Lab software vendors often market their platforms as “Part 11 compliant,” but those claims rarely tell the full story. “Honestly, what I see a lot of is people just trusting that. . .any software that they’re using is good instead of actually verifying it,” says Brenda Shalloo, an ISO 17025 assessor who has consulted for both EPA and FDA labs.
The reality: CFR 21 Part 11 was not designed to be fully satisfied by software. No program can bring a lab into full compliance with Part 11 on its own because compliant processes are needed as well. Lab managers must take responsibility for validating their systems, documenting compliance, and applying risk-based oversight to fill the gaps that software leaves open.
Why no lab software is fully compliant
FDA Part 11 mandates both technical and procedural controls. This is why “lab software compliance” may be advertised in marketing material, but it’s not much more than a buzzword. Software can implement the technical side—things like audit trails, restricted access, and time-stamped records. But it cannot enforce the procedural side, such as staff training, intent verification, and organizational policies. For example, §11.10(j) requires policies for e-signatures. Software can log a signature, but it cannot necessarily confirm the signer’s true identity or intent. That’s where procedural controls tailored for the lab would come in.
Shalloo notes that many labs overlook this nuance. “Even if you're not the one collecting the electronic signature. . .you still have to verify and validate that they're following Part 11 before you put it into use,” she explains.
Finally, even when validation is conducted, issues still surface. Validation scripts often uncover errors, meaning even “validated” systems may still present edge cases or configuration gaps.
For lab managers evaluating software options, there are ways to maximize technical compliance controls by making an informed purchasing decision.
How lab managers should approach implementing compliant software
First, select software designed for your lab’s niche. A LIMS for a research lab may look similar on the surface to one used in a clinical setting—they’re both centered around sample tracking—but the underlying features differ. A mismatched system can leave serious compliance gaps.
Additionally, Shalloo stresses that every lab manager must treat software like equipment. “Any software that enters your lab still has to be verified and validated prior to being implemented. So, you need to beta test it out, ask appropriate questions, and document the answers,” she says.
That documentation should be thorough and audit-ready. Record and securely back up all correspondence related to validation, including:
- Email threads with vendors
- Testing documents and results
- Screenshots illustrating compliance features working as intended
Finally, when gaps emerge—as they always do—procedural controls are your safety net. For instance, if your system cannot enforce multi-factor authentication, you may require manual identity checks or layered sign-offs for high-risk workflows. “The higher the risk, the more attention that it needs,” Shalloo notes, adding that labs should consider secondary or tertiary sign-offs for critical analyses. Identifying these gaps during the purchasing process will be very helpful in determining which software best fits your lab’s SOPs.
Possible pitfalls with lab software
Even the most careful lab managers can fall into traps:
- Using AI features without auditing them. Lab software vendors are increasingly integrating AI features into their offerings. But as Shalloo warns: “Is that AI bot sharing that data? Because now we’ve got a huge privacy issue.” Many of these features work by sending the data you input to datacenters owned by providers such as OpenAI or Microsoft, which may not have data security measures in place that are compliant with lab regulations.
- Blindly trusting “Part 11 compliant” labels. These are largely marketing terms, not guarantees.
- Copying competitors’ systems. Just because another lab uses a system doesn’t mean it fits your workflows or risk profile.
Keeping humans in the loop
While software and AI tools can streamline workflows and reduce manual burden, they cannot replace human oversight when it comes to compliance. Shalloo warns that reliance on automation without verification is risky: “It’s great, but it’s also not 100 percent reliable and that needs to be taken into consideration.”
Advanced Lab Management Certificate
The Advanced Lab Management certificate is more than training—it’s a professional advantage.
Gain critical skills and IACET-approved CEUs that make a measurable difference.
Ultimately, AI and automated features should assist, not replace, qualified personnel. Human review ensures that compliance requirements—such as confirming e-signatures, validating unusual results, or assessing recall decisions—are met with sound judgment. In practice, that means labs should embed checkpoints where humans must verify or approve critical steps before results are finalized.
Key takeaways
Part 11 compliance isn’t something you can buy—it’s something you prove through effective technical and procedural controls.
For lab managers, that means treating software like any other critical piece of equipment: validate it, document it, and supplement it with procedural controls where gaps exist. The FDA doesn’t expect perfection, but it does expect diligence, risk-based thinking, and proof that your lab is taking compliance seriously.
