Document Management & Control
for achieving and maintaining ISO 13485:2016, CE Mark or U.S.QSR (21CFR 820) for 510(K) Compliance Success
Secure Cloud Document Management System
- The easiest and the most understandable way for users to manage and control their project, QMS, and compliance documentation.
- qmsWrapper Document Management System is designed to support compliance, it includes version control, detailed file histories, file tracking, source tagging, comments, authority control.
- qmsWrapper Document Management and Contol System is mirrored in the QMS module. It is integrated and interconnected with all other modules in qmsWrapper, and with workflow and processes that drive the team.
qmsWrapper integrates and interconnects
seven business modules including:
- Project Management
- Quality Management
- Risk Management
- Document Management
- Team Collaboration
- Forms and Form Editor
- Traceability Matrix
Each of these modules mirrors the structure of the other,
making the system easy for the users to understand, and use.
User-friendly and team focused Document Management System that works for you, not you for it!
Cloud Access - from any device, any time
- easy and accessible
- on demand scalability
- secure and fast access
Design History Files (DHF)
- allows users to securely store their own private documents.
Document Compliance System
qmsWrapper Document Management System is designed to
support compliance it includes:
- version control
- detailed file histories
- file tracking
- source tagging
- authority control
Electronic trail and Document Control
Track, store and control documents to prove compliance
- Audit trail
- Change control
- Security file locking
Paperless Office - Keeping your documentation neat and tidy
Project members store files directly into the project they are working on.
There are 5 Root Document Storage Options:
- Project folder:
Store files directly into the project folders.
- Documents Folder:
Securely store your own private documents.
- QMS Folder:
Contains all the QMS compliance documents for that project.
The QMS Folder is mirrored both in the QMS module and the DMC.
QMS documentation is generated through a QMS process or a QMS Event.
- Trash Control
Compliance requires that users not be allowed to simply delete files at will. A trash control feature allows project managers and admins to set deletion policies on stored files, for both private and project documents, separately.
- Library folder
The classic central library. Perfect for keeping ISO standards, specifications or any type of formal document that needs to be accessible by everyone in the company. They are highly controlled, either by project or company-wide.
Easily find a needle in the haystack!
Any document can be listed and filtered by any parameters,
including the search for documents related to specific processes,
projects, sub-projects, tags, type of documents, etc.,
search results can be printed if required.
How to securely store and protect your Business Data and Compliance Documentation with qmsWrapper
A complete document compliance system.
DMC includes all the high-end features
you’d expect of a comprehensive DMC system required
to support compliance, including version control,
detailed file histories, File tracking, source, tagging,
comments and authority control.
- Lock and store qmQMS approved files in the secure vault
ensuring the integrity of your QMS compliance is never compromised.
Document Approval Workflow
- Allows only specific users to review and approve documents.
- Approvals are automatically documented with full approval history
QMS PIN signatures
- Use secure, unique PIN to safely approve documentation, without the risk of the inside or outside breaches.
Centralized Cloud Storage
- All your documents are saved in one place - secured centralized storage
- Only authorized users are allowed to access particular tasks, projects, files and documentation
qmsWrapper – a comprehensive and understandable DMC system.
Making compliance easier for teams.