We all know the critical role compliance and data integrity play in life sciences manufacturing.
Regulatory bodies, like the FDA, aren’t just watching…
They’re actively looking for gaps in compliance.
Auditors are trained to find red flags, and sometimes, they’re just waiting for a reason to dig deeper.
When so much is on the line, why give them a chance?
One of the main reasons companies get flagged in audits is due to incomplete, inaccurate, or inconsistent data in air quality monitoring logs.
When records are manually managed or rely on multiple touchpoints, errors multiply, opening doors for auditors to scrutinize every step.
So, how can you close these gaps?
You move from reactive compliance to proactive assurance.
By implementing Digital Air’s audit log solution within your quality management system, you’re safeguarding against human error and data gaps that can trigger costly audits.
Which gives you control over data integrity while minimizing the risk of an audit.
With our 21 CFR Part 11 Compliant Digital Solution, you gain:
Automated Data Capture – Say goodbye to manual entry errors and missed entries because every data point is automatically collected from your air particle counters
Real-time Compliance Tracking – Instantly identify and address any out-of-specification readings before they become audit risks.
Enhanced Data Integrity – Ensure every data point is accurate, complete, and secure from entry to archive.
Reduced Risk of Human Error – By removing all the manual steps, you remove the largest source of data inconsistencies.
And you don’t need to overhaul your entire system or your SOPs.
Whether you’re using Metone, Lighthouse, or Climet air particle counters, our 100% 21 CFR Part 11 Compliant end-to-end digital workflow is designed to integrate seamlessly with your existing equipment…
Providing a safety net against the many errors that cause most FDA audits.
If you’re tired of constantly worrying about what might be going wrong on your manufacturing floor and want to eliminate all the unnecessary risk…
Our Savings and ROI Calculator is based on industry and customer data and shows exactly how much your operation can save—just by reducing human errors alone.
Our current customers have cut their costs associated with FDA audits in half.
This includes one of the five largest pharmaceutical companies globally.
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