In a constant changing environment, we help organizations improve their quality related processes by driving innovation based on the last generation technology and industry best practices, while remaining complaint with market standards and regulations.

Providing efficient tools to reduce the impact that changes in WORKFORCE and PRODUCTS have in day-to-day business operations, so that quality driven organizations can adapt faster.

Providing new tools to the business to face the challenges derived from changes in REGULATIONS and MARKETS, so that quality driven organizations can grow faster.

In a constant changing environment, we help organizations improve their quality related processes by driving innovation based on the last generation technology and industry best practices, while remaining complaint with market standards and regulations.

Providing efficient tools to reduce the impact that changes in WORKFORCE and PRODUCTS have in day-to-day business operations, so that quality driven organizations can adapt faster.

Providing new tools to the business to face the challenges derived from changes in REGULATIONS and MARKETS, so that quality driven organizations can grow faster.

ABOUT US

Ensure regulatory compliance and turn it into a competitive advantage thanks to GxP Suite and its four modules that cover all parts of your quality processes.

ELECTRONIC LABORATORY NOTEBOOK MANAGEMENT SYSTEM
ELECTRONIC TRIAL MASTER FILE MANAGEMENT SYSTEM
GXP INFORMATION MANAGEMENT SYSTEM
ELECTRONIC COMMON TECHNICAL DOCUMENT MANAGEMENT SYSTEM
QUALITY EVENT MANAGEMENT SYSTEM

Quality Management is a core asset

In our 20+ years of experience, we have help Quality driven organizations to leverage their core technology investments to grow their business and remain compliant with industry standards and regulations.

Quality Management and Quality Assurance are business critical assets to reduce time to market, increase productivity and ensure quality in a constant change environment.

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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).

Our GxP Suite

Our solution has been engineered following this 4 principles:

User Centric Application

Task oriented interface to guide the user through his workload

Provide High Value Out of the Box Functionality

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

Multi Device, Multi access

Simplify User Adoption

Agile Deployment

Simplify Implementation

Discover GxP Suite

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

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Electronic Laboratory Notebook Management System

Unify your laboratory data in a single secure, efficient and collaborative repository through

Electronic Laboratory Notebook Management System

Share information and collaborate safely.
Gather information in an organized way.
Reuse data from paper to digital model.
Simplify the governance model for documentation.
Increase control over the state of the experiment.
Eliminate existing information silos between the R&D department and the rest of the departments.

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Previous product Gxp

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Electronic Trial master File Management System

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GxP Information

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.

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Electronic Laboratory Notebook Management System

Gpx Information Management System

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GxP Information

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)

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Electronic Trial master File Management System

Electronic Common Technical Document Management System

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GxP Information

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.

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GxP Information Management System

Quality Event Management System

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GxP Information

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).

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Electronic Common Technical Document Management System

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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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