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Average Ratings 0 Ratings

Total
ease
features
design
support

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Write a Review

Description

Kalypso offers a budget-friendly solution for life sciences organizations looking to implement a Regulatory Information Management (RIM) system, known as Accel for RIM. This platform facilitates an integrated approach to effectively oversee and monitor product registrations while enhancing the accuracy of submissions and managing global Unique Device Identification (UDI) information, thereby streamlining product distribution. It also merges compliance and quality data from multiple enterprise systems into a comprehensive source of truth for product registrations and tracking, which expedites regulatory submissions. Utilizing modern APIs, it aggregates product data along with necessary regulatory documentation and submission packages. The system is pre-configured for swift deployment and is built on a validated software framework, grounded in the best practices and successful implementations within the industry. By adopting this solution, companies can expect not only efficiency but also a significant reduction in time spent on regulatory tasks.

Description

Res_Q is an AI-powered electronic validation platform designed to help life sciences organizations manage computerized system validation and regulatory compliance. Developed by Sware, the cloud-based software centralizes validation planning, documentation, execution, approvals, and ongoing lifecycle management. Its agentic AI capabilities automate administrative activities, monitor validation progress, and identify milestones that require review or intervention. Intelligent risk assessment tools evaluate system criticality to prioritize validation workloads and support risk-based compliance strategies. The platform includes automated document processing that converts uploaded validation materials, vendor manuals, and supporting records into organized, searchable information. Its video-to-script functionality transforms recorded software processes into structured validation test scripts. Smart dashboards provide visibility into validation status, operational performance, outstanding tasks, and compliance activities across multiple systems and locations. Res_Q supports GCP, GLP, GMP, and AI validation workflows, including risk-based documentation and change management aligned with GAMP 5 principles. Through Res_Q Connect, organizations can integrate applications such as Jira and ServiceNow, coordinate automated testing, and maintain audit trails across connected systems.

API Access

Has API No 

API Access

Has API Yes 

Screenshots View All

Screenshots View All

Integrations

Adobe Acrobat Sign No 
Amazon Web Services (AWS) No 
Benchling No 
Box No 
Docusign No 
LabVantage No 
LabWare LIMS No 
MasterControl No 
Microsoft Dynamics 365 No 
NetSuite No 
Nuvolo No 
Okta No 
OpenClinica No 
SAP Cloud Platform No 
ServiceNow No 
Smartsheet No 
TraceLink No 
TrackWise No 
Veeva CRM No 
ZenQMS No 

Integrations

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

Pricing Details

No price information available.
Free Trial No 
Free Version No 

Pricing Details

No price information available.
Free Trial No 
Free Version No 

Deployment

Web-Based Yes 
On-Premises No 
iPhone App No 
iPad App No 
Android App No 
Windows No 
Mac No 
Linux No 
Chromebook No 

Deployment

Web-Based Yes 
On-Premises No 
iPhone App No 
iPad App No 
Android App No 
Windows No 
Mac No 
Linux No 
Chromebook No 

Customer Support

Business Hours No 
Live Rep (24/7) No 
Online Support Yes 

Customer Support

Business Hours No 
Live Rep (24/7) No 
Online Support Yes 

Types of Training

Training Docs No 
Webinars No 
Live Training (Online) No 
In Person No 

Types of Training

Training Docs Yes 
Webinars Yes 
Live Training (Online) Yes 
In Person No 

Vendor Details

Company Name

Kalypso

Founded

2004

Country

United States

Website

kalypso.com/industries/life-sciences/digital-regulatory-information-management/

Vendor Details

Company Name

Sware

Founded

2015

Country

United States

Website

www.sware.com/products/res_q

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