Showing posts tagged with: quality management system

ISO 9001 sets out the criteria for a quality management system. Quality Management System (QMS) ensures that an organization, product or service is consistent. It is a collection of business processes focused on consistently meeting customer requirements and enhancing their satisfaction. It is aligned with an organization's purpose and strategic direction. It is expressed as the organizational...

Conferences, summits – why are they so important Well, there are many reasons to attend a conference. Regardless of the current COVID-19 outbreak, this does not mean that you shouldn’t plan the next step for growing your business.  One way of growing your business is by attending conferences. If you are attending, it’s more likely that you...

New version 6.0 of qmsWrapper is finally out and brings us 4 major updates: Integration with Jira Software, upgraded Traceability Matrix, New Risk Module, and Process Engine. What are the benefits and why is now a perfect time for subscribing to the best QMS software for medical device startups find out on our white paper.

Last week qmsWrapper announced the greatest upgrade of the year. New updates are Integration with Jira Software, updated Risk Module, and Process Engine and, best for the last - upgraded Traceability Matrix! Joe will introduce you to the first one of the super upgraded Traceability Matrix. Traceability Matrix with an issue Working in TM in the past had a...

  When someone owns a medical device company, but not having a space or supplies for producing equipment, then they hire a contractor, outsourced manufacturer. So, he is providing all the services regarding life-cycle products. If you think you've taken a heavy load off your back, you are wrong. Please, read the regulations and standards again. Let us remind...

An audit is the verification of activities – process or quality system in order to ensure compliance with some requirements. As such audits always generate tension and anxiety – because you know that some stranger is coming to check your work and could give you a failing grade! Painless = prepared, the more prepared, the more...

One of the main criteria for an eQMS is to have implemented an electronic signature. Much eQMS software have found many ways to handle this issue, but they all have to satisfy 21 CFR part 11. This part clearly paraphrases the fundamental rules of electronic signature implementation and control for compliance needs. When we are talking about...

There are countless benefits to implement a quality management system. We can all agree that an organization’s quality performance affects its bottom line. So, think of the investment in modern QMS software as an investment in preventing quality issues. How to choose the right software? The problem is with so many QMS software out there to choose from,...