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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

THINQ stands out as a leading authority in compliance within the Life Sciences sector, offering tailored solutions to a diverse array of pharmaceutical, medical device, and biotechnology firms. With a distinct focus on validation, THINQ is at the forefront of revolutionizing validation management for Life Sciences organizations. The company provides extensive development and oversight of compliance programs, delivering powerful, proven solutions customized for each enterprise client. By transforming regulatory requirements into a strategic advantage, THINQ empowers organizations to thrive. In the current landscape of regulations, innovative companies recognize that compliance, risk management, and validation should not merely be managed but expertly mastered. Leveraging over 20 years of demonstrated compliance expertise, THINQ Compliance equips businesses with the tools to design and execute effective risk-management and compliance strategies. Participants can also enjoy the dynamic experience of compliance training sessions led by some of the industry's most insightful professionals, ensuring they remain at the cutting edge of compliance knowledge and practices.

API Access

Has API No 

API Access

Has API No 

Screenshots View All

Screenshots View All

Integrations

No details available.

Integrations

No details available.

Pricing Details

No price information available.
Free Trial No 
Free Version No 

Pricing Details

$20000.00/one-time
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 Yes 
Live Rep (24/7) No 
Online Support No 

Types of Training

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

Types of Training

Training Docs No 
Webinars No 
Live Training (Online) No 
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

THINQ Compliance

Founded

1994

Country

United States

Website

www.thinqcompliance.com

Product Features

Compliance

Archiving & Retention Yes 
Artificial Intelligence (AI) No 
Audit Management Yes 
Compliance Tracking No 
Controls Testing Yes 
Environmental Compliance Yes 
FDA Compliance Yes 
HIPAA Compliance Yes 
ISO Compliance Yes 
Incident Management No 
OSHA Compliance Yes 
Risk Management Yes 
Sarbanes-Oxley Compliance Yes 
Surveys & Feedback No 
Version Control Yes 
Workflow / Process Automation No 

EHS Management

Audit Management No 
Corrective / Preventive Actions No 
Environmental Management No 
Environmental Risk Assessment No 
Forms Management No 
Incident Management No 
Industrial Safety Management No 
Injury Reporting No 
Inspection Management No 
MSDS No 
OSHA Recordkeeping No 
Occupational Health Management No 
Safety Risk Assessment No 
Training Management No 
Waste Management No 

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