Efficiently communicate within your team using qmsWrapper’s Team Messaging module. Engage in one-on-one chats, group chats, or topic-based discussions, with the ability to send messages, attachments, schedule meetings, etc.
Understand the process approach in qmsWrapper and how it supports QMS standards. Learn about processes, tasks, and flowcharts to effectively manage workflows. Create and customize processes, use advanced actions, and track progress through the Process Engine.
Efficiently manage your work with qmsWrapper’s Dashboard. Access your current events, adjust your profile, receive notifications, and navigate through different modules using the Toggle Sidebar.
In a medical device quality system, who can view, edit, approve, and sign records is a regulated decision, not just an IT setting. FDA 21 CFR Part 11 expects access limited to authorised individuals and an audit trail that attributes every action to a real…
In this guide, users will learn how to set up and personalize their profiles in qmsWrapper. They will discover how to access profile settings, manage their status, download the desktop app, and customize preferences such as display, notifications, and more.
qmsWrapper can be wrapped around Jira. This extends the benefits of Jira in the medical device world. The medical device startups and small businesses that use Jira can be linked to qmsWrapper.
Setting up a QMS for medical device development is not a single project decision. It is a sequence. ISO 13485:2016, FDA 21 CFR Part 820, and EU MDR Article 10 all expect the same baseline before product work begins: a defined scope, documented processes, controlled…
A form is a document with a fixed arrangement of input fields, designed for entering, extracting, or communicating the required information. In qmsWrapper, there are: General Forms, Custom Forms, and Matrix forms.
Document management is where a medical device quality system either stays audit-ready or slowly falls apart. ISO 13485:2016 Clause 4.2.3 requires controlled documents, Clause 4.2.4 requires controlled records, FDA 21 CFR Part 820.40 sets the same expectation for document controls, and EU MDR technical documentation…
Do remote audits becoming ‘new normal’? What are the benefits of remote auditing and what are their limitations? About all that and more, you can find out in our whitepaper.
