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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 Qualitum?

Qualitum is a cutting-edge platform specifically crafted for computer system validation (CSV/CQV) within the regulated life sciences industry. It automates the generation of IQ/OQ/PQ protocols, GAMP 5 classifications, and audit trails directly from primary documents like URS, P&IDs, and SOP libraries, ensuring thorough tracking of requirements through a queryable graph that replaces the need for traditional spreadsheet RTMs. The platform is committed to upholding stringent ALCOA+ data integrity standards by monitoring every record rather than just samples and enabling human reviewers to validate and approve the outputs generated by its agent. Qualitum functions on a single-tenant basis across AWS, Azure, or on-premises setups, providing customers with control over their keys and preventing any training rights on their data. Its ability to integrate smoothly with existing systems of record such as Veeva, MasterControl, TrackWise, and AVEVA PI makes it an adaptable option for various organizations. Tailored to meet the demands of Heads of Validation and validation consultancies, it supports stakeholders in the pharmaceutical, biotechnology, and medical device sectors. Prospective clients can request a per-site annual license quote, and there is also a fixed-fee pilot program available for 8-12 weeks for a single system, allowing for an introductory experience. This well-rounded approach ensures that companies can efficiently reach their validation objectives while remaining compliant in an increasingly regulated landscape, enhancing the overall effectiveness of their operations.

Media

Media

No images available

Integrations Supported

Jira
Tricentis Tosca
qTest

Integrations Supported

API Availability

API Availability

Pricing Information

Pricing not provided

Pricing Information

Pricing not provided

Supported Platforms

SaaS

Supported Platforms

SaaS
On-Prem

Customer Service / Support

Web-Based Support

Customer Service / Support

Not specified

Training Options

Documentation Hub
Webinars
Online Training

Training Options

Not specified

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

Qualitum

Company Website

qualitum.ai

Categories and Features

Compliance

Not specified

Life Sciences

Not specified

Categories and Features

Life Sciences

Not specified

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