Let’s be honest—QMS, fraud controls, insider threat detection… not exactly stuff that gets founders leaping out of bed. But you know what’s worse than a dry compliance meeting?

• Watching your research walk out the door with a departing employee.
• Getting sued because someone emailed a product claim to a customer before the regulator signed off.
• Losing a major sales deal because your QMS and security systems don’t talk to each other.

If you’re in a knowledge-intensive industry and chasing investor capital or enterprise contracts, these aren’t just compliance risks. They’re existential threats. Thankfully, you probably already have everything you need to prevent them!

Read on to find out how.

Your QMS Doesn’t Have to Just Cover Compliance—It’s Commercial Defence

Sure, you’ve got ISO 9001, ISO 13485, or FDA 21 CFR 820 in place. You have to. But compliance is the floor, not the ceiling. Today, quality is about more than audits. It’s about trust—with regulators, buyers, and investors. And increasingly, quality failures stem from security failures.

This means your risk and compliance programs can’t live in silos – let me show you what I mean:

Security Failure	Business & Compliance Impact
Employee sends IP to Gmail pre-exit	Trade secrets lost, investor trust damaged
Supplier compromise injects code	Product recall, brand hit
Staff emails HCPs with unapproved claims	Regulatory violation, potential litigation
Ransomware halts diagnostics	Delayed care, reputational damage
Research data shared publicly	IP protection compromised

As you can see from this table, these aren’t just cybersecurity issues. They’re business continuity, liability, and commercialisation risks as well, which are exactly what a well-integrated QMS should be catching.

The 3 SMB Risk Management frameworks you need to protect your business

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Integrate Quality and Security to Create Your Advantage

Most deeptechs are SMBs which run lean. No in-house CISO. No army of compliance officers. But—you do have a quality team and a QMS. That’s your edge. If you can embed security, IP protection, and insider threat controls into your QMS, you gain:

• Operational efficiency—fewer tools and frameworks, less duplication
• Investor readiness—clean audit trails, documented controls and processes that work
• Market trust—quality and compliance proof baked in to win and retain customers

The good news is your business can run lean and stay secure.

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So enough talk, what’s the fix? Here’s how you do it

Step 1: Identify Overlapping Risks

Bring together your Quality, IT, Compliance, and Security folks—yes, even if that’s just two people with five jobs—and map out shared risk areas:

• Trade secret risks: Who has access to research, models, or source code—and what happens when they resign?
• Outbound comms risks: Can someone email a healthcare provider or investor with an unapproved claim?
• Supplier risks: Are third-party vendors accessing your R&D environment or pushing code into your stack?
• Data risks: Are IP files, calibration logs, or clinical datasets being handled securely?

Spoiler alert: the same systems and workflows touch all of these. The only thing that changes is who’s watching and why. We can leverage this!

Step 2: Build Integrated, Actionable Processes

Expand your existing QMS workflows—incident logs, CAPA, document control—to cover your information security and fraud risks, such as:

• Departing employee sends IP to Gmail? Log it as a deviation. Raise a CAPA. Trigger access review. Investigate. Retrain.
• Email flagged with unauthorised claim to an HCP? Route through the same CAPA process as any product defect.
• Security incident in supplier data flow? Link it to your QMS audit trail and generate a risk-rated action plan.

If your business runs on the cloud, you probably already have systems to manage these, even if you’re paying for them but they’re not configured. Let’s make them work harder.

Unlocking New Uses for your SIEM: Beyond Cybersecurity

Step 3: Align Your Systems to Real Business Needs

Think like an SMB: use what you already have. Forget vendor feature lists. Start with those core requirements your business actually needs:

• Secure document management
• Workflow orchestration (escalations, approvals, logging)
• Audit trails that regulators and enterprise buyers can follow
• Real-time alerting for policy violations or unusual activity
• Case management for incidents and corrective actions
• Dashboards and management analytics across all domains

Here are some use cases to demonstrate how all this might work in practice:

• Microsoft Purview + Sentinel: Classify sensitive research data, enforce retention policies, and monitor emails to detect regulatory violations and IP risks.
• GCP Chronicle + Workflows: Detect insider threats, trigger automated reviews, sync results with your QMS and HR systems.
• AWS GuardDuty + Step Functions: Scan S3 buckets for unclassified IP, auto-trigger CAPAs in your QMS.
• Digital QMS platforms: These must integrate with your SIEM, cloud, ERP, HR, and research platforms. No integration = no scale.

The result? One process. One system. Many benefits.

Step 4: Monitor, Automate, and Expand

Use your existing monitoring stack—not just for cyber, but for compliance, fraud, and regulatory use cases:

• Microsoft Purview: Classify IP, research data, or regulated content and flag outbound emails that contain unapproved medical claims.
• Splunk or Elastic: Detect download spikes, file movements, or unusual access patterns.
• SIEM + QMS: Auto-trigger a CAPA or risk log entry when a critical security alert is detected.

Now you’re using the same stack to:

• Prevent insider threats
• Catch regulatory breaches, possibly before they happen
• Monitor fraud risk
• Strengthen IP protection
• Prepare for inspections, audits and regulatory approvals

This is where the ROI multiplies.

The Final Word – Strength and Opportunity

SMBs always run lean. But lean doesn’t mean exposed.
You already have:

• A QMS
• Cloud, email, and monitoring tools
• Data and IP worth protecting

All you need is to connect the dots.
Not with more tools. Not with more people.
With smarter, integrated processes that do more with less.

This isn’t about adding compliance for compliance’s sake. It’s about:

• Avoiding lawsuits and insider breaches
• Scaling your business without scaling your risk
• Impressing investors and enterprise buyers with how secure—and smart—you operate

That’s how you build a credible, defensible, and investment-ready business—without losing your edge.

Further Reading

• Curwell, P. (2025). The 3 SMB Risk Management frameworks you need to protect your business
• Curwell, P. (2025). Unlocking New Uses for your SIEM: Beyond Cybersecurity
• Food & Drug Administration (2024). Quality System (QS) Regulation/Medical Device Current Good Manufacturing Practices (CGMP)
• International Standards Organization (2016). ISO 13485:2016 – Medical devices — Quality management systems. 
• Microsoft (2025). Data classification in Microsoft Purview Data Map. 
• SimplerQMS (2025). CAPA Management in the Medical Device Industry. 

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