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).

Quality Management is a core asset

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

Discover GxP Suite

GxP Suite is a solution that currently has the following modules. Discover more about each one.

Digitize your business. Avoid paperwork and complex processes.
Optimize your resources. Save time and money.
No more content duplication.
Better content tracking.

Seemlessy manage your GxP processes and Compliance Documented Information to FDA 21 CFR Part 11 with.

GxP Information Management System

Manage Content and Records Lifecycle.
Unify Creation, Renewal, New Version and Obsoletion workflows.
Improve productivity and adoption with user activity dashboard.
Automate Periodic Review and Document Change Ordeer activities.
Enable collaboration with Open Text Brava.
Control training excution ( stand alone or integrated with eLMS).
Paperless Batch Production Records process ( integrated with SAP PP).
Govern the Quality Management System with preconfigured KPIs.
Simply manteinance with Business User administration tools.
Accelerate application validation ( OQ, PQ, IQ)

Discover GxP Suit

Electronic Trial master File Management System

Easily transition to a digital Clinical Trial process with

Electronic Trial Master File Management System

Comply with DIA reference model (v2.0 and v3.0).
Track TMF evolution between clinical phases.
Provide secure external collaboration features for CRO’s or other 3rd parties.
Govern TMF timeness and completeness.
Locate and distribute content based on text or trial classification data.
Enable collaboration with OpenText Brava®.
Manage TMF data, content and milestones in one application.
Unify Products, Countries and Sites management to share between Trials.
Quality control workflow for review and approval of content.

GxP Information Management System

Electronic Common Technical Document Management System

Accelerate your product global Submission process with

Electronic Common Technical Document Management System

Comply with eCTD reference model (FDA, EMA, CFDA, MHLW, free).
Track sequence submission per country.
Control eCTD completeness before submission.
Provide single source of content to e-submission publishing applications (Extedo and Lorenz).
Reuse content between sequences without duplication.
Enable collaboration between Regulatory Affairs and other departments.
Govern submission status with reporting dashboard.
Quality control workflow for review and approval of content.
Provide secure external contribution features for 3rd parties.
Store communications with health authorities.

Electronic Trial master File Management System

Quality Event Management System

Ensure trazability and control to your complete QA-CAPA activities with

Quality Event Management System

Manage Claims, QA Non Conformities and Deviations.
Measure CAPA performance based on industry standard KPIs.
Accelerate collaboration between QA and other departments for event discovery.
Link event content to business objects (Material, Customer, Delivery Note,..).
Audit event discovery activities and event closure.
Unify internal and external event communication activities.
Extended event creation and follow up via mobile app.
Reference business data to provide QA-CAPA corporate dashboard.
Accelerate application validation (OQ, PQ, IQ).

Electronic Common Technical Document Management System

Discover GxP Suite

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.

Contact us to know more about GxP

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