{"id":29328,"date":"2025-04-02T12:13:26","date_gmt":"2025-04-02T18:13:26","guid":{"rendered":"https:\/\/limblecmms.com\/?post_type=customer-story&p=29328"},"modified":"2025-07-07T11:23:56","modified_gmt":"2025-07-07T17:23:56","slug":"spectrum-solutions","status":"publish","type":"customer-story","link":"https:\/\/limblecmms.com\/customer-story\/spectrum-solutions\/","title":{"rendered":"Spectrum Solutions"},"content":{"rendered":"\n
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Introduction<\/h2>\n\n\n\n

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.<\/p>\n<\/div><\/div>\n\n\n\n

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The Challenge<\/h2>\n\n\n\n

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.<\/p>\n\n\n\n

They found it was prone to error, wouldn\u2019t 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.<\/p>\n\n\n\n

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  • \n \"Icon\"\n A documentation function that automated as much information as possible to reduce errors.<\/span>\n <\/li>\n
  • \n \"Icon\"\n Flexibility and customization that facilitated the growth of their company and maintenance team.<\/span>\n <\/li>\n
  • \n \"Icon\"\n Easy and centralized access to the information they needed during FDA audits.<\/span>\n <\/li>\n <\/ul>\n <\/div>\n <\/div>\n\n