Can't find what you're looking for? Try another search!
[…] had filed 8,120 MDR applications, up from 6,188 in April. Applications are growing faster than MDR certifications, which rose from 1,069 in April to 1,990 in the latest survey. Commission Survey EDQM strikes agreement with EU to support substances of human origin regulatory framework The European Directorate for the Quality of Medicines & HealthCare […]
[…] 4. Lack of Context: Trace matrices only provide a static view of the system and do not capture the dynamic context in which the system operates. For example, a requirement may be met by a design element, but the design element may have unintended consequences when combined with other elements in the system. Trace […]
[…] each requirement or highlight the changes between versions. 3. No traceability There’s so much room for error through email chains and undisclosed updates. It’s incredibly simple, for example, to miss a tiny change that could have critical ramifications upstream or downstream. 4. Reviews are time consuming Without traceability, review cycles with an enormous document […]
[…] series. My name is Atef Ghribi and I am a senior solution architect at Jama Software. Today, we’ll be looking at the Git repositories integration using an example of a repository in GitLab. We make it possible for you to integrate Jama Connect with the preferred best-of-breed software to achieve Live Traceability™ across the […]
[…] Compliance 1: Diverse and Evolving Regulation Complexity: Different industries are governed by a myriad of regulatory bodies, each with its own set of rules and standards. For example, the medical device industry must comply with FDA regulations in the U.S., CE marking in Europe, and various other international standards. Evolution: Regulations are not static; […]
[…] they are. Our autonomous transport customer Einride relies on those same collaborative features to communicate critical changes to remote teams as part of their daily operations. For example: Einride develops features at a fast pace, often enhancing the functionalities of their electric freight vehicles after they’re deployed. Teams need to react fast and change […]
In this post, we discuss why traceability is necessary for building compliant products, and how an audit trail helps strengthen product development, curb the risk of recalls, and contribute to better decision making in the future.
[…] Crucial Role of Traceability in Modern Product and Systems Development 19. Why Investing in Requirements Management Software Makes Business Sense During an Economic Downturn 20. Functional requirements examples and templates 21. Why do you need Requirements Management? 22. Writing Requirements Overview 1 Functional requirements examples and templates 2 Identifying and Measuring Requirements Quality 3 […]
[…] deep. Accomplishing this requires the carpenter to have a drill bit that is capable of drilling two-inch-long holes. The scoping of the project is focused on the materials and processes that go into creating the drill bit that is able to drill a two-inch-deep hole. Typically, requirements are scoped during each phase of a […]
[…] Crucial Role of Traceability in Modern Product and Systems Development 19. Why Investing in Requirements Management Software Makes Business Sense During an Economic Downturn 20. Functional requirements examples and templates 21. Why do you need Requirements Management? 22. Writing Requirements Overview 1 Functional requirements examples and templates 2 Identifying and Measuring Requirements Quality 3 […]