qmsWrapper Blog

During the audit process, CAPA is always in the center of attention, and auditors are very strict when it comes to it. Also, failure to stick to proper corrective and preventive actions is considered a violation of regulations on good manufacturing practices.

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.

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.

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.

It's one thing to become ISO certified, but maintaining the certification is another thing with all the updates and new records.

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.

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!

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.

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.

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.

Most of the startups and small companies have a problem with organizing folders, especially if they are still using a paper-based QMS.

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?

We offer innovative products and services. If you need assistance, let it be tips, tricks, QMS DIY techniques, Quality Issues or regulatory advice, your matter will be handled properly.

There are countless benefits to implement a quality management system. Think of the investment in modern QMS software as an investment in preventing quality issues.

The power of trade shows is impressive. From showcasing your newest products, to expand your customer base, close sales, keep an eye on your competition, expand your distributor network, meet face to face with your remote customers, etc.

The Traceability Matrix in qmsWrapper™ is fully integrated into the project and quality management.

Read about how Medical device startup "Cardio-Phoenix" successfully carried out the audit with help of qmsWrapper.

It’s a cloud-based development and compliance management software, in layman’s terms, a QMS and Project management system specifically designed for medical device companies, including start-ups.

The Traceability Matrix in qmsWrapper™ is fully integrated into the project and quality management. Map and Trace the design control relationships for your medical device.

Improve Customer Retention and Ensure That You Keep the Finger on the Pulse. Joe will guide you through ISO compliance

This article includes what is a QM, and what should include, Common mistakes & how to avoid them, Pro tips & best practices on how to do it right ...

Smart companies invest in the development of their employees. QMS Joe will guide you with handy tips & tricks to streamline your way to compliance.

By equipping employees with the tools and knowledge to perform their jobs, you can expect better performance and a more cohesive workplace.

The quality manual covers almost everything that company and its employees need to know about the ISO standards and what is expected of your quality management system.

Learn more about pitfalls, what you should do and benefits of establishing the Validation for Intended Use Documentation