There is no shortage of regulatory requirements in the manufacturing industry and instrument manufacturers have a long list of raw materials, assemblies, and finished products to manage. Traceability is important for regulatory compliance, in addition to strict quality control processes, audits, and an efficient recall process. Managing product serial numbers in spreadsheets is risky, which is why many instrument manufacturers are turning to today’s more powerful business management solutions.
Customers and distributors expect reliable, detailed product specifications and so do many regulatory agencies. Should there be a breakdown in product quality or you face a widespread product recall, you need to be able to react fast. Notifying customers and locating the recalled items isn’t easy when key data is lost in disparate systems or spreadsheets. Download this eBook, “7 Ways Analysis and Control Instrument Manufacturers Respond to Rapid Change,” to learn how you can streamline regulatory compliance by replacing manual processes with modern business technology.
Today’s business management solutions offer standardization and automated data management features needed by instrument manufacturers. You can use lot and serial number tracking to automate traceability for each item, assembly, or finished product as it enters and leaves your facility. For more complex manufacturing operations, you can manage component-to-parent inheritance and track unique parts or sub-assemblies within finished products. In addition, built-in audit tools, electronic signatures, and document controls protect the integrity of your data, while also satisfying increasingly strict FDA and other regulatory reporting requirements.
Replacing inefficient and often inaccurate manual processes with an integrated business management solution not only saves valuable time when managing data, it streamlines compliance efforts. You can prepare reports quickly and accurately for regulatory reporting or, in the event of a recall, act fast to protect customers and pull recalled products. Swift response can protect your reputation and reduce the costs that often accompany the recall process. Download 7 Ways Analysis and Control Instrument Manufacturers Respond to Rapid Change and contact RKL eSolutions for guidance with replacing legacy systems with the modern business solutions that can modernize regulatory compliance activities and reduce risk.
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