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What is Tricentis Vera?

Tricentis Vera transforms Digital Validation by not only adding electronic signatures to digital documents but also by innovating the Computer Systems Validation process, thereby removing tedious and redundant documentation practices while linking compliance to high-quality software standards. Through the implementation of triggers and controls that ensure electronic signatures meet 21 CFR Part 11 requirements within Agile software testing processes, companies can significantly accelerate their market entry with Tricentis Vera. Furthermore, Vera provides a cohesive interface across multiple tools, acting as a centralized system of record that enables real-time tracking of review and approval processes for users and teams. Once validation assets are submitted for approval or achieve the required endorsements, the records are securely locked in qTest and Jira, safeguarding them from any modifications during or after the approval process. This seamless integration not only fosters enhanced collaboration but also optimizes workflows, making certain that quality and compliance are upheld throughout the software development lifecycle. In addition, Tricentis Vera's capabilities empower organizations to streamline their validation efforts while ensuring adherence to regulatory standards.

What is OpenText Clinical Trial Quality Management?

In the past few years, the Life Sciences industry has faced fines and settlements totaling almost $15 billion due to compliance issues, highlighting the critical need for companies to adhere to best practices in pharmaceuticals, medical devices, and biotechnology. Furthermore, the management of clinical trials significantly impacts the duration, scope, and financial investments necessary for the advancement of drugs and medical devices. By leveraging OpenTextâ„¢ Clinical Trial Quality Management System (ctQMS), organizations can ensure compliance, reduce record-keeping costs, and promote collaboration to implement best practices throughout the clinical trial process. This strategic methodology not only boosts operational efficiency but also plays a vital role in the successful development of products. Ultimately, embracing such advanced systems can lead to more innovative solutions in the healthcare landscape.

Media

Media

No images available

Integrations Supported

Jira
Tosca
qTest

Integrations Supported

Jira
Tosca
qTest

API Availability

Has API

API Availability

Has API

Pricing Information

Pricing not provided.
Free Trial Offered?
Free Version

Pricing Information

Pricing not provided.
Free Trial Offered?
Free Version

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Company Facts

Organization Name

Tricentis

Date Founded

2007

Company Location

United States

Company Website

www.tricentis.com/products/digital-validation-vera/

Company Facts

Organization Name

OpenText

Date Founded

1991

Company Location

Canada

Company Website

www.opentext.com/info/clinical-trial-management

Categories and Features

Compliance

Archiving & Retention
Artificial Intelligence (AI)
Audit Management
Compliance Tracking
Controls Testing
Environmental Compliance
FDA Compliance
HIPAA Compliance
ISO Compliance
Incident Management
OSHA Compliance
Risk Management
Sarbanes-Oxley Compliance
Surveys & Feedback
Version Control
Workflow / Process Automation

Categories and Features

Clinical Trial Management

21 CFR Part 11 Compliance
Document Management
Electronic Data Capture
Enrollment Management
HIPAA Compliant
Monitoring
Patient Database
Recruiting Management
Scheduling
Study Planning

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