Going into 2025, life science manufacturers are still relying on paper air particle paper print outs for their results.
But that’s not even the worst part…
That’s actually just the first step of getting quality control data into a centralized database.
After collecting the printout, a lab tech has to hand copy the results on a sheet of paper.
Then another lab tech enters the data into a database only to have another lab tech review the entry to avoid human error.
Even though the life sciences industry is still relying on pen and paper methods, they aren’t unwilling to adapt and modernize aspects of their operation.
After talking with some of the largest pharmaceutical companies we’ve found that they are quite eager to digitize, but just haven’t found the right solution yet.
The challenge lies in navigating a unique set of obstacles that have slowed process digitization in pharmaceutical manufacturing.
Most notably: ensuring compliance with strict regulatory standards, minimizing production line downtime, and implementing a seamless, paperless data collection process that integrates with existing LIMS systems without disrupting validated workflows.
Because any major change to their SOPs could require a thorough and costly process involving revalidation of affected processes, potential regulatory submissions, and additional audits.
Depending on the impact of the changes, manufacturers may need to undergo inspections or seek recertification to demonstrate continued compliance with regulatory standards and Good Manufacturing Practices (GMPs).
Up until a few years ago, there was no solution that allowed these manufacturing operations to digitize their air particle counters without disrupting their SOPs.
Well that was until we partnered with Merck and eliminated paper printouts from hundreds of their air particle counters in one of their US locations.
Our Digital Air automated collection and eliminated the lab techs from the data collection
process.
Which not only eliminates wasted countless man hours, but it also gets rid of the unnecessary risk that is associated with the pen and paper data collection process.
And generates detailed audit logs that help keep our customers out of trouble when a FDA audit rolls around.
We know that every manufacturer has a variety of QA instruments from different manufacturers…
We’ve enabled our cloud-based solution to work regardless of the make, model or manufacturer of your air particle counter.
Whether you have Met One, Climet, Lighthouse, Lasair or a combination of many different brands…
We’ve got you covered.
If you’d like our solution in action and see step by step how it works…
Where you can remotely take air particle samples…
See our automated data collection and the detail that each sample record has…
And view the audit log that keeps track of every action taken on our platform and on the air particle counters…
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