qmsWrapper Blog - Take Back Compliance - The Art of Managing Through Quality
How CAPA should be verified?
“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...
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.
Gone! Audit Day Fears! How Cardio-Phoenix Took the Fear out of an ISO Audit With Help from qmsWrapper
This story starts with a medical device startup, who designs and develops a medical device for the early detection of heart disease at the clinical level.
How to stay on top of your product development and easily organize your FDA and CE submission
qmsWrapper - Custom Forms and Form Editor- Clever, Efficient and Flexible!
Work smarter, faster with fewer errors
Pitfalls and Best Practices in Establishing a Quality Manual
It takes the same amount of time and effort to create a good quality manual as it does a bad one. Oftentimes, far less...
Ultimate Tips and Guidelines to Fine Tune Your Employee Trainings
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.
10 Pitfalls and 13 Best Practices in Establishing a Quality Manual
It takes the same amount of time and effort to create a good quality manual as it does a bad one.
Validating or Not Validating for Intended Use?
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.
The Quality Manual F.A.Q. – Quality Manual Writing Tips
To pass a certification body audit, a Quality Management System must be an auditable entity with a neat Quality Manual.
What if staying ISO and FDA compliant was easy?
A quick reality check of ISO 13485:2016, reveals that it actually looks more, smells more and sounds more, like FDA’s QSR.
The Quality Manual Alias the Quality Bible or the Quality DNA
Quality Manual is the foundation and framework from where you build your organization. It is a plan, which sets the direction and navigates the organization within the defined parameters.
Are companies ready for the ISO 13485:2016? “a closer look”
This is a real and topical question. At every MedDev or MedTec oriented exhibition this is the off-stage topic, actually more like main grippe session.
Do you know how secure your documents really are?
The following infographic will help you recognize the primary causes and warning signs for potential data loss and the top tips for prevention.
Hidden Pitfalls in the Risk Management Strategy
Risk management is one of the key factors in quality management. Effectively managed risks help companies achieve their goals.
Advantages of Cloud Based QMS and Project Management Software
In this infographic, we present the actual percentages of the improvements your company can achieve with a cloud-based QMS or Project management software.
The Purpose of a Quality Management System
Small businesses typically face a struggle to succeed in a competitive marketplace. Companies that offer quality services are better positioned to prosper.
Approval Workflows in QMS
Maintaining compliance is not an easy job. QMS approval processes are supporting the accurate recording of acceptance or agreement in business documents.
Balancing Priorities when everything is #1
If you have several different things that are pressing for your attention and you’re not sure how to prioritize and what to consider, read on.
Documents in a Paperless Office, Find a Needle in the Haystack
The QMS documentation can be impenetrable. How to outsmart the system? In many cases a simple document management system won’t even do the expected job.
Where Did the Time Go? - Poor Time Management
Good time management requires driving attention from activities to results: being busy isn’t the same as being effective.
Quality Manual or Workflow Processes? What should I establish first?
The Quality Manual requires many references to the applied company and the workflow processes. Synchronously, most quality management related references are advising to