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What is Res_Q?

Res_Q is an AI-powered GxP electronic validation and compliance management platform developed by Sware for pharmaceutical, biotechnology, and other regulated life sciences organizations. The software provides a centralized cloud-based environment for managing computerized system validation activities throughout the application lifecycle. Its validation management capabilities support planning, documentation, risk assessments, test execution, approvals, change management, and ongoing compliance monitoring. Agentic AI functionality automates routine administrative tasks, tracks validation progress, and identifies activities requiring review or human judgment. Intelligent risk scoring evaluates system criticality and other relevant factors to help quality teams prioritize validation activities and allocate resources. The platform includes automated asset processing that organizes uploaded vendor documentation, validation packages, protocols, and other supporting materials into searchable records. Its video-to-script feature converts recordings of on-screen software processes into structured validation scripts to simplify test documentation. Smart dashboards and analytics provide visibility into validation workloads, operational milestones, risk levels, and compliance status across departments and facilities. Res_Q supports validation requirements associated with Good Clinical Practice, Good Laboratory Practice, Good Manufacturing Practice, and artificial intelligence systems used in regulated environments. Its AI validation capabilities include risk-based documentation, change tracking, and performance monitoring aligned with GAMP 5 guidance and applicable regulatory expectations. Through Res_Q Connect, the platform integrates with enterprise applications, quality systems, and automated testing tools using governed workflows, approval controls, and traceable audit records.

What is Agatha?

Agatha offers a wide array of cloud-based solutions meticulously tailored for the life sciences industry, which enables the centralized management of documents and processes associated with clinical operations, quality assurance, regulatory compliance, and training initiatives. This innovative platform is designed to support the unique workflows of biotech companies, pharmaceutical enterprises, medical device producers, and contract research organizations, providing various modules such as eTMF (Inspection-Ready Master Trial File), Remote ISF (Investigator Site File) management, and tools for developing and approving standard operating procedures (SOPs), in addition to managing quality documents for CAPAs, deviations, and change controls. Furthermore, Agatha streamlines the handling of regulatory documents, ensuring the seamless creation, review, approval, storage, and sharing of materials within an integrated system. By advocating for a paperless environment, it reduces administrative burdens and enhances data security, all while being built on a framework that adheres to global compliance standards like 21 CFR Part 11, GDPR, and EU Annex 11. Ultimately, Agatha equips life sciences organizations with the tools necessary to refine their operations and uphold adherence to industry regulations more effectively, paving the way for improved efficiency and innovation in the sector. With its robust features, the platform not only simplifies complex processes but also supports organizations in achieving their strategic goals.

Media

Media

Integrations Supported

Adobe Acrobat Sign
Amazon Web Services (AWS)
Benchling
Box
Docusign
LabVantage
LabWare LIMS
MasterControl
Microsoft Dynamics 365
NetSuite
Nuvolo
Okta
OpenClinica
SAP Cloud Platform
ServiceNow
Smartsheet
TraceLink
TrackWise
Veeva CRM
ZenQMS

Integrations Supported

API Availability

Has API

API Availability

Pricing Information

Pricing not provided

Pricing Information

Pricing not provided

Supported Platforms

SaaS

Supported Platforms

SaaS

Customer Service / Support

Web-Based Support

Customer Service / Support

24 Hour Support
Web-Based Support

Training Options

Documentation Hub
Webinars
Online Training

Training Options

Documentation Hub
Online Training

Company Facts

Organization Name

Sware

Date Founded

2015

Company Location

United States

Company Website

www.sware.com/products/res_q

Company Facts

Organization Name

Agatha

Date Founded

2015

Company Location

United States

Company Website

en.agathalife.com

Categories and Features

Life Sciences

Not specified

Categories and Features

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