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Weekly Cup of Joe 30# – DHFs & CE Technicals with Traceability Matrix

Weekly Cup of Joe 30# – DHFs & CE Technicals with Traceability Matrix

An effective traceability process is essential requirements when developing medical device software and to achieving regulatory compliance. Traceability Matrix can be very difficult to create, it can take months to put together manually, especially without a proper tool. Creating and maintaining a TM can be time-consuming and difficult not to mention all those messy spreadsheets and ongoing...
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qmsWrapper - Custom Forms and Form Editor- Clever, Efficient and Flexible!

qmsWrapper - Custom Forms and Form Editor- Clever, Efficient and Flexible!

  qmsWrapper - Work smarter, faster with fewer errors    “As the product lead for qmsWrapper’s new Forms and Form Editor feature, I’m happy to say that we’ve completed the beta testing process. If you’re a qmsWrapper user, you could start using this helpful feature since last week!” – George Tailor “Finally, a Form Editor! After Process Editor, we...
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Weekly Cup of Joe 29# – Customer Feedback is a Wealth of Information

Weekly Cup of Joe 29# – Customer Feedback is a Wealth of Information

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.   Improve Customer Retention and Ensure That You Keep the Finger on...
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Weekly Cup of Joe #28 – Is Employee Training Worth the Investment?

Weekly Cup of Joe #28 – Is Employee Training Worth the Investment?

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.   Convert Employee Training into the Workplace Don't try to save money on...
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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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Weekly Cup of Joe #26 – Advantages of An Integrated PM and QMS

Weekly Cup of Joe #26 – Advantages of An Integrated PM and QMS

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. Bolt-on Quality Management Apps, put the cart before the horse The mistake...
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Weekly Cup of Joe #25– Documenting Opportunities to Improve

Weekly Cup of Joe #25– Documenting Opportunities to Improve

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. MS Joe will guide you with handy tips & tricks to streamline your way to compliance.   The Relation Between Risk Assessment and Opportunities to Improve Companies often fail to...
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Weekly Cup of Joe #24 - Data Backup and Recovery Plan in QMS

Weekly Cup of Joe #24 - Data Backup and Recovery Plan in QMS

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.   Why Every Small Business Needs a Backup and Disaster Recovery Plan? Nobody wants...
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Weekly Cup of Joe #23– Corrective and Preventive Action (CAPA)

Weekly Cup of Joe #23– Corrective and Preventive Action (CAPA)

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.   Are Corrective Actions More Important Than Preventive Actions? Although CAPA is...
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Weekly Cup of Joe #22 – Risk Management Strategy in QMS

Weekly Cup of Joe #22 – Risk Management Strategy in QMS

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.   Deer, Rabbits and Fast Snails, Risk is About Context Risk management...
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Hidden Pitfalls in the Risk Management Strategy

Hidden Pitfalls in the Risk Management Strategy

In our fast-paced world, the risks we have to take and manage, in order to continue to grow and to develop, evolve quickly. Effectively managed risks help companies achieve their goals. Products that are developed following quality standards, have improved the quality of life for thousands of people. The ideal of improving the quality of life...
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Weekly Cup of Joe #21 – References on Obsolete QMS Documents

Weekly Cup of Joe #21 – References on Obsolete QMS Documents

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.   The importance of identifying and updating all the documents that...
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​ISO Audit and the Company Image

​ISO Audit and the Company Image

The Company must have a true picture of itself. It is not enough to possess the required information related to legislation, internal and external issues and interested parties, all this data should be properly documented, this information has to be available to the relevant project team members, who have to ensure the right policies are...
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Weekly Cup of Joe #19 –Projects in Wrong Place and Time

Weekly Cup of Joe #19 –Projects in Wrong Place and Time

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.   Determining Project Requirements Project requirements are one of the first things...
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Why is it Important to Select Your Suppliers Carefully

Why is it Important to Select Your Suppliers Carefully

Selecting suppliers is not an easy job. The pitfall is usually in the haste. If the responsible employee has a very short deadline to evaluate the suppliers, they tend to simply accept the first offer they get. Without proper evaluation or not taking the time to look for other potential suppliers, you may end up...
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Weekly Cup of Joe #17 –Don’t Buy Pig in a Poke!

Weekly Cup of Joe #17 –Don’t Buy Pig in a Poke!

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.   Approving Documents with One Click Obtaining approval from a group...
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Weekly Cup of Joe #16 – Document Search Requirements in the QMS

Weekly Cup of Joe #16 – Document Search Requirements in the QMS

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.   A properly designed Document Control and Management Chasing document traceability can...
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Weekly Cup of Joe #14 – QMS Documentation

Weekly Cup of Joe #14 – QMS Documentation

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.     How to put together a QMS documentation successfully? Properly structured...
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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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