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We are excited to announce the addition of three new members to DocXellent: David Conde to our Technical Support Department, and Christine Allard and Nathan Bousquet to our Customer Relations Department!
For manufacturing and packaging professionals, it’s once again time to start planning for the coming business year – and looking to the future of Specification Management and how you can innovate your processes is a great first step. While your...
Tags: cloud, Spec Management, cloud spec management, 2023 trends
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...
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