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The FDA’s Quality Management System Regulation now builds on ISO 13485:2016. Here is what changed, what investigators will look for, and how ENSUR supports the ISO 13485 workflows your quality system runs on every day.
Tags: document control software, quality management software, Electronic Signature, Compliance, audit readiness, 21 CFR Part 11, FDA
A practical guide to the 21 CFR Part 11 criteria your e-signature workflow must meet, and how to evaluate the systems that claim to meet them.
Tags: document control software, quality management software, Electronic Signature, Compliance, audit readiness, 21 CFR Part 11, FDA
Taking control of documentation at your business can prevent costly mistakes, simplify approvals, and streamline audits. Depending on your business needs, a document control system (DCS) or quality management system (QMS) should be implemented. It’s...
Tags: document control software, ENSUR, Quality Management System
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
Dave Ahrens is a Software Architect at DocXellent, and he holds the record as our longest standing employee. He has been with our company for over 20 years! Dave currently lives in Voluntown, CT and was born and raised in Milford, CT. He is...
Tags: document control software, document management software, employee spotlight, software architect
The act of on-boarding new employees is an essential part of any company’s human resources management. However, it can often be a complicated process when trying to manage endless paperwork while also coordinating training on company policies and...
Tags: document control software, document management software, training management software, Quality Management System, training management system
Change is constant—especially for businesses that must prove regulatory compliance with documentation for federal, state, and local governments. Small, medium, and large companies must all verify and document that they operate within all applicable...
Tags: change control, document control software, document management software, quality control software
It’s hard to imagine an industry better positioned to experience the benefits of a document management system than the cannabis industry. In 2019, the cannabis industry will continue to grow, but surmounting the regulatory, financial and safety...
Tags: document control software, document management software, document management system, Quality Management System, cannabis industry, document control for the cannabis industry
An excellent document management software should make an organization's life easier and more efficient. Yet, many organizations still use file cabinets jammed with paper, or cumbersome on-site servers that are highly error-prone and don’t have a...
Tags: document control software, document management software, document management system, Quality Management System
Power, heat, cooling, light, security, sanitation, and communication systems power homes and businesses in essential ways most people take for granted until they fail. Utility companies need reliable tools to help them improve their processes as...
Tags: document control software, document management software, document management system, Quality Management System, utilities industry document control