Using Technology to Streamline the Regulatory Compliance Process

In the days before tax preparation software became commonplace, the difficulty of completing an income tax return timely and accurately without the help of a professional was an arduous task. Carefully reading complex instructions, triple-checking math and possibly even sitting on hold for several hours to get a question answered by the IRS were a few of the potential tasks. The introduction of affordable user-friendly software has taken this mandatory requirement and simplified it for a countless number of people.

For suppliers in the medical device and military/aerospace industries complying with government regulations is a prerequisite for doing business. Like income tax preparation, the landscape is often a difficult one to navigate fraught with numerous challenges that have potentially disastrous results if not completed correctly. The advent of software aids in simplifying the process.

A manufacturing execution system (MES) is a control system for managing and monitoring work-in-process on a factory floor. It keeps track of all manufacturing information in real time, receiving up-to-the-minute data from robots, machine monitors, and employees.

A recent article Manufacturing Medical Devices: Using MES to Make Compliance Easier appeared in the trade publication Medical Design Technology.  The article details how the system helps with simplifying the compliance process and keeping operations running in an efficient manner.

To that end, Sparton recently implemented this type of software in its own facilities. One of the key drivers of this initiative was the MES’s ability to provide complete traceability through electronic Device History Records (eDHRs) down to the component level and e-signatures to aid in compliance with FDA regulations. The advanced reporting system provides customers with a large degree of manufacturing insight based on real-time data. It also aids ITAR compliance by delivering the highest level of security.

Similar to the tax preparation days of the past, the installation of an MES has aided Sparton in distilling down a once complicated process into a manageable way to traverse the difficult waters of the regulatory environment.

“It used to take our quality engineers up to four hours to prepare for a meeting. That information is now available at the push of a button,” said Ken McIntosh, Business Systems Analyst for Sparton.

Have an example of how a software implementation has aided your business? Like to discuss some of your pain points with regulatory compliance? Leave a comment in the section below.

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Sparton MES Implementation Case Study

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Medtech Quality and Compliance whitepaper


Navigating the Medical Regulatory Landscape White paper

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