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Average Ratings 0 Ratings

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ease
features
design
support

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Write a Review

Description

Carizma QM is an online application designed to assist users in overseeing the complete lifecycle of regulated documents, encompassing stages from drafting and reviewing to approving, releasing, and archiving. It enables the creation and management of essential documents, such as Standard Operating Procedures (SOPs), through integrated workflows that facilitate the review and approval process. Upon approval, the system automatically initiates a training workflow where users must acknowledge they have read and understood the document. The software incorporates an electronic signature feature that complies with 21 CFR Part 11 regulations, ensuring a display of users who have acknowledged their understanding of the documents. Additionally, it maintains a validated audit trail, enhancing users' ability to manage regulated documents directly within Carizma QM. Authors can specify crucial information, including the document type (such as SOP, work instruction, form, or checklist), the document title, the process owner (the relevant department), and the user groups to which the document applies, along with setting a review cycle. Users are notified via email in a timely manner when a document requires their review, and Carizma QM generates the initial document framework to streamline this process. Overall, the software simplifies and enhances the management of regulated documentation through its comprehensive features.

Description

QFacts is a comprehensive cloud-based Quality Management System designed specifically for pharmacies, compounding facilities, and other regulated sectors. It encompasses the entire quality lifecycle, featuring controlled document management with versioning and approval workflows, training and competency tracking with curriculum-aligned assignments, as well as event and complaint management, root cause analysis, CAPA oversight, and change control, all accompanied by thorough audit trails. This system is built to comply with GAMP 5 and adhere to European GMP and GDP standards, employing role-based access controls that span organizations, locations, and departments. Quality managers can customize review workflows, keep track of due dates, and oversee compliance via real-time dashboards. Each action taken within the system is meticulously logged and traceable, providing inspectors and auditors with a transparent chain of accountability that extends from document approval through to the completion of training and the resolution of corrective actions. By ensuring such detailed oversight, QFacts significantly enhances the overall efficiency and reliability of quality management processes.

API Access

Has API

API Access

Has API

Screenshots View All

Screenshots View All

No images available

Integrations

Adobe Acrobat
Microsoft Word

Integrations

Adobe Acrobat
Microsoft Word

Pricing Details

No price information available.
Free Trial
Free Version

Pricing Details

$17/month/user
Free Trial
Free Version

Deployment

Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook

Deployment

Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook

Customer Support

Business Hours
Live Rep (24/7)
Online Support

Customer Support

Business Hours
Live Rep (24/7)
Online Support

Types of Training

Training Docs
Webinars
Live Training (Online)
In Person

Types of Training

Training Docs
Webinars
Live Training (Online)
In Person

Vendor Details

Company Name

Axicos

Founded

2007

Country

Switzerland

Website

www.axicos.com/software-solutions

Vendor Details

Company Name

QFacts

Founded

2024

Country

Belgium

Website

qfacts.be

Product Features

Legal Document Management

Access Controls
Archiving & Retention
Collaboration
Contract Management
Document Assembly
Document Indexing
Document Tagging
Full Text Search
Version Control

Product Features

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

Alternatives

QM Reviews

QM

SOLABS

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