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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 Kivo?

Kivo presents a groundbreaking solution tailored for sponsors and CROs by offering an affordable document and process management platform that empowers life sciences teams to effectively execute their responsibilities in a cohesive, user-friendly, and compliant setting. By combining functionalities such as DMS, RIM, QMS, eTMF, and eCTD, Kivo enables professionals in the pharmaceutical, biotechnology, medical device, and biologics sectors to manage regulated documentation, quality assurance tasks, clinical trial records, regulatory submissions, and workflow processes seamlessly, eliminating the complications associated with juggling multiple disconnected tools. With its Document Management System, Kivo allows users to oversee controlled documents and automate workflows, ensuring project monitoring, corporate documentation management, and due diligence preparedness in a streamlined manner through features like version control, collaborative tools, audit trails, robust search capabilities, workflow automation, and Part 11-compliant electronic signatures. Furthermore, the RIM component significantly enhances project oversight and communication, simplifies submission construction and publishing transitions, offers eCTD viewing alternatives, and optimizes dossier management and interactions with regulatory bodies. Overall, Kivo equips life sciences teams with essential tools that ensure compliance and boost operational efficiency, ultimately leading to improved project outcomes and a more organized workflow. This comprehensive approach not only addresses current challenges but also prepares organizations for future demands in the rapidly evolving life sciences landscape.

Media

Media

Integrations Supported

Docusign
Adobe Acrobat Sign
Benchling
LabWare LIMS
MasterControl
Microsoft Dynamics 365
NetSuite
Nuvolo
Okta
OpenClinica
SAP Cloud Platform
ServiceNow
Smartsheet
TrackWise
Veeva CRM
ZenQMS

Integrations Supported

Docusign
Jama Connect
Jira
Microsoft Excel
Microsoft Word

API Availability

Has API

API Availability

Has API

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

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

Kivo

Date Founded

2021

Company Location

United States

Company Website

kivo.io

Categories and Features

Life Sciences

Not specified

Categories and Features

Document Management

Access Controls
Archiving & Retention
Collaboration Tools
Compliance Tracking
Document Archiving
Document Assembly
Document Capture
Document Conversion
Document Delivery
Document Indexing
Document Retention
Electronic Signature
Email Management
File Recovery
File Type Conversion
Forms Management
Full Text Search
Offline Access
Print Management
Version Control

Life Sciences

Not specified

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