qmsWrapper Blog - Take Back Compliance - The Art of Managing Through Quality
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...
CAPA Checklist - Step by Step Guide
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.
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.
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.
Cup of Joe 39# - Key factor during an audit–prepared employees
A successful audit relies on communication. So, preparation of employees in order to know exactly how to interact with the auditors when they arrive is one of the most important steps.
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!
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.
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.
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.
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.
Cup of Joe 33# - Revision History helps you with transferring to eQMS
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?
Gone! Audit Day Fears! How Cardio-Phoenix Took the Fear out of an ISO Audit With Help from qmsWrapper
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
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.
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...
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.
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.
