Quality ConnectMontrium
|
||||||
Related Products
|
||||||
About
Qualitum is an agentic platform for computer system validation (CSV/CQV) in regulated life-sciences. It drafts IQ/OQ/PQ protocols, GAMP 5 classifications and audit trails straight from source documents (URS, P&IDs, SOP libraries), with every requirement traced end-to-end through a queryable graph that replaces spreadsheet RTMs. All ALCOA+ data-integrity criteria are monitored on every record, not samples, with humans reviewing and approving agent output. Qualitum runs single-tenant on AWS, Azure or on-prem, with customer-managed keys and no training rights on customer data, and connects to systems of record already in use (Veeva, MasterControl, TrackWise, AVEVA PI, Tulip and others). Built for Heads of Validation and validation consultancies at pharma, biotech and medical-device companies. Annual per-site licence, quoted on request; an 8-12 week fixed-fee pilot (one system) is available.
|
About
Enterprise Quality Management Software in the cloud for the life sciences. In today’s complex operational environment, technology plays a vital role in ensuring that QA is made aware of the issues as they happen. Gaining insight into the performance of your quality management system and the current state of your operation helps you to be more proactive, which minimizes risk and eliminates costly delays. Montrium has designed its Enterprise Quality Management system (EQMS) to enable life science companies to tackle the quality challenges that they face in content management head-on. All of our SharePoint QMS modules can be used independently or together as a fully integrated quality management system. These modules are available as part of our Montrium Connect Platform and can be deployed on-premise or in the cloud. Perfect for pharmaceutical companies, contract manufacturing organizations, medical device companies. Built to achieve compliance with GMP and GCP requirements.
|
|||||
Platforms Supported
Windows
Not Supported
Mac
Not Supported
Linux
Not Supported
Cloud
Supported
On-Premises
Supported
iPhone
Not Supported
iPad
Not Supported
Android
Not Supported
Chromebook
Not Supported
|
Platforms Supported
Windows
Not Supported
Mac
Not Supported
Linux
Not Supported
Cloud
Supported
On-Premises
Supported
iPhone
Not Supported
iPad
Not Supported
Android
Not Supported
Chromebook
Not Supported
|
|||||
Audience
Heads of Validation and QA/validation managers at pharma, biotech and medical-device companies; validation consultancies and implementation partners
|
Audience
Life science companies looking for an Enterprise Quality Management system (EQMS) to handle critical applications
|
|||||
Support
Phone Support
Not Supported
24/7 Live Support
Not Supported
Online
Not Supported
|
Support
Phone Support
Supported
24/7 Live Support
Not Supported
Online
Supported
|
|||||
API
Offers API
Not Supported
|
API
Offers API
Not Supported
|
|||||
Screenshots and VideosNo images available
|
Screenshots and Videos |
|||||
Pricing
No information available.
Free Version
Not Supported
Free Trial
Not Supported
|
Pricing
No information available.
Free Version
Not Supported
Free Trial
Not Supported
|
|||||
Reviews/
|
Reviews/
|
|||||
Training
Documentation
Not Supported
Webinars
Not Supported
Live Online
Not Supported
In Person
Not Supported
|
Training
Documentation
Supported
Webinars
Supported
Live Online
Supported
In Person
Supported
|
|||||
Company InformationQualitum
qualitum.ai
|
Company InformationMontrium
Canada
www.montrium.com
|
|||||
Alternatives |
Alternatives |
|||||
|
|
||||||
|
|
||||||
|
|
|
|||||
|
|
||||||
Categories |
Categories |
|||||
Quality Management Features
Audit Management
Not Supported
Complaint Management
Supported
Compliance Management
Supported
Corrective and Preventive Actions (CAPA)
Supported
Defect Tracking
Supported
Document Control
Supported
Equipment Management
Not Supported
ISO Standards Management
Supported
Maintenance Management
Not Supported
Risk Management
Supported
Supplier Quality Control
Not Supported
Training Management
Supported
|
||||||
Integrations
Montrium Connect
Not Supported
|
||||||
|
|
|