Showing posts tagged with: qmsWrapper

When an eQMS is implemented in a medical device company, such software must be validated.  It should be ensured that the system is working and that it meets the requirements of ISO 13485. Validating the software decreases risk and legal liability, and provides evidence that the system fits for purpose.   Software validation process Validation for intended use...

  The importance of the Traceability Matrix (TM) tool comes from the fact that it connects requirements and uses cases to design inputs, outputs, testing, Risk Controls, and Risk Management. And Design Controls can be seen as practices, policies, and procedures that formally govern the design and development process for your product. So how design control works within...

  qmsWrapper provides a Search and Report tool that allows you to track the progress of all activities in your company, and it will make monitoring them very easy. You can check whether certain action achieves planned results, and to take appropriate measures in time if determined it doesn’t. ‘Search and Report’ is a module added to...

  Quality Management System shows its power exactly through powerful document control management process while Document Change management is the process that is in charge of controlling the life-cycle of all changes in your QMS. Theoretically goes like this: Request a change Submitting and reviewing the change request Changing the Request Response Document Final Decision and Approval A change request is the...

  Achieving and maintaining compliance is not an easy job as both ISO and FDA regulations require documents to be approved before they are officially distributed or used either inside or outside the company. Document Management System is designed to support compliance, it includes version control, detailed file histories, file tracking, source tagging, comments, authority control. A...

  Even birds on a tree know that good QMS documentation is essential for effective implementation and maintenance of QMS within an organization. But beginners involved in QMS often think of Document management as something so general that it is required by any industry and by most processes within any business. OK, but what is document management...

  It’s really important to understand the system, for better understanding the processes that occur within the system. qmsWrapper is made in a way that any user should easily be able to implement a process. Each process has its scope. They have their beginning and their ending. In the previous use case, qmsWrapper’s process approach is discussed. Processes...

  QMS standards are based on the process approach which means - any activity that receives input and converts it to output can be considered as a process.  There are many ways to describe the process approach: A process is a set of inter-related activities that use resources (people, machines, etc.). If you look at it closely, every...

  Unlike the documents, records are created when something is done and you need to record any data or event. It's evidence about the past event. Documents can be revised and changed, whereas records don’t (must not) change. If additional facts occur that contradict the old facts (an error), then you should cross out the old...

  qmsWrapper is always looking to introduce an innovative approach to tackle the challenges of quality in modern business. Management that puts quality in every aspect is smart management that effectively avoids an additional layer of bureaucracy to the daily work. When it comes to recording any event in the qmsWrapper, it's important to understand that its...

  Standards require that documents are approved before they are officially distributed or used either inside or outside the company. Approval processes are supporting the accurate recording of acceptance or agreement in business documents, policies, work instructions, and more. They can add value to an existing workflow by creating consistency by always requiring approval when certain conditions...

  A QMS should include a clear and updated model of the organization's structure and responsibilities of all individuals within the organization. In qmsWrapper, you can define and assign different QMS roles to different employee based on the company’s needs, size, and organization type. If an employee gets a defined QMS role, it means that they have...

A library is an integral part of any community. They provide information and resources. So why not one in qmsWrapper, more than storage it’s a favorite place to keep important documents that need to be accessed by all. For example, standards, marketing documents, graphics used by all… endless reasons really. It’s the one easy-access place to...

Over the last few years, it’s a noticeable progressive growth in the global market in the adoption of software for quality management systems. The automation of the Quality Management System significantly eases the potential risks and operational costs of conformance to regulatory requirements in any sector or industry type. The need for effective management of...

You know those moments when you have software for handling the big things, but small processes end up taking an unreasonable amount of time and energy? That’s why qmsWrapper is always trying to take an innovative approach for better workflow. This time it comes out with a “Custom issue forms”! It will empower your team to...

qmsWrapper is a successful company promoting the organizational framework that provides structure to the processes, policies, procedures, and resources to implement the Quality Management System for medical device startups. Behind every successful company stands the skillful team. But the key role of such a team that leads to success is someone who is organized, passionate,...

We live in a time of technological evolution and the medical device industry is no exception. Technology advances day-by-day. The Wetling Company, with its revolutionary new wound-healing technology, is one such example. Their mission is to ease ailments caused by chronic and acute wounds, through a patented and revolutionary wound-healing method referred to as WMCS –...

Research on the global medical QMS software market in 2020 describes the supply and demand situation, market landscape, and competitive scenario. The analysis is focused on the current trends done under the supervision of business specialists. The QMS market is starting to witness tremendous growth due to the increasing demand for effective management of organizational processes and...

qmsWrapper has many Users who have been renewing their license for several years now, showing how satisfied they are with this QMS software. qmsWrapper is intended for startups and small size companies engaged in the development of medical devices. The software is ideal for those who are switching from paper-based to eQMS without having experience with...

One of qmsWrappers’s main priorities is Quality and Responsibility. As the situation with regards to the coronavirus (COVID-19) outbreak is evolving rapidly, we have made certain steps following the situation. Therefore qmsWrapper has taken into consideration the effects of the COVID-19 outbreak, we have analyzed our processes and we have implemented a contingency plan in...

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...