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Description
Govalidation is an innovative web application that streamlines the validation life cycle by digitizing the entire process. It features a customizable workflow that automates the review and approval cycles efficiently. Designed to adhere to 21 CFR part 11 and regulatory standards, the system incorporates insights from industry professionals and follows leading best practices. It supports a systematic approach to method validation, utilizing a risk-based strategy for each User Requirement Specification (URS) while facilitating the development of mitigation plans and test cases to address identified risks. By transitioning to digital platforms, it entirely eliminates paper records, ensuring a paperless testing environment with integrated deviation management capabilities. This transformation significantly reduces the likelihood of manual errors. The platform also offers enhanced visibility into the execution of validation projects, providing detailed insights into project status in real-time. Additionally, the system is audit-ready, equipped with up-to-date data for thorough review and compliance verification, thus enhancing the overall integrity of the validation process. With Govalidation, organizations can achieve greater efficiency and accuracy while navigating complex regulatory landscapes.
Description
Efficiently generating reports for NGS-based clinical tests necessitates a well-established and sophisticated platform that can automatically prioritize variants, interpret clinical data, and create comprehensive reports. Strand Omics serves as a rapid, HIPAA-compliant cloud platform that enhances our clinical diagnostics efforts, having been refined over four years through the analysis of more than 10,000 clinical reports and numerous peer-reviewed studies. This platform integrates advanced bioinformatics algorithms with curated databases, intuitive visualization tools, and robust reporting features. It is designed with specialized workflows tailored for both rare inherited conditions and somatic tumor profiling assays. Additionally, the system boasts a library of over 10,000 somatic variants that have been curated for their oncogenic potential, alongside 100 genes selected for their druggability across various cancer types, as well as 500 drugs that have been validated for efficacy against multiple cancers. Furthermore, its comprehensive approach ensures that healthcare professionals have access to critical data, ultimately facilitating informed decision-making in patient care.
API Access
Has API
API Access
Has API
Integrations
No details available.
Integrations
No details available.
Pricing Details
No price information available.
Free Trial
Free Version
Pricing Details
No price information available.
Free Trial
Free Version
Deployment
Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook
Deployment
Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook
Customer Support
Business Hours
Live Rep (24/7)
Online Support
Customer Support
Business Hours
Live Rep (24/7)
Online Support
Types of Training
Training Docs
Webinars
Live Training (Online)
In Person
Types of Training
Training Docs
Webinars
Live Training (Online)
In Person
Vendor Details
Company Name
AdventSys Technologies
Founded
2010
Country
India
Website
www.govalidation.com/paperless-validation
Vendor Details
Company Name
Strand Life Sciences
Founded
2000
Country
India
Website
strandls.com/bioinformatics/
Product Features
Scientific Data Management System (SDMS)
Analytics
Artificial Intelligence (AI)
Audit
Centralized Data Repository
Collaboration
Compliance
Data Security
ELN Integration
LIMS Integration
Workflows
Product Features
Scientific Data Management System (SDMS)
Analytics
Artificial Intelligence (AI)
Audit
Centralized Data Repository
Collaboration
Compliance
Data Security
ELN Integration
LIMS Integration
Workflows