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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 42# - Dealing with CAPA

Cup of Joe 42# - Dealing with CAPA

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. 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 data...
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Cup of Joe 41# - 4 reasons - why eQMS over paper-based QMS

Cup of Joe 41# - 4 reasons - why eQMS over paper-based QMS

When implementing and maintain ISO standard such as ISO 13485, it is burdensome to maintain paper-based documentation and it’s very time-consuming. It is quite a struggle to find information when needed in the thick of ‘forest’ of document history. Good organization is essential for a guaranteed successful business. There are few reasons for choosing an eQMS...
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CAPA Checklist - Step by Step Guide

CAPA Checklist - Step by Step Guide

CAPA – Corrective action Preventive action The purpose of corrective and preventive action is to collect and inspect information, identify and examine product or potential quality problem, then take suitable and effective corrective/preventive action. It’s a process of improvement taken to eliminate causes of possible malfunction, problem or another unwanted situation.  It’s also a process which auditor...
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Correct way to follow procedures and processes

Correct way to follow procedures and processes

Every company has as part of its organization set of procedures and processes. The purpose of having procedures is to drive efficiencies towards fewer errors and resulting reworks, which can improve cost saving. Besides that, their purpose is also to make sure they are in compliance with regulations. The procedure is correct, but are the follow-ups...
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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 39# - Key factor during an audit–prepared employees

Cup of Joe 39# - Key factor during an audit–prepared employees

A successful audit relies on communication. So, the preparation of employees in order to know exactly how to interact with the auditors when they arrive is one of the most important steps. This means Meeting! If the staff members are able to work collaboratively with the auditors, the audit will be conducted more efficiently, and...
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Cup of Joe 38# - There is such a thing like painless audit?

Cup of Joe 38# - There is such a thing like painless audit?

An audit is verification of activities – process or quality system in order to ensure compliance to 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 painless. Standard...
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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”. 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 self-auditing.   The more positive...
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Cup of Joe 36# - Scary word “Audit”

Cup of Joe 36# - Scary word “Audit”

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 the reduction, elimination and most importantly, prevention of...
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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. Many 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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Cup of Joe 32# - Good Customer Service Reduces Problems

Cup of Joe 32# - Good Customer Service Reduces Problems

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...
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Weekly Cup of Joe 31# - Move Your Budget into the Right Direction

Weekly Cup of Joe 31# - Move Your Budget into the Right Direction

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. The problem is with so many QMS software out there to choose from, how do you know which...
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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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