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What is SmartSolve eQMS?

Simplify monotonous and repetitive activities to allow more focus on delivering products that enhance safety and efficacy, while also increasing speed. IQVIA’s SmartSolve Postmarket Surveillance provides a robust SaaS solution tailored for postmarket surveillance (PMS), offering you best practices for the centralized oversight of all PMS operations. The Fusion event is designed for SmartSolve and RIM Smart users, delivering in-depth education on relevant quality and regulatory topics, along with actionable insights and useful tools that can be utilized within any Life Sciences organization. Originally initiated as a live conference for SmartSolve users, Fusion has evolved over time to include both virtual and in-person sessions for the wider SmartSolve and RIM Smart communities. By adopting the IQVIA SmartSolve™ Regulatory Connector, you can significantly improve your compliance response times, accuracy, predictive planning, and overall operational efficiency. This Connected Intelligence framework exemplifies our innovative, integrated approach aimed at achieving substantial operational improvements for your organization, leading to a multitude of benefits. Keeping pace with these advancements is crucial for ensuring your organization stays relevant and competitive in an ever-changing industry landscape. Such proactive measures will not only enhance your current operations but also position your organization for future success.

What is Flinn?

Flinn functions as an AI-driven solution aimed at improving and simplifying the regulatory and quality management processes within the medical device (MedTech) industry. By enabling manufacturers to integrate artificial intelligence into complex and repetitive tasks like post-market surveillance, literature reviews, complaint handling, and safety database oversight, it substantially reduces the manual effort required and aids in maintaining compliance with regulations such as the EU Medical Device Regulation (MDR). The platform aggregates data from diverse sources, employs machine learning methods to detect patterns and assess potential risks, generates automated reports that align with regulatory requirements, and supports the rapid launch and management of high-quality products on a broader scale. As a result, organizations can achieve process efficiency improvements by as much as ten times, all while ensuring the auditability, transparency, and traceability of their compliance efforts. This cutting-edge approach not only optimizes operations but also encourages companies to prioritize innovation and quality in their offerings, ultimately contributing to a more robust and dynamic MedTech landscape. By harnessing these advanced capabilities, businesses can stay ahead in an ever-evolving regulatory environment.

Media

Media

Integrations Supported

Indent

Integrations Supported

API Availability

API Availability

Pricing Information

$542 one-time payment

Pricing Information

Pricing not provided

Supported Platforms

SaaS

Supported Platforms

SaaS

Customer Service / Support

24 Hour Support
Web-Based Support

Customer Service / Support

Web-Based Support

Training Options

Documentation Hub
On-Site Training

Training Options

Documentation Hub
Online Training

Company Facts

Organization Name

IQVIA

Date Founded

1982

Company Location

United States

Company Website

www.iqvia.com/solutions/integrated-global-compliance/quality-compliance/smartsolve-eqms

Company Facts

Organization Name

Flinn

Date Founded

2022

Company Location

Austria

Company Website

www.flinn.ai/

Categories and Features

Audit

Not specified

Compliance

Not specified

Document Management

Access Controls
Archiving & Retention
Collaboration Tools
Compliance Tracking
Document Archiving
Document Assembly
Document Conversion
Document Delivery
Document Indexing
Document Retention
Electronic Signature
File Recovery
File Type Conversion
Full Text Search
Offline Access
Optical Character Recognition
Version Control

Quality Management

Audit Management
Complaint Management
Corrective and Preventive Actions (CAPA)
Defect Tracking
Document Control
Equipment Management
Risk Management
Supplier Quality Control
Training Management

Risk Management

Not specified

Training

Built-in LMS
Learner Portal

Categories and Features

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