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It's everything you'll need for your FDA and CE mark submission.
QMS PROCESSES + PROCESS EDITOR
• Drive out mistakes, and automatically track compliance needs and issues through projects
• Modify, edit or create new QMS Processes to meet your own particular needs.
TRACEABILITY MATRIX, FDA 510K & CE MARK
Track, manage and organize all your CE Technical Files and FDA Device History Files in a fully integrated Traceability Matrix.
RISK MANAGEMENT, ISO 14971
Identify, evaluate and mitigate risks through the single matrix interface! With complete risk assessment, effective throughout your product’s entire lifecycle.
DOCUMENT MANAGEMENT & VERSION CONTROL & SOPs, DHFs
Robust, comprehensive and automated Document Management for anybody who really hates paperwork!
Secure, internal team messaging.
BALANCE RESOURCES & TRACK PERFORMANCE IN REAL-TIME
Transparent issue tracking, transparent audit trail. Activity dashboards and real-time reports help to better organize projects, assign the right work to the right team, with the right schedule, and recalibrate work and team members when necessary to utilize resources more effectively.
Role-Based permissions + Flexible workgroups and customizable roles for each project.
ELECTRONIC SIGNATURES, FDA QSR 21 PART 11
21st CENTURY QMS, WORKS “RIGHT-OUT-OF-THE-BOX”
Whether an accidental Quality Manager or a seasoned professional easily step into the role and effectively organize a productive compliance savvy team. Get started in 10 minutes!
Don’t use separate software apps for handling projects, QMS, and team communication. Save money, eliminate compatibility issues and keep the focus by not having to switch between apps.
VALIDATION FOR USE DOCUMENTATION SET
QUALITY MANUAL + GAP REPORT
25 Users + 1GB Storage
$995,00 per year
Additional Storage possible up to 500GB.
1GB per $18,00.
Subscription that costs between $83 and $832. Price may vary depending on commitment and so on.
21cfr11 21cfr820 business-process business-process-management cemark compliance compliance-audit compliance-software compliance-tracking document-management euannex11 iso13485 iso14971 medical-health medical-research process-management project-collaboration project-management project-planning project-tracking qms quality-control quality-management risk risk-analysis risk-and-compliance risk-assessment risk-management risk-mitigation risks-management secure-messaging team-communication team-management
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Hello, we are using qmsWrapper less then a year and we are more than satisfied with this software. Managing documents is now easier then before and I love how they made Tractability Matrix. The most...See why people like qmsWrapper 😍 Post your review
we are using qmsWrapper less then a year and we are more than satisfied with this software.
Managing documents is now easier then before and I love how they made Tractability Matrix.
The most important is that they have the best support team.
I am a current user of this product and I have to say that it helped my company to be in compliance with CEMark and ISO 13485. The features this software has, are second to none. I´ve tried a couple of qms software before qmsWrapper and honestly, I couldn´t be happier. It cost less than the others and it gives you a performance that has no comparison.