FORMS + FORM EDITOR • Use any of the many forms that are FDA and CE Mark Ready. • Attach any form to any task or any process and capture data as it is inputted. • Create, edit and customize your own forms. You can even make them pretty. 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!

TEAM MESSAGING Secure, internal team messaging. BALANCE RESOURCES & TRACK PERFORMANCE IN REAL-TIME Transparent issue tracking, transparent audit trail. Activity dashboards and real-time reports helps 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! INTEGRATED, ALL-IN-ONE 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.

Add-ons: VALIDATION FOR USE DOCUMENTATION SET, QUALITY MANUAL +GAP REPORT