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What is MasterControl?

Bringing innovative products to market in heavily regulated sectors often feels like an unending series of compromises. However, MasterControl's GxP software streamlines workflows, ensuring that you don't have to sacrifice quality for cost or innovation in the face of regulation. With a perfect blend of completeness and connectivity, combined with a focus on flexibility and speed, MasterControl Quality Excellence turns quality data and processes into a significant competitive advantage. The journey toward modernizing your manufacturing operations begins with advanced software solutions. MasterControl Manufacturing Excellence simplifies the digital transformation of manufacturing, covering everything from work orders and production records to logbooks and work instructions, making it the most straightforward approach to digitizing your manufacturing processes.

What is Carizma QM?

Carizma QM is a web-based tool crafted to help users manage the entire lifecycle of regulated documents, from the initial drafting and review phases all the way through to approval, release, and eventual archiving. It allows for the creation and oversight of crucial documents like Standard Operating Procedures (SOPs) via integrated workflows that promote efficient review and approval. Once a document receives approval, the system automatically triggers a training workflow, requiring users to confirm that they have read and comprehended the document. The application includes an electronic signature capability that adheres to 21 CFR Part 11 regulations, ensuring a record of users who have acknowledged their understanding of the documents. Furthermore, it provides a validated audit trail, which significantly aids users in managing regulated documents directly within Carizma QM. Authors have the ability to define important details such as the document type (including SOP, work instruction, form, or checklist), the title of the document, the process owner (designated department), and the applicable user groups, while also establishing a review cycle. Timely notifications are sent to users via email when their review of a document is necessary, and Carizma QM facilitates the creation of an initial document framework to make this process more efficient. By offering these extensive features, the software not only streamlines but also enhances the management of regulated documentation, ensuring compliance and efficiency throughout the entire process. Ultimately, Carizma QM serves as an indispensable resource for organizations seeking to maintain rigorous standards in their document management practices.

Media

Media

Integrations Supported

Microsoft Word
Inspired eLearning HR & Compliance
Microsoft Excel
Microsoft PowerPoint
Res_Q
SAP Business ByDesign
Showpad Coach
VIPRE Security Awareness

Integrations Supported

Microsoft Word
Adobe Acrobat

API Availability

Has API

API Availability

Pricing Information

$25,000 / 1st year
25k for first year with a 5 license minimum

Pricing Information

Pricing not provided

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac

Supported Platforms

SaaS

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Customer Service / Support

Standard Support
Web-Based Support

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Training Options

Documentation Hub

Company Facts

Organization Name

MasterControl

Date Founded

1994

Company Location

United States

Company Website

www.mastercontrol.com

Company Facts

Organization Name

Axicos

Date Founded

2007

Company Location

Switzerland

Company Website

www.axicos.com/software-solutions

Categories and Features

CAPA

Audit Management
CAPA Planning
Change Management
Complaint Management
Incident Management
Nonconformance Tracking
Quality Control
Risk Management
Training Management

Change Management

Approval Workflow
Audit Trail
Change Planning
Compliance Management
Release Management
Task Management
Training Management

Complaint Management

Complaint Classification
Corrective Actions (CAPA)
Customer Complaint Tracking
Feedback Management
Forms Management
Issue Tracking
Quality Assurance Management
Routing

Compliance

Archiving & Retention
Audit Management
Compliance Tracking
Environmental Compliance
FDA Compliance
HIPAA Compliance
ISO Compliance
Risk Management
Version Control
Workflow / Process Automation

Document Collection

Not specified

Document Control

Archiving & Retention
Automated Routing
Change Management
Compliance Management
Electronic Signature
Escalation Management
Periodic Review
Version Control

Document Management

Access Controls
Archiving & Retention
Collaboration Tools
Compliance Tracking
Document Archiving
Document Assembly
Document Conversion
Document Delivery
Document Indexing
Document Retention
Electronic Signature
Email Management
File Recovery
File Type Conversion
Forms Management
Full Text Search
Offline Access
Optical Character Recognition
Print Management
Version Control

Document Version Control

Access Controls/Permissions
Approval Process Control
Archiving & Retention
Audit Trail
Commenting / Notes
Document Check-in / Check-out
For Engineering Documents
Revision History
Version Comparison
Version Rollback

EHS Management

Not specified

Food Safety

Not specified

IT Risk Management

Not specified

Occupational Health

Not specified

Quality Management

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

Risk Management

Alerts/Notifications
Auditing
Business Process Control
Compliance Management
Corrective Actions (CAPA)
Dashboard
Internal Controls Management
Mobile Access
Operational Risk Management
Predictive Analytics
Response Management
Risk Assessment

Safety Management

Not specified

Shop Floor Management

Not specified

SPC

Corrective Actions (CAPA)
Regulatory Compliance

Work Instructions

Version Control

Categories and Features

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