Average Ratings 0 Ratings
Average Ratings 0 Ratings
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
Integrations
Montrium Connect
No
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