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Experience the Power of qmsWrapper with Use Cases from
the Real World - Our Subject Matter Experts Walk You Through
Step-by-Step Guides on Organizing and Updating QMS Documentation,
Implementing Design Controls in the Traceability Matrix, Conducting
Risk Assessments, and Much More.
Discover qmsWrapper's Full Potential for Effectively Setting Up and Managing Your QMS.
Discover Today How qmsWrapper Simplifies Compliance!
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.
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...