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Average Ratings 0 Ratings

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ease
features
design
support

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Description

QualityKick is a cloud-based Quality Management System (QMS) tailored for the biological sciences sector, designed to enhance compliance and streamline various quality management processes. It offers a suite of modules, each addressing critical components such as document control, training, change management, incident tracking, CAPA (Corrective and Preventive Actions), risk evaluation, qualification, and supplier and equipment audits. Being a web-based platform, it ensures accessibility from any location and on any mobile device, including computers, smartphones, and tablets. New users benefit from an automated guided tour upon their initial login, facilitating a smoother onboarding experience. The system supports document editing with MS Word and enables a customizable review and approval workflow, enhancing collaboration and efficiency. Various event types, including deviations, nonconformities, and customer complaints, can be configured to suit organizational needs. Additionally, it allows users to establish CAPA plans, document necessary actions, and assess their effectiveness, making it a comprehensive solution for quality management in the pharmaceutical, biotechnology, and medical fields. With its user-friendly interface and robust features, QualityKick is poised to transform how organizations manage quality compliance.

Description

Workflows are specifically developed to assist you in preparing all necessary components for a 510(k) submission, while also ensuring compliance with the quality record requirements set forth in 21 CFR Part 820 as you prepare to market your device. These workflows come equipped with tools to facilitate the drafting of essential policies, procedures, and work instructions. Furthermore, you can monitor non-conformances, deviations, and CAPAs through tailored quality management reports. As your processes evolve and enhance, you can ensure your team receives automatic training updates. The system also automates validation testing for devices, applications, websites, and custom software tailored to your business needs. This automation significantly reduces the time and resources that would otherwise be consumed by extensive testing, reporting, and approval processes. Additionally, you can compile all your policies, procedures, and artifacts into standard documents, making them readily available for audit evaluations. Overall, this solution streamlines the compliance and validation processes, thereby enhancing operational efficiency.

API Access

Has API

API Access

Has API

Screenshots View All

Screenshots View All

Integrations

Microsoft Word

Integrations

Microsoft Word

Pricing Details

No price information available.
Free Trial
Free Version

Pricing Details

No price information available.
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

SoftDoit

Country

Spain

Website

www.softwaredoit.es/qualitykick/qualitykick.html

Vendor Details

Company Name

Sierra Labs

Country

United States

Website

www.sierralabs.com/quality-management/

Product Features

CAPA

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

Compliance

Archiving & Retention
Artificial Intelligence (AI)
Audit Management
Compliance Tracking
Controls Testing
Environmental Compliance
FDA Compliance
HIPAA Compliance
ISO Compliance
Incident Management
OSHA Compliance
Risk Management
Sarbanes-Oxley Compliance
Surveys & Feedback
Version Control
Workflow / Process Automation

Document Control

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

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
Exceptions Management
IT Risk Management
Internal Controls Management
Legal Risk Management
Mobile Access
Operational Risk Management
Predictive Analytics
Reputation Risk Management
Response Management
Risk Assessment

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