The FDA Is Backing Automation. Are You Falling Behind?
Automation is the new best practice and the FDA just confirmed it.
The FDA is no longer just approving products. It is also sending a clear message to quality and regulatory leaders: automated, risk-based validation is not just allowed, it is encouraged.
In a major shift, the FDA is embracing automation within its own internal review processes and signaling that regulated companies should do the same.
A Real Shift. Not Just Talk.
This is not about tech trends or buzzwords. The FDA is actively supporting:
- Risk-based validation based on product impact
- The use of automated tools for validation workflows
- A move away from over-validating low-risk systems
This means regulated organizations have more freedom to modernize their validation processes and still stay compliant. In fact, staying manual may now be the riskier approach.
Why This Matters Right Now
If your calibration program still relies on manual validation, you are spending more time and resources than necessary. You are also increasing the risk of delays, documentation errors, and failed audits.
The FDA’s green light on automation is a chance to:
- Streamline validation timelines
- Focus your quality team on higher value work
- Maintain compliance with less manual overhead
- Get new systems up and running faster
The Opportunity Ahead
This shift is more than a recommendation. It is an open door.
With the FDA modernizing its own processes, it is clear that automation is no longer optional for companies that want to stay efficient, compliant, and competitive.
If you are in a regulated industry, now is the time to look seriously at automated software validation. Because the bar is moving, and those who move with it will win.
Interested in learning more about how to automate your software validation process?
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