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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...
For medical device manufacturers, meeting compliance standards is an essential piece of the quality process. One of the most important of these necessary regulations is FDA 21 CFR Part 820, which ensures that medical devices are safe and effective....
Tags: FDA Compliant Document Control Software, medical device regulations, FDA 21 CFR Part 820
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
According to recent data from the Centers for Disease Control and Prevention, about 48 million people in the U.S. get sick, 128,000 are hospitalized, and 3,000 die each year from foodborne diseases. The recent changes to the FDA’s Food Safety...
Tags: FDA compliance software, fda guidelines, food and beverage industry, fsma
With consumers placing an increasingly large emphasis on product quality, meeting regulatory standards like ISO 9001 is more important than ever. To keep up with the ISO 9001 group of standards, many companies find a digital quality management...
Tags: quality management software system, quality management software, ISO 9001, internal audit
Joe Ciriello is DocXellent’s Business Development Manager and resident nature enthusiast. In this development role, he works on sales expansion in the private, public, and government sectors, growing the organization one sale at a time. He also...
Tags: employee spotlight, DocXellent Employees, document management software company, sales team
No matter how many vendors your company works with, creating an efficient supplier management process and fostering strong relationships with them is essential. When your business success is dependent on third parties to help you deliver your...
Tags: document management software, save money, supplier collaboration, vendor collaboration, supplier management software
We interviewed DocXellent's resident quality audit expert and Chief Technology Officer, Tom Tassias, to learn from his extensive experience with third-party audits and get his insight into how companies can optimize their audit process to improve...
Tags: document control software, audit, audit readiness, 3rd party audit, quality audit
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