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Document Management & Control
with qmsWrapper

for achieving and maintaining ISO 13485:2016, CE Mark or U.S.QSR (21CFR 820) for 510(K) Compliance Success

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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 five main business modules

qmsWrapper integrates and interconnects
seven business modules including:

Each of these modules mirrors the structure of the other,
making the system easy for the users to understand, and use. 

Project members store files directly into the project they are working on.

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
  • comments
  • authority control

Electronic trail and Document Control

Track, store and control documents to prove compliance

  • Versioning
  • Tagging
  • Stamps
  • Audit trail
  • Change control
  • Security file locking
  • Permissions 

 

 

Access to files can be done in two ways, directly through the web storage module, or locally through WrapperApp.

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:

  1. Project folder:

Store files directly into the project folders.

  1. Documents Folder:

Securely store your own private documents.

  1. 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.

  1. 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.

  1. 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.

Access files two ways.

Access to files can be done in two ways, directly through the web storage module, or locally through WrapperApp.

WrapperApp is a desktop module for syncing files directly into Project Storage.

 

WrapperApp™ is a powerful desktop document control app
that allows you to work locally and sync with the Central Document Storage. 

  • This is not simple file sharing; this is project based sharing where the WrapperApp
    displays the projects you have permissions to on your desktop for easy access.

The WrapperApp is similar to Google Drive™, Dropbox™, and OneDrive™,
the differences are that the WrapperApp™

–shares and shows your project files on your desktop

–stores project files directly into Project Storage

  •  No need to go through the Central Storage, it’s already on your desktop.
  • Allows users to share and share project files with other project members.
  • It’s available for Windows, iOS & Linux. (Java required)
Wrapper App

 

 

Files in Chat, remain under DMC control.

Advanced Document Search

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.
 

QMS Vault

  • Lock and store qmQMS approved files in 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
A complete document compliance system.

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

Role-based security

  • 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.

 

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