QMS Manager PRO

QMS Manager PRO

ToolsForQuality
Sierra QMS

Sierra QMS

Sierra Labs
+
+

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About

QMS Manager PRO is an offline, browser-based quality management portal for small businesses, quality managers, and ISO 9001 consultants. It brings eight modules—dashboard and KPIs, document management, training and competency, internal audits, nonconformities and CAPA, customer complaints, risks and opportunities, and management review—into one local workspace. Users can organize quality records, plan audits, track corrective actions and training, assess risks, and follow improvement activities. The portal runs locally on Windows using Google Chrome, stores records in a local data structure, and supports CSV exports, PDF reporting, and backup and restore. It is a one-time digital purchase with no mandatory subscription; it is not a cloud collaboration platform or an ISO certification service.

About

Workflows designed to help you create everything needed for 510(k) submission and create quality records needed for 21 CFR Part 820 once you're ready to start selling your device. Built in tools to draft policies, procedures, and work instructions. Ability to track non-conformance, deviations, and CAPAs with customized quality management reports. As you scale and improve your workflows, policies and procedures, keep your team trained automatically. Automate validation testing on devices, apps, web, and custom off the shelf software for your enterprise. Reduce time and resources needed for lengthy testing, reporting, and approvals. Generate all your policies, procedures, and artifacts into traditional documents for audit review.

Platforms Supported

Windows Supported
Mac Not Supported
Linux Not Supported
Cloud Not Supported
On-Premises Supported
iPhone Not Supported
iPad Not Supported
Android Not Supported
Chromebook Not Supported

Platforms Supported

Windows Not Supported
Mac Not Supported
Linux Not Supported
Cloud Supported
On-Premises Not Supported
iPhone Not Supported
iPad Not Supported
Android Not Supported
Chromebook Not Supported

Audience

Small businesses and SMEs; quality managers and quality assurance professionals; ISO 9001 consultants; small manufacturers; laboratories; service providers; and organizations implementing or maintaining an ISO 9001 quality management system. Particularly suited to teams seeking offline QMS software without recurring subscriptions, cloud dependency, or complex IT infrastructure.

Audience

Organizations in need of a healthcare and life science Quality Management system

Support

Phone Support Not Supported
24/7 Live Support Not Supported
Online Supported

Support

Phone Support Not Supported
24/7 Live Support Not Supported
Online Supported

API

Offers API Not Supported

API

Offers API Not Supported

Screenshots and Videos

Screenshots and Videos

Pricing

€95.59 one-time
The regular price is €95.59 as a one-time purchase, with no mandatory monthly subscription. The final price and applicable taxes are confirmed at Etsy checkout.
Free Version Not Supported
Free Trial Not Supported

Pricing

No information available.
Free Version Not Supported
Free Trial Not Supported

Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

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Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

This software hasn't been reviewed yet. Be the first to provide a review:

Review this Software

Training

Documentation Not Supported
Webinars Supported
Live Online Not Supported
In Person Not Supported

Training

Documentation Supported
Webinars Not Supported
Live Online Not Supported
In Person Not Supported

Company Information

ToolsForQuality
Founded: 2024
Netherlands
www.toolsforquality.com/qms-manager-pro

Company Information

Sierra Labs
United States
www.sierralabs.com/quality-management/

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Categories

Quality Management Supported

Categories

CAPA Supported
Compliance Supported
Document Control Supported
Quality Management Supported
Risk Management Supported

Quality Management Features

Audit Management Supported
Complaint Management Supported
Compliance Management Supported
Corrective and Preventive Actions (CAPA) Supported
Defect Tracking Supported
Document Control Not Supported
Equipment Management Supported
ISO Standards Management Supported
Maintenance Management Supported
Risk Management Supported
Supplier Quality Control Supported
Training Management Supported

CAPA Features

Audit Management Supported
CAPA Planning Not Supported
Change Management Supported
Complaint Management Supported
Incident Management Supported
Nonconformance Tracking Supported
Quality Control Supported
Risk Management Supported
Root Cause Analysis Supported
Training Management Supported

Compliance Features

Archiving & Retention Supported
Artificial Intelligence (AI) Not Supported
Audit Management Supported
Compliance Tracking Supported
Controls Testing Not Supported
Environmental Compliance Supported
FDA Compliance Supported
HIPAA Compliance Not Supported
Incident Management Supported
ISO Compliance Supported
OSHA Compliance Supported
Risk Management Not Supported
Sarbanes-Oxley Compliance Supported
Surveys & Feedback Supported
Version Control Supported
Workflow / Process Automation Supported

Document Control Features

Archiving & Retention Supported
Automated Routing Supported
Change Management Supported
Compliance Management Supported
Electronic Signature Supported
Escalation Management Not Supported
Periodic Review Supported
Version Control Supported

Document Version Control Features

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

Risk Management Features

Alerts/Notifications Supported
Auditing Not Supported
Business Process Control Supported
Compliance Management Supported
Corrective Actions (CAPA) Supported
Dashboard Not Supported
Exceptions Management Supported
Internal Controls Management Supported
IT Risk Management Supported
Legal Risk Management Not Supported
Mobile Access Supported
Operational Risk Management Supported
Predictive Analytics Supported
Reputation Risk Management Not Supported
Response Management Supported
Risk Assessment Supported

Integrations

No info available.

Integrations

No info available.
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