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What is Sierra QMS?

Workflows are meticulously designed to aid in the preparation of all essential elements needed for a 510(k) submission, while also guaranteeing adherence to the quality record standards outlined in 21 CFR Part 820 as you get ready to launch your device. These workflows are equipped with tools that simplify the creation of vital policies, procedures, and work instructions. In addition, you can keep track of non-conformances, deviations, and CAPAs with custom quality management reports. As your processes develop and improve, automatic training updates ensure your team remains informed. The system also streamlines validation testing for devices, applications, websites, and bespoke software tailored to meet your business requirements. This automation greatly diminishes the time and resources typically needed for comprehensive testing, reporting, and approval tasks. Moreover, you can consolidate all your policies, procedures, and artifacts into standardized documents, making them easily accessible for audit assessments. This solution not only simplifies compliance and validation procedures but also significantly boosts operational efficiency. By integrating such advanced workflows, organizations can enhance their overall productivity and adaptability in a competitive market.

What is FlinkISO?

FlinkISO's Quality Management System (QMS) stands out as a highly favored software option for small and medium enterprises. It seamlessly integrates with ONLYOFFICE editors, enabling users to design personalized HTML forms that meet the specific needs of their QMS documents. Remarkably, you can develop your own QMS without needing any coding skills or technical expertise. The software comes equipped with various essential modules, including Audit Management, Customer Complaints, Document Management, and Change Control, among others. Additionally, the intuitive drag-and-drop feature allows for easy incorporation of custom business rules, email notifications, and supplementary HTML fields. FlinkISO offers versatile and budget-friendly payment plans for both on-premise and cloud-based applications. Users opting for the cloud version benefit from a generous 45-day free trial, while the on-premise version is priced at USD80 per month. This combination of features and affordability makes FlinkISO a compelling choice for businesses looking to enhance their quality management processes.

Media

Media

Integrations Supported

Integrations Supported

ONLYOFFICE Docs

API Availability

API Availability

Has API

Pricing Information

Pricing not provided

Pricing Information

$80.00/month
Available on-premise and on-Cloud. On-Premise Lite & Enterprise versions.
Free Version
Free Trial Offered?

Supported Platforms

SaaS

Supported Platforms

SaaS
iPhone
iPad
Windows
Mac
On-Prem
Linux

Customer Service / Support

Web-Based Support

Customer Service / Support

24 Hour Support
Web-Based Support

Training Options

Documentation Hub

Training Options

Documentation Hub
Online Training

Company Facts

Organization Name

Sierra Labs

Company Location

United States

Company Website

www.sierralabs.com/quality-management/

Company Facts

Organization Name

Techmentis Global Services

Date Founded

2012

Company Location

India

Company Website

www.flinkiso.com

Categories and Features

CAPA

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

Compliance

Archiving & Retention
Audit Management
Compliance Tracking
Environmental Compliance
FDA Compliance
ISO Compliance
Incident Management
OSHA Compliance
Sarbanes-Oxley Compliance
Surveys & Feedback
Version Control
Workflow / Process Automation

Document Control

Archiving & Retention
Automated Routing
Change Management
Compliance Management
Electronic Signature
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
Equipment Management
ISO Standards Management
Maintenance Management
Risk Management
Supplier Quality Control
Training Management

Risk Management

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

Categories and Features

Document Control

Change Management
Compliance Management
Periodic Review
Version Control

Document Management

Access Controls
Collaboration Tools
Document Archiving
Document Indexing
Forms Management
Version Control

Quality Management

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

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