Introduction
Medical device manufacturer Spectrum Solutions developed the first saliva-based COVID-19 test to receive Emergency Use Authorization from the FDA. Spectrum has over 200 employees at their production facility maintained by a team of 10 technicians and engineers. The FDA audits companies like Spectrum to ensure compliance with its stringent 21 CFR regulations. A failed audit can shut down production with major financial consequences.
The Challenge
The quality and manufacturing teams at Spectrum Solutions performed an internal audit of their paper and Excel-based maintenance system to evaluate its ability to meet regulatory requirements.
They found it was prone to error, wouldn’t be able to scale as the company grew, and made finding documentation at audit time stressful and time-consuming. They needed a better system to take on the challenges and growth they knew were coming in the future.
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A documentation function that automated as much information as possible to reduce errors.
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Flexibility and customization that facilitated the growth of their company and maintenance team.
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Easy and centralized access to the information they needed during FDA audits.
The Solution
Spectrum found that Limble could support all of their maintenance and calibration needs which would streamline the team’s day-to-day activities. Their data would be easy to update and access, making every audit less stressful than the last. And its automated documentation and user-friendly logs meant Spectrum would be able to provide auditors an always-accurate single source of truth.
Finally, because Limble allows for procedures to be clearly defined, it helps onboard new employees without compromising documentation quality. They knew Limble could support all the functions they needed, while enabling the growth they knew was coming.
The Result
After switching to Limble, Spectrum Solutions was prepared for their next audit. The FDA auditor was quickly satisfied with Spectrum’s maintenance and calibration systems. This was attributed to easily being able to produce their records and upcoming schedules—all organized beautifully in Limble. This included over 5000 completed tasks since implementation, all of which were completely searchable.
Limble has allowed them to scale-up their employee count. Spectrum went from 6 Limble users to 10, and it took minimal training to get their employees up to speed on how to effectively use their CMMS.
“The auditors were satisfied very, very quickly.”
400
Assets to Maintain
96%
Work Orders Completed On Time
3
Days to Pass Their FDA Audit