Quality Game

WHY

Quality Management is a core asset

For FDA Regulated organizations, applications used for Quality Management and Quality Assurance are business critical assets, that’s why quality is in the center of their transformation inniciatives to mature into Quality Driven organizations.

In our 20+ years of experience, we have help FDA regulated organizations to leverage their core technology investments to grow their business and remain totally compliant with industry standards and regulations, like FDA 21CFR Part 11, Internation Standarization Organization (ISO), General Data Protection Regulation (GDPR), Advanced Track and Trace (ATT) or Medical Device Regulation (MDR).

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FEATURES

Our GxP Suite

GxP Suite by Stratesys leverages the OpenText Enterprise Information Management platform to help Quality Driven organizations automate and transform their Quality processes, remaining compliant with industry standards and regulations.

Our solution has been engineered by following this 4 principles:

User Centric Application

Task oriented interface to guide the user through his workload

Multi Device, Multi access

Simplify User Adoption

Agile Deployment

Simplify Implementation

Provide High Value Out of the Box Functionality

Security Model
Flexible Classification
Automated Workflows
Document Types
Reporting
Full Audit Trail

STRATESYS & OPENTEXT

Business Value Added on the top of OpenText Content Server

GxP Suite by Stratesys leverages the OpenText Enterprise Information Management platform to help FDA regulated organizations automate their Quality processes and comply with industry standards and procedures.

GxP info
GxP info

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