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As part of a highly regulated space, companies in the biotech industry are subject to strict guidelines and oversight. This, in combination with the mounting pressure from consumers to bring new products to market, leaves little room for mistakes....
As more companies move their processes into the digital space, new risks concerning the security of electronic records surface. In March of 1997, the United States Federal Food and Drug Administration (FDA) created CFR Part 11 to combat those...
Tags: FDA Compliant Document Control Software, Compliance, fda guidelines, fda cfr part 11
If you’re a packaging or manufacturing professional, you’ve likely experienced the frustration of spending precious time tracking down product/packaging specification data. The manual nature of managing specifications using spreadsheets, shared...
Tags: specification management, Spec Management, ISO 9001, Compliance
Meeting the ISO/IEC 17025:2017 compliance standards is essential for testing laboratories. Not only does this regulation dictate lab competency, but it also helps demonstrate that your laboratory is performing at par with your internationally...
Tags: Compliance, laboratory industry, iso 17025, ied 17025
No matter the size of the company, food and beverage manufacturers should take employee training seriously. Not only does effective training help you create a quality product, but it also helps keep employees safe on the job, increase employee...
Tags: training management system, Compliance, food and beverage industry, employee training
Pharmaceutical companies are hit year after year with strict regulations and shifting expectations from government organizations. In fact, the number of warning letters administered during failed FDA audits has steadily increased over the last few...
Tags: pharmaceutical, pharmaceutical industry document control, Compliance, regulatory, regulatory compliance
Is your company fully prepared to handle a compliance crisis? Effectively managing this process is no easy task, especially if you’re part of the highly regulated pharmaceutical industry. To make this process less daunting, it’s important to plan...
Due to the rise of remote work policies stemming from the COVID-19 pandemic, in person laboratory auditing has been nearly impossible over the past year. Reacting to these difficulties, the FDA announced in March of 2020 that they would be scaling...
Tags: Compliance, audit, fda audit, laboratory industry
Maintaining regulatory compliance while making a product that provides value to your customers can be a daunting task, especially if you are using outdated, manual methods for quality management. Increasing efficiency and reducing instances of...
Tags: document control, Compliance, document workflow automation, automation, regulatory
If your company is required to adhere to FDA 21 CFR Part 11 compliance, a document management system can make this process simple. However, not every system is built the same, and there are certain features your company should look for in a DMS...
Tags: 21 CFR compliance, Compliance, Document Compliance Software