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Showing posts tagged with: qmsWrapper

qmsWrapper in 2022

qmsWrapper in 2022

There is still a little time left until the end of 2022, so it is the right time to sum it up and set new goals for 2023. The qmsWrapper team has been working on the development of the software and brought many updates to old and new users. We had difficulty finding a solution for...
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qmsWrapper received another badge for Fall 2022

qmsWrapper received another badge for Fall 2022

Autumn has arrived and with it another recognition from our clients, which they expressed through the G2 portal. This year contained a lot of upgrades and special customization to fully support our client's needs and equip the qmsWrapper family with the latest QMS features. The good work is now rewarded with another recognition from one of...
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QMS Tags

QMS Tags

Audit day, the feared day. But does it have to be that way? Imagine a situation where your auditor is amused because you have prepared all the necessary documentation that has to be presented, all in excellent order, accessible through excellent software. Organize yourself in time, and your documentation… Some documents are certainly valid from the...
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Upgraded Dashboard and QMS Control

Upgraded Dashboard and QMS Control

Change can be daunting, but sometimes change just makes sense. qmsWrapper has developed a better way to access QMS functionality in qmsWrapper. It’s a new UI or Dashboard, and QMS Control Tables. Fear not, the essential underlying function remains unchanged. How you access the data does. The new dashboard puts more QMS functionality at your users' fingertips. First, we introduced Tabs...
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qmsWrapper Notifications - included!

qmsWrapper Notifications - included!

Have you received a document that needs your approval? If you did, do you know when? How do you know if it is urgent? The advantage of QMS software is the efficiency on a higher level compared to a paper-based QMS. With eQMS all documents can be created in a short time, easily sent for approval, get...
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Validation efforts

Validation efforts

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...
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The library – feature for the rest of the company

The library – feature for the rest of the company

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...
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qmsWrapper now covers and supports ISO 9001:2015

qmsWrapper now covers and supports ISO 9001:2015

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...
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Custom Templates according to your needs

Custom Templates according to your needs

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...
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Meet qmsWrapper’s Project Manager and find out more about new features

Meet qmsWrapper’s Project Manager and find out more about new features

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,...
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The Wetling Company’s eQMS-journey

The Wetling Company’s eQMS-journey

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 –...
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qmsWrapper’s growth on the market

qmsWrapper’s growth on the market

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...
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Interview with one of qmsWrapper’s successful User

Interview with one of qmsWrapper’s successful User

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...
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qmsWrapper – Coronavirus (Covid-19) Statement

qmsWrapper – Coronavirus (Covid-19) Statement

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...
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A new Traceability Matrix so powerful, it becomes the products dashboard

A new Traceability Matrix so powerful, it becomes the products dashboard

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...
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Jira is now “wrapped” with qmsWrapper

Jira is now “wrapped” with qmsWrapper

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...
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Cup of Joe #46 - New superpower for MedDev through qmsWrappers TM

Cup of Joe #46 - New superpower for MedDev through qmsWrappers TM

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...
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Cup of Joe 43# - Treat the cause, not the symptom

Cup of Joe 43# - Treat the cause, not the symptom

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...
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Cup of Joe 40# - Documents and procedures amendment

Cup of Joe 40# - Documents and procedures amendment

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...
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Cup of Joe 37# - Why we have to perform an audit?

Cup of Joe 37# - Why we have to perform an audit?

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...
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Cup of Joe 35# - Signing your electronic documents

Cup of Joe 35# - Signing your electronic documents

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...
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Cup of Joe 34# - How to organize your folders?

Cup of Joe 34# - How to organize your folders?

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...
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