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Showing posts tagged with: qmsWrapper

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Validating or Not Validating for Intended Use?

Validating or Not Validating for Intended Use?

When I say Validation For Intended Use, most of you picture an extensive documentation required by ISO and FDA. Although Validation for intended use documentation is useful for several reasons (ensure accuracy, reliability, consistent intended performance, the ability to discern invalid or altered records, etc.) people mainly think of it as a regulatory requirement only. In FDA's...
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Weekly Cup of Joe #27 – Validating With The Wrong Requirements

Weekly Cup of Joe #27 – Validating With The Wrong Requirements

Whether you are freshly minted into the QMS position or you are a founder of a Startup, or a product manager with a new project... your strategy requires QMS oversight. QMS Joe will guide you with handy tips & tricks to streamline your way to compliance. Validating your system for FDA and ISO Both FDA and ISO13485...
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The Quality Manual F.A.Q. – Quality Manual Writing Tips

The Quality Manual F.A.Q. – Quality Manual Writing Tips

To pass a certification body audit, a Quality Management System must be an auditable entity with a neat Quality Manual. How to get useful ‘written stuff’? For hints on what to do, see the Quality manual writing tips part 2, in this short and clear infographic we collected 13 of the top F.A.Q.s and answers. If you want...
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Advantages of Cloud Based QMS and Project Management Software

Advantages of Cloud Based QMS and Project Management Software

Advantages in numbers Every industry or organization is working hard to achieve success and to ensure their service and product safety. Nowadays, it is hard to imagine the work without an electronic, cloud-based QMS or project management tool.  Cloud-based tools are the most searched software today, they are easy to obtain through the internet, they are flexible,...
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The Purpose of a Quality Management System

The Purpose of a Quality Management System

Small businesses typically face a struggle to succeed in a competitive MedDev marketplace. Companies that offer quality services or products are better positioned to not only survive but prosper. A well-managed QMS is paramount to success.   What is a good Quality Management System? QMS systems come in all flavors and shapes, some are industry-specific, others more general,...
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QMS for Beginners – A quick guide on where to Start ! …Part 4

QMS for Beginners – A quick guide on where to Start ! …Part 4

  12. Customer Support and Life Cycle management Customer support is not the issue at this time. You need to develop and finish your product first, then get it cleared through FDA and CE Approved. You need a system that’s focused on those issues. Don’t get confused by these future requirements. There is time enough to figure...
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QMS for Beginners – A quick guide on where to Start ! …Part 3

QMS for Beginners – A quick guide on where to Start ! …Part 3

  The 13 items that will guide you through the implementation of QMS ...Let's pick up where we left off !   8. Selecting the right system to support your Compliance Compliance Solutions are essentially QMS based solutions. They come in all shapes and sizes. Some solutions, such as ZenQMS are nothing more than forms tacked on to a project management...
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QMS for Beginners – A quick guide on where to Start ! …Part 2

QMS for Beginners – A quick guide on where to Start ! …Part 2

  The 13 items that will guide you through the implementation of QMS - continues...   4. Organizing the work Next you will need to define the flow of how work gets done within your organization, i.e. the workflows. Why, because you need to understand where compliance issues will fit in. Workflows can show you the path tasks take through your organization… i.e....
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Project management and quality management 2017 - smart solution

Project management and quality management 2017 - smart solution

qmsWrapper is 1 system with 5 modules   and if you thought project management couldn't include QMS... think again...    In a global environment, companies are facing countless complex and unique industry challenges. Quality becomes not just a buzzword but a true competitive advantage – companies that deliver the best quality products and services efficiently - succeed. Today’s QMS and...
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The Dawn of Integrated QMS… Part 2

The Dawn of Integrated QMS… Part 2

qmsWrapper, the leading integrated QMS system specifically aimed at compliance  qmsWrapper has Compliance in its DNA. Since developed by a medical device company, the priority was to design a QMS application that solves many challenges facing medical device startups and small companies. Based on Project, Quality, Risk, and Document Management with a truly comprehensive Team messaging. In qmsWrapper,...
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The Temptation of ISO 13485 Template Kits

The Temptation of ISO 13485 Template Kits

Be careful what you use when building up your QMS system! The expanding Internet means more: more data, more collaboration, and more complex systems of interactions. You can find hundreds of both expensive and free templates for ISO 13485, offered by various consultants, companies and experts. But even if the ISO compliance is guaranteed on some...
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New Feature Announcement: "My Team", for qmsWrapper

New Feature Announcement: "My Team", for qmsWrapper

We are pleased to announce the release of the new team managing tool - My Team, in the Project Management Module for qmsWrapper. Projects are about teams, but the biggest project of all is managing your team. Announcing “My Team”, the newest element of qmsWrapper. “My Team” is a new module that gives managers the ability to...
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Creative Collaboration, Collaborative Compliance

Creative Collaboration, Collaborative Compliance

It’s official, workplace emails are an ineffective tool for managing projects. Don’t confuse Emailing a link to your team as collaboration - that’s ping-pong! And sending your team an email and asking them to either comment or provide input on a file, an idea, a suggestion is like trying to push a wet string. Although email...
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QMS Processes & ISO Compliance (ISO compliance in the business world and QMS processes)

QMS Processes & ISO Compliance (ISO compliance in the business world and QMS processes)

In a global environment, companies are facing countless complex, unique industry challenges. Quality becomes not just a buzzword but a true competitive advantage – companies that deliver the best quality products and services efficiently - succeed.     ISO certification, (be it ISO9001, ISO13485…)  communicates a commitment to quality to both customers and regulators. There are many benefits...
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Wrapper – Let’s Start Managing Through Quality

Wrapper – Let’s Start Managing Through Quality

An innovative approach to tackle the challenges of modern business - Management Through Quality™ qmsWrapper is a smart management software that effectively avoids adding another layer of management by encouraging team-based collaboration compliance. qmsWrapper is for any company needing a powerful, unified platform to help the teamwork more effectively together. qmsWrapper provides the means for teams to...
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