Showing posts tagged with: eQMS

A library is an integral part of any community. They provide information and resources. So why not one in qmsWrapper, more than storage it’s a favorite place to keep important documents that need to be accessed by all. For example, standards, marketing documents, graphics used by all… endless reasons really. It’s the one easy-access place to...

When implementing and maintain ISO standards 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 guaranteed successful business. There are few reasons for choosing an eQMS over...

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? But...

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...

One of the main criteria for an eQMS is to have implemented an electronic signature. Much 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...

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...

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? You just need to upload the latest version without the number of that version (for example “Technical file”) and make a note in the file...