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What is qmsWrapper?

qmsWrapper is a connected Quality Management System (eQMS) designed specifically for medical device startups and SMEs. Instead of implementing a complex enterprise platform from day one, companies can start with Foundation and expand to Lifecycle and Vigilance as their quality system matures. Built for ISO 13485, ISO 14971, FDA QMSR, FDA 21 CFR Part 11, and EU MDR, qmsWrapper connects document control, training, CAPA, quality events, risk management, technical documentation, supplier quality, and traceability in one platform. AI assists users with quality processes while every action remains human-controlled and fully auditable. Start where the need is greatest. Keep everything you build. Grow your QMS without rebuilding or migrating to another system.

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.

Media

Media

Integrations Supported

Jira

Integrations Supported

Indent

API Availability

API Availability

Pricing Information

€3,499
Foundation starts at €3,499 per year with unlimited users. Lifecycle and Vigilance pricing is available on request. All editions are designed to grow with your quality management needs without requiring migration to a new platform.
Free Trial Offered?

Pricing Information

$542 one-time payment

Supported Platforms

SaaS
Windows
Mac
Linux

Supported Platforms

SaaS

Customer Service / Support

Web-Based Support

Customer Service / Support

24 Hour Support
Web-Based Support

Training Options

Documentation Hub
Online Training

Training Options

Documentation Hub
On-Site Training

Company Facts

Organization Name

qmsWrapper

Company Location

Canada

Company Website

www.qmswrapper.com

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

Categories and Features

CAPA

Audit Management
CAPA Planning
Change Management
Complaint Management
Nonconformance Tracking
Quality Control
Risk Management
Root Cause Analysis
Training Management

Quality Management

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

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

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