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What is Veeva SiteVault?

Improve the efficiency of regulatory operations within your organization to strengthen compliance and promote research progress. Veeva SiteVault streamlines the management of clinical trials by consolidating regulatory responsibilities, resulting in heightened effectiveness and adherence to necessary regulations. You can manage regulatory and source documents through a single platform that meets 21 CFR Part 11 and HIPAA requirements. With real-time data across all trials, SiteVault Enterprise enhances operational performance, speeds up study initiation, and supports rapid, high-quality trial management. Move away from manual processes and personalize your workflows to improve both quality and speed in study activation. By providing monitors with secure, direct access to your regulatory and source documents, you eliminate the complications associated with EMR access and document redaction. Additionally, you can customize your workflows, create reports, and develop dashboards that offer valuable insights into start-up timelines and regulatory processes, ultimately driving improved results for your clinical trials. This holistic strategy not only simplifies processes but also fosters greater collaboration among teams, enabling better communication and efficiency throughout the trial phases. As a result, your organization can achieve its research goals while maintaining rigorous compliance standards.

What is Govalidation?

Govalidation is a cutting-edge web application that optimizes the validation life cycle by converting the entire process into a digital format. It boasts a customizable workflow that effectively automates the review and approval processes. Designed to comply with 21 CFR part 11 and relevant regulatory frameworks, the application integrates expertise from industry leaders and adheres to recognized best practices. It promotes a structured method validation approach by employing a risk-based strategy for every User Requirement Specification (URS) and supports the creation of mitigation plans and test cases to tackle any identified risks. By moving to a digital solution, it entirely removes the need for paper documentation, fostering a completely paperless testing environment equipped with integrated deviation management features. This shift significantly minimizes the potential for manual errors, enhancing overall reliability. The platform also provides improved visibility into the progress of validation projects, allowing users to access real-time insights into project status. Furthermore, the system is designed to be audit-ready, containing up-to-date information for comprehensive reviews and compliance checks, thereby bolstering the integrity of the validation procedure. Beyond these features, Govalidation empowers organizations to navigate intricate regulatory landscapes with enhanced efficiency and precision, ensuring they meet industry standards effectively.

Media

Media

Integrations Supported

Microsoft 365

Integrations Supported

Microsoft 365

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

Veeva Systems

Company Location

United States

Company Website

sites.veeva.com/products/sitevault-enterprise/

Company Facts

Organization Name

AdventSys Technologies

Date Founded

2010

Company Location

India

Company Website

www.govalidation.com/paperless-validation

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

Scientific Data Management System (SDMS)

Analytics
Artificial Intelligence (AI)
Audit
Centralized Data Repository
Collaboration
Compliance
Data Security
ELN Integration
LIMS Integration
Workflows

Categories and Features

Scientific Data Management System (SDMS)

Analytics
Artificial Intelligence (AI)
Audit
Centralized Data Repository
Collaboration
Compliance
Data Security
ELN Integration
LIMS Integration
Workflows

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