Showing posts tagged with: QMS

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...

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...

Preparation of the QMS documentation is based on the organizational needs, and it is crucial for an efficient QMS. Besides, correctly organized documentation will make operations much easier.   The purpose of QMS documentation is to provide a clear framework for the company’s operations and a better understanding of the QMS, and finally to show the evidence...

Perfect, now when you have learned about the ISO 13485 standard with the help of 20 lessons explained on this website, now you are ready to implement it. The first step is to perform a GAP analysis. We won't leave you hanging at this part now, so we explained it to you as well.   You might wonder how can...

ISO 9001 sets out the criteria for a quality management system. Quality Management System (QMS) ensures that an organization, product or service is consistent. It is a collection of business processes focused on consistently meeting customer requirements and enhancing their satisfaction. It is aligned with an organization's purpose and strategic direction. It is expressed as the organizational...

Conferences, summits – why are they so important Well, there are many reasons to attend a conference. Regardless of the current COVID-19 outbreak, this does not mean that you shouldn’t plan the next step for growing your business.  One way of growing your business is by attending conferences. If you are attending, it’s more likely that you...

It is not easy to build a Medical Device. And we all know that every beginning is hard. Therefore, for startups, it’s quite a challenge. But fear not. More you know, easier it is. Since the 2000s, MedDev startups have become more important in the global economy and the business environment is changing accordingly. To survive...

As never before, during such technological opportunities and critical situations like this one, there is a necessity for such rapid reactions as it is now. If you are a medical device startup, or small business certainly you are holding your head that is filled with concern right now. You wonder how to minimalize the impact caused...

Massive update of the year is happening and qmsWrapper’s Users will be thrilled to find out what is new in one of the 4 upgrades – Process Engine. qmsWrapper’s core functionality was transformed from a tasks-based system to an enterprise-grade Processing Engine – to better support and enable your business workflows. Along with the Process Editor, business...

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...

Before making any big decision, it’s always recommendable to think it through. It’s not an easy task to find a good outsourced manufacturer for your needs, for your medical device that should conquer the market. Especially if you don’t know much about the technical part but you are aware of what your product’s requirements are, getting...

  When someone owns a medical device company, but not having a space or supplies for producing equipment, then they hire a contractor, outsourced manufacturer. So, he is providing all the services regarding life-cycle products. If you think you've taken a heavy load off your back, you are wrong. Please, read the regulations and standards again. Let us remind...

“Efficiency without Effectiveness misses the Purpose Effectiveness without Efficiency misses all the Profit Effectiveness with Efficiency brings Performance.” ― Martin U.  Ugwu   Verifying the effectiveness of corrective and preventive actions (CAPAs) closes the loop between identifying a problem and completing the actions to solve it. Reminder: The main purpose of corrective and preventive actions (CAPA) is to improve the organization processes...

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...

CAPA is a system that consists of improvements taken to eliminate the causes of non-conformities or any other undesirable situation within an organization’s process. CAPA importance Every company should develop a strategy for CAPA as part of its overall quality system. To manage the suitable CAPA activity, it is important to track, manage and evaluate all different quality...

CAPA – Corrective action Preventive action The purpose of corrective and preventive action is to collect and inspect information, identify and examine the product or potential quality problems, then take suitable and effective corrective/preventive action. It’s a process of improvement taken to eliminate causes of possible malfunction, problems, or other unwanted situations.  It’s also a process that...

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...

An audit is the verification of activities – process or quality system in order to ensure compliance with some requirements. As such audits always generate tension and anxiety – because you know that some stranger is coming to check your work and could give you a failing grade! Painless = prepared, the more prepared, the more...

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...

An Audit is the on-site verification activity of a process or quality system, to ensure compliance to requirements. An audit can apply to an entire organization or might be specific to a function, process, or production step. A system audit also delivers objective evidence concerning the need for a reduction, elimination and most importantly, prevention of...

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...

One of the main fears when transferring from paper-based to eQMS is how to handle a lot of file versions, how should we name them, should we import every single version? You just need to upload the latest version without the number of that version (for example “Technical file”) and make a note in the file...

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...

There are countless benefits to implement a quality management system. We can all agree that an organization’s quality performance affects its bottom line. So, think of the investment in modern QMS software as an investment in preventing quality issues. How to choose the right software? The problem is with so many QMS software out there to choose from,...

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,...