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Average Ratings 0 Ratings

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ease
features
design
support

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Write a Review

Description

IntegPro is a specialized solution tailored to assist organizations in conducting risk assessments across all systems, thereby facilitating the tracking, prioritization, and management of compliance status within the company. Following the FDA's directives on data integrity, this software empowers quality leaders, departmental heads, and system owners to quickly ascertain their data integrity compliance, identify compliance deficiencies, and implement corrective measures. The application adheres to the requirements of 21 CFR Part 11, enabling seamless paperless management and monitoring of data integrity status. It is designed to be utilized by individual departments or as part of a broader corporate initiative focused on compliance with data integrity standards. With its user-friendly interface, IntegPro serves as an efficient tool for streamlining the management and tracking of data integrity processes throughout your organization. Additionally, it offers a convenient paperless solution for monitoring compliance status, ensuring that your company can maintain high standards of data integrity. The software comes ready to use, complete with pre-configured settings for immediate deployment, making it an accessible option for organizations of any size.

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.

API Access

Has API No 

API Access

Has API No 

Screenshots View All

Screenshots View All

Integrations

Montrium Connect No 

Integrations

Montrium Connect 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 Yes 
Mac No 
Linux No 
Chromebook 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 

Customer Support

Business Hours Yes 
Live Rep (24/7) Yes 
Online Support Yes 

Customer Support

Business Hours Yes 
Live Rep (24/7) No 
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 Yes 
Live Training (Online) Yes 
In Person Yes 

Vendor Details

Company Name

CIMINFO Software

Founded

1988

Country

United States

Website

www.part11solutions.com

Vendor Details

Company Name

Montrium

Country

Canada

Website

www.montrium.com

Product Features

Compliance

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

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 

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