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features
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support

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Description

Cloud-based Enterprise Quality Management Software tailored for the life sciences sector is essential in navigating today’s intricate operational landscape. With technology at the forefront, it ensures that quality assurance teams are promptly informed of issues as they arise, fostering a culture of proactive management. By gaining a clear view of the quality management system's performance alongside operational conditions, organizations can significantly reduce risks and avoid expensive delays. Montrium has crafted its Enterprise Quality Management System (EQMS) specifically to help life science companies confront their quality management challenges directly, particularly in content management. Our SharePoint QMS modules are designed for flexibility; they can function independently or as part of a cohesive quality management system. These modules are accessible through our Montrium Connect Platform and can be implemented either on-premise or via cloud solutions, making them ideal for pharmaceutical firms, contract manufacturing organizations, and medical device companies. Each component is meticulously built to ensure compliance with Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP), thereby supporting organizations in maintaining the highest quality standards. Ultimately, this comprehensive approach not only enhances efficiency but also strengthens the overall integrity of the quality management process.

Description

Streamline tedious and repetitive tasks so you can concentrate on delivering products that are both safer and more effective, and do so at a quicker pace. IQVIA’s SmartSolve Postmarket Surveillance offers a comprehensive SaaS solution for postmarket surveillance (PMS), equipping you with best practices for the centralized management of all PMS activities. The Fusion event, tailored for SmartSolve and RIM Smart users, provides extensive education on pertinent quality and regulatory subjects, offering actionable insights and practical tools applicable across any Life Sciences organization. Initially launched as a live conference for SmartSolve users, Fusion has transformed over recent years to encompass both virtual and in-person events for the broader SmartSolve and RIM Smart communities. Enhance your compliance response times, accuracy, predictive planning, and overall efficiency through the IQVIA SmartSolve™ Regulatory Connector. This Connected Intelligence framework represents our forward-thinking, integrated strategy aimed at fostering significant operational efficiencies across the board, ultimately benefiting your organization in numerous ways. Embrace these advancements to ensure your organization remains competitive in a rapidly evolving landscape.

API Access

Has API No 

API Access

Has API No 

Screenshots View All

Screenshots View All

Integrations

Indent No 
Montrium Connect Yes 

Integrations

Indent Yes 
Montrium Connect No 

Pricing Details

No price information available.
Free Trial No 
Free Version No 

Pricing Details

$542 one-time payment
Free Trial No 
Free Version No 

Deployment

Web-Based Yes 
On-Premises Yes 
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 Yes 
Live Rep (24/7) No 
Online Support Yes 

Customer Support

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

Types of Training

Training Docs Yes 
Webinars Yes 
Live Training (Online) Yes 
In Person Yes 

Types of Training

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

Vendor Details

Company Name

Montrium

Country

Canada

Website

www.montrium.com

Vendor Details

Company Name

IQVIA

Founded

1982

Country

United States

Website

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

Product Features

Quality Management

Audit Management No 
Complaint Management Yes 
Compliance Management Yes 
Corrective and Preventive Actions (CAPA) Yes 
Defect Tracking Yes 
Document Control Yes 
Equipment Management No 
ISO Standards Management Yes 
Maintenance Management No 
Risk Management Yes 
Supplier Quality Control No 
Training Management Yes 

Product Features

Audit

Alerts / Notifications No 
Audit Planning No 
Compliance Management No 
Dashboard No 
Exceptions Management No 
Forms Management No 
Issue Management No 
Mobile Access No 
Multi-Year Planning No 
Risk Assessment No 
Workflow Management No 

Compliance

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

Document Management

Access Controls Yes 
Archiving & Retention Yes 
Collaboration Tools Yes 
Compliance Tracking Yes 
Document Archiving Yes 
Document Assembly Yes 
Document Capture No 
Document Conversion Yes 
Document Delivery Yes 
Document Indexing Yes 
Document Retention Yes 
Electronic Signature Yes 
Email Management No 
File Recovery Yes 
File Type Conversion Yes 
Forms Management No 
Full Text Search Yes 
Offline Access Yes 
Optical Character Recognition Yes 
Print Management No 
Version Control Yes 

Quality Management

Audit Management Yes 
Complaint Management Yes 
Compliance Management No 
Corrective and Preventive Actions (CAPA) Yes 
Defect Tracking Yes 
Document Control Yes 
Equipment Management Yes 
ISO Standards Management No 
Maintenance Management No 
Risk Management Yes 
Supplier Quality Control Yes 
Training Management Yes 

Risk Management

Alerts/Notifications No 
Auditing No 
Business Process Control No 
Compliance Management No 
Corrective Actions (CAPA) No 
Dashboard No 
Exceptions Management No 
IT Risk Management No 
Internal Controls Management No 
Legal Risk Management No 
Mobile Access No 
Operational Risk Management No 
Predictive Analytics No 
Reputation Risk Management No 
Response Management No 
Risk Assessment No 

Training

Academic / Education No 
Asynchronous Learning No 
Blended Learning No 
Built-In Course Authoring No 
Built-in LMS Yes 
Certification Management No 
Corporate / Business No 
Learner Portal Yes 
Mobile Learning No 
Simulation No 
Synchronous Learning No 
Training Companies No 
eCommerce No 

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