Showing posts tagged with: qmsWrapper

TM is now more effective and useful feature that serves as a dashboard for product development leading to submission. You build your Traceability Matrix as you develop your product... Key functions of qmsWrapper Traceability Matrix: track and show the relationships and connections between requirements end to end traceability design controls, by column tracking number automatically assigned and inherited export into a print-ready...

Now Medical Device startups and small businesses that use Jira can be connected to qmsWrapper. This integration will help medical device companies reduce their development risks and increase their agile effectiveness, whilst still keeping an eye on quality. “qmsWrapper got its name because it originally designed to ‘wrap’ Jira in a QMS blanket, to take advantage...

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...

What is the root cause analysis? Root Cause Analysis is something that we all do when we want to solve a problem for good. But what RCA actually means? It means to find what caused the problem, to find out not only what went wrong in the beginning, but how, when and why as well. Basically, RCA is...

It's one thing to become ISO certified, but maintaining the certification is another thing with all the updates and new records. Besides following the processes and procedures that were set, it's also required to improve processes and all recorded as evidence. That means keeping up with your documentation, updating procedures when the processes change, modify work...

At work, nothing raises the hairs on the back of your neck like the word “audit”. What audit means to you? Audits mean fault, mistake, short-coming and blame, fault, culpability all wrapped in disappointment – you have failed!  The bullies incorporate love them! But the wise manager embraced them and uses them to pre-empt the bullies, by...

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...

Most of the startups and small companies have a problem with organizing folders, especially if they are still using a paper-based QMS. Where is this file? Is it under review? Is this draft version? Is it approved? The need to check it and review it, then approve can take time and mistakes can be weird...

Problems are always going to arise for any business no matter how hard you try to avoid them. While you can’t run a perfect business with all smooth situations, at qmsWrapper we can ensure friction doesn’t become an issue. You can always voice your challenges, we treat every issue as special, and not just another...

Audit – a word that inspires anxiety. Even when everything is well planned, and you think you are prepared, anticipation turns to anxiety, anxiety to fear, and fear to panic. There is no hiding anything in a remote closet or under the carpet. “Wherever you've hidden it, we'll find it.” Audit Senior It's an audit day! In the beginning,...

The new version of qmsWrapper is updated in December 2019. We were still shaking from a disastrous ISO audit. Joe, the perennial QMS manager from Jurassic times, just have been fired. Even though he liked pushing the paper-based system, a medical device company has too many regulatory pitfalls to trip you up. Brilliant engineers and developers just...

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...

It takes the same amount of time and effort to create a good quality manual as it does a bad one. Oftentimes, far less... In this article, we will discuss how to establish, operate and maintain a good one: Introduction (what is a QM, and what should include) Common mistakes in establishing a QM, and how to avoid them Pro...

Without proper employee training, business will likely see minimum success. Smart companies invest in the development of their employees. QMS Joe will guide you with handy tips & tricks to streamline your way to compliance.  Employee Training is deemed as the most important thing where the employees feel valued and develop an attachment to the overall mission of...

Tips and guidelines to create an efficient workforce and keep your business functioning at a high level. (ISO 9001, ISO13485, FDA510K)   Nobody wants to hire a person that is unable to do a job to a satisfactory standard. This is especially true when it comes to QMS related functions and activities. Besides, the candidate’s adequate competency...

The most important part of the manual is the description of the QMS The quality manual provides a wide range of benefits for organizations. Besides, that is easy to follow, it covers almost everything that company and its employees need to know about the ISO standards and what is expected of your quality management system. A bad...

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...

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...

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...

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,...

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,...

  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...

  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...

  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....

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, you’re reading this because your strategy requires QMS oversight and your first question is likely "Where to Start” and “What to Do” We could squeeze in 5 main points the initial...