Average Ratings 0 Ratings

Total
ease
features
design
support

No User Reviews. Be the first to provide a review:

Write a Review

Average Ratings 0 Ratings

Total
ease
features
design
support

No User Reviews. Be the first to provide a review:

Write a Review

Description

Uncover the overlooked and unexamined aspects of your workplace. By fostering unprecedented engagement and transparency, you can cultivate safer, more enjoyable, and more efficient environments for your team. Frontline workers and leaders now anticipate seamless, mobile-first solutions for reporting, workflows, and communication. The majority of reporting systems often fail to engage the wider workforce, resulting in usage by only a limited number of individuals. This can lead to a lack of comprehensive situational awareness, causing unforeseen challenges. It is not merely the management teams that hold the key to understanding critical issues, but rather the employees in the field who notice the subtle yet significant details that influence your operations. They are eager for an opportunity to express their thoughts, contribute actively, resolve challenges, and make a difference. The presence of disparate reporting tools for various functions raises the barrier for users, making it more difficult for them to participate. Falcony equips your team and stakeholders with an ideal tool designed to empower them to share their insights, engage in inspections, collaborate effectively, and find resolutions. Ultimately, fostering an environment where every voice matters can lead to transformative changes in your workplace dynamics.

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 No 

API Access

Has API No 

Screenshots View All

Screenshots View All

Integrations

BI Book Yes 
Jira Yes 
Microsoft Power BI Yes 
Microsoft SharePoint Yes 
SAP Cloud Platform Yes 
Workday Extend Yes 

Integrations

BI Book No 
Jira No 
Microsoft Power BI No 
Microsoft SharePoint No 
SAP Cloud Platform No 
Workday Extend No 

Pricing Details

€150 per month
Free Trial Yes 
Free Version No 

Pricing Details

No price information available.
Free Trial No 
Free Version No 

Deployment

Web-Based Yes 
On-Premises No 
iPhone App No 
iPad App No 
Android App No 
Windows No 
Mac No 
Linux No 
Chromebook No 

Deployment

Web-Based Yes 
On-Premises No 
iPhone App No 
iPad App No 
Android App No 
Windows No 
Mac No 
Linux No 
Chromebook No 

Customer Support

Business Hours Yes 
Live Rep (24/7) Yes 
Online Support Yes 

Customer Support

Business Hours No 
Live Rep (24/7) No 
Online Support Yes 

Types of Training

Training Docs Yes 
Webinars Yes 
Live Training (Online) Yes 
In Person Yes 

Types of Training

Training Docs Yes 
Webinars No 
Live Training (Online) No 
In Person No 

Vendor Details

Company Name

Falcony

Founded

2012

Country

Finland

Website

www.falcony.io

Vendor Details

Company Name

Sierra Labs

Country

United States

Website

www.sierralabs.com/quality-management/

Product Features

Audit

Alerts / Notifications Yes 
Audit Planning No 
Compliance Management Yes 
Dashboard Yes 
Exceptions Management Yes 
Forms Management Yes 
Issue Management Yes 
Mobile Access Yes 
Multi-Year Planning No 
Risk Assessment Yes 
Workflow Management Yes 

CAPA

Audit Management Yes 
CAPA Planning No 
Change Management Yes 
Complaint Management Yes 
Incident Management Yes 
Nonconformance Tracking Yes 
Quality Control Yes 
Risk Management Yes 
Root Cause Analysis Yes 
Training Management Yes 

EHS Management

Audit Management Yes 
Corrective / Preventive Actions No 
Environmental Management No 
Environmental Risk Assessment Yes 
Forms Management Yes 
Incident Management Yes 
Industrial Safety Management Yes 
Injury Reporting Yes 
Inspection Management Yes 
MSDS No 
OSHA Recordkeeping Yes 
Occupational Health Management Yes 
Safety Risk Assessment Yes 
Training Management Yes 
Waste Management No 

Facility Management

Asset Management No 
Commercial Properties Yes 
Equipment Management Yes 
Facility Scheduling No 
Incident Management Yes 
Inspection Management Yes 
Inventory Control Yes 
Maintenance Tracking No 
Preventive Maintenance Yes 
Residential Properties Yes 
Room Scheduling No 
Schools Yes 
Space Planning No 
Vendor Management No 
Visitor Management Yes 
Work Order Management Yes 

Incident Management

Audit Trail No 
Corrective Actions (CAPA) No 
Disaster Recovery No 
IT Incident Management Yes 
Incident Reporting Yes 
OSHA Compliance Yes 
Root-Cause Diagnosis No 
Safety Management No 
Task Management Yes 
Ticket Management Yes 

Inspection

Appointment Management No 
Customer Database Yes 
Dispatch Management Yes 
Equipment Tracking No 
Photos In Reports No 
Print on Site No 
Report Templates Yes 
Speech Recognition No 
Subcontractor Management Yes 

Physical Security

Checkpoint Tracking No 
Customer Management No 
Data Collection No 
Event Management No 
Incident Management Yes 
Investigation Management Yes 
Multiple Alarm Queues No 

Quality Management

Audit Management Yes 
Complaint Management Yes 
Compliance Management Yes 
Corrective and Preventive Actions (CAPA) Yes 
Defect Tracking Yes 
Document Control No 
Equipment Management Yes 
ISO Standards Management Yes 
Maintenance Management Yes 
Risk Management Yes 
Supplier Quality Control Yes 
Training Management Yes 

Risk Management

Alerts/Notifications Yes 
Auditing No 
Business Process Control Yes 
Compliance Management Yes 
Corrective Actions (CAPA) No 
Dashboard Yes 
Exceptions Management Yes 
IT Risk Management Yes 
Internal Controls Management Yes 
Legal Risk Management Yes 
Mobile Access Yes 
Operational Risk Management Yes 
Predictive Analytics Yes 
Reputation Risk Management Yes 
Response Management Yes 
Risk Assessment Yes 

Safety Management

Audit Management Yes 
Corrective / Preventive Actions No 
Incident Management Yes 
Injury Reporting Yes 
Inspection Management Yes 
OSHA Recordkeeping Yes 
Safety Risk Assessment Yes 
Training Management Yes 

Whistleblowing

Access Controls / Permissions Yes 
Automated Routing Yes 
Compliance Management Yes 
Customizable Branding Yes 
Multi-Language Support Yes 
Real-Time Chat No 
Reporting / Analytics Yes 
Workflow / Process Automation Yes 

Product Features

CAPA

Audit Management Yes 
CAPA Planning No 
Change Management Yes 
Complaint Management Yes 
Incident Management Yes 
Nonconformance Tracking Yes 
Quality Control Yes 
Risk Management Yes 
Root Cause Analysis Yes 
Training Management Yes 

Compliance

Archiving & Retention Yes 
Artificial Intelligence (AI) No 
Audit Management Yes 
Compliance Tracking Yes 
Controls Testing No 
Environmental Compliance Yes 
FDA Compliance Yes 
HIPAA Compliance No 
ISO Compliance Yes 
Incident Management Yes 
OSHA Compliance Yes 
Risk Management No 
Sarbanes-Oxley Compliance Yes 
Surveys & Feedback Yes 
Version Control Yes 
Workflow / Process Automation Yes 

Document Control

Archiving & Retention Yes 
Automated Routing Yes 
Change Management Yes 
Compliance Management Yes 
Electronic Signature Yes 
Escalation Management No 
Periodic Review Yes 
Version Control Yes 

Document Version Control

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

Quality Management

Audit Management Yes 
Complaint Management Yes 
Compliance Management Yes 
Corrective and Preventive Actions (CAPA) Yes 
Defect Tracking Yes 
Document Control No 
Equipment Management Yes 
ISO Standards Management Yes 
Maintenance Management Yes 
Risk Management Yes 
Supplier Quality Control Yes 
Training Management Yes 

Risk Management

Alerts/Notifications Yes 
Auditing No 
Business Process Control Yes 
Compliance Management Yes 
Corrective Actions (CAPA) Yes 
Dashboard No 
Exceptions Management Yes 
IT Risk Management Yes 
Internal Controls Management Yes 
Legal Risk Management No 
Mobile Access Yes 
Operational Risk Management Yes 
Predictive Analytics Yes 
Reputation Risk Management No 
Response Management Yes 
Risk Assessment Yes 

Alternatives

Unified Analytics Reviews

Unified Analytics

Unified Analytics AS

Alternatives

Dot Compliance QMS Reviews

Dot Compliance QMS

QMS for Life Sciences
QT9 QMS Reviews

QT9 QMS

QT9 Software
HSI Donesafe Reviews

HSI Donesafe

Donesafe
Intelex Reviews

Intelex

Intelex Technologies