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According to the FDA, inadequate standard operating procedures (SOPs) are one of the most frequently cited causes of non-compliance warning letters. And while a poorly written SOP can cause a multitude of additional major compliance problems, a...
Tags: document control, FDA Compliant Document Control Software, fda guidelines, sop management, what are sops
For medical device companies, meeting ISO 13485 standards is necessary for many reasons. The standard was written to support medical device manufacturers in designing a Quality Management System that establishes and maintains the effectiveness of...
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....
Tags: document management, Compliance, biotechnology industry, audit readiness
What is the Best Document Control System?
Every year, we talk to hundreds of document control, quality, and regulatory professionals who are looking for a better solution for managing their document control process. And because so many of them know...
Tags: document management software, dms software, top document management, document management software reviews
For companies in the life science industry, regulators require an official process for managing their corrective and preventative actions (CAPAs). Additionally, a strong CAPA workflow is necessary for audit preparation, maximizing cost savings,...
Tags: Quality Management System, CAPA management, CAPA Workflow, life sciences
If you want to ensure you are providing consistent products or services throughout your organization, you must implement an ironclad quality management system, or QMS. Quality control management ensures that what your company delivers, and the...
Tags: FDA compliance software, Quality Control Management, quality management, quality management software, quality management software systems
Maddy Hemberger is DocXellent’s Marketing Assistant, a dedicated runner, and a travel and adventure enthusiast. As an integral member of our Marketing team, she helps with ongoing marketing campaigns by creating content and conducting different...
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
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