Your Lab Doesn’t Need a Ransomware Attack to Fail an Audit
Why “Nothing Happened” is the Most Dangerous Assumption in Data Integrity
Let me say something that’s going to make some IT people uncomfortable:
Most laboratories will never experience a dramatic cybersecurity attack!
No masked hackers.
No ransom notes.
No Hollywood chaos.
And that’s exactly why so many labs fail audits.
Because their data doesn’t get destroyed. It gets quietly compromised by normal, boring, everyday failures
For laboratories conforming to ISO/IEC 17025:2017, data integrity failures often surface during audits, and not at the moment systems actually fail.
What Actually Happens in Analytical Labs
Here’s what I have seen, repeatedly:
Servers dying without warning
Hard drives failing mid-run or in the middle of the night
Power outages and lightning strikes damaging hardware.
Corrupted files after a system update
Virus infections that slow systems or edit files
“Temporary” workarounds that eventually become permanent
Manual data restores performed by IT with no regulatory context
There is no crime scene. Or supervillain to blame.
Just a system that no longer tells a defensible story.
The Audit Problem Nobody Sees Coming
The lab keeps operating otherwise normally.
Client samples look fine. QC’s all pass. Clients are happy.
That is until an auditor asks as simple question:
“Walk me through what happened to your data during that outage.”
That’s when the trouble starts.
Because what actually happened is usually something like this:
Data was restored, but no one knows from which version
Audit trails were reset or overwritten (or worse, never existed at all)
Timestamps no longer align with analyst activity
No immutable record exists of the original data state
From a regulatory standpoint, that data is no longer trustworthy, even if it’s scientifically correct.
This is precisely the type of exposure identified during a structured regulatory readiness gap assessment, where data integrity weaknesses often exist long before an auditor forces the issue.
How Regulators Evaluate Data Integrity After a Failure
While ISO/IEC 17025:2017 defines requirements for laboratory competence, impartiality, record control, and technical validity, regulators often evaluate data integrity through a separate lens, commonly described as ALCOA+ principles.
These principles are not a compliance standard. They are a framework used to asses whether data can be trusted.
From that perspective, regulators don’t differentiate between:
Malicious tampering (hacking, malware, ransomeware)
Hardware failures
Well-intentioned IT fixes
If records cannot be shown to be:
Attributable
Legible
Contemporaneous
Original
Accurate
Complete, consistent, enduring, and available
Then their reliability is questionable, regardless of intent.
Accidents don’t receive exemptions. Only evidence carries weight.
Why “We Fixed It” is the Wrong Answer
Now, this is where I've seen labs get blindsided.
Because “fixing” systems often destroys evidence:
Restoring a backup overwrites history
Rebuilding a server erases context
Manual file recovery breaks traceability
Reinstalling software resets logs
While you may have a functioning system, you end up with undefendable data.
Operationally stable. Regulatorily exposed.
The Question Regulators Actually Care About
NOT: “Do you have cybersecurity software?” or “Do you have an IT Team?”
BUT: “Can you prove your data remained intact across failure?”
That requires:
Versioned backups
Immutable recovery points
Preserved audit trails
Documented restore testing
Not as IT features…
But as Quality System Controls.
Where Some Labs Get This Right
A small number of laboratories design their data recovery strategy as part of their quality system, not as an IT afterthought.
They plan for:
Boring Failures
Human Mistakes
Hardware Aging
Power Outages / Power Events
They assume something will go wrong and design their systems so they can prove what didn’t change when it does.
This perspective comes from hands-on experience supporting analytical laboratories before, during, and after audits, not just from theoretical compliance models.
A Practical Note on Data Recovery and Backup for ISO 17025 Labs
If you’re thinking about how your lab would defend data integrity after a system failure, this is the class of solution that supports immutable backups and verifiable recovery.
One example I’ve seen used effectively in regulated laboratory environments is Acronis.
The Bottom Line
Most labs won’t be taken down by ransomware. The digital pirates are not at their door.
These labs will be taken down by:
A failed hard drive
A rushed data restore
A well-meaning IT fix
And the absence of proof
If you can’t reconstruct your data environment exactly as it existed before something went wrong, then your compliance posture is already compromised… you just haven’t been asked to prove it yet.
Auditors don’t wait for drama.
They wait for evidence.
If you’re unsure how defensible your current setup really is, it’s worth reviewing before an audit forces the conversation.
Compliance Note
This article discusses data integrity and risk mitigation concepts and does not constitute regulatory or legal advice. Product references are illustrative and based on observed industry use, not endorsements.