Sierra QMS

Sierra QMS

Sierra Labs
Trevally

Trevally

ManualMaster
+
+

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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.

About

Trevally is ManualMaster’s next-generation QHSE platform covering the full PDCA loop. In one web or on-prem environment it delivers controlled document and version management with audit trails, process mapping, risk and standard control, QA registrations and smart web forms. Extra modules handle incidents, complaints, audits, deviations, tasks and actions, all surfaced in a role-based dashboard with live KPIs, reports and graphs. ISO-27001 hosting, backups, SSO, 2-factor login and granular rights protect data; multi-language UI, digital signatures and mobile access boost adoption. An open REST API plus the 2024 Certifeye connector imports supplier certificates automatically. Q-Learning, alerts and automated workflows drive continual improvement, while flexible cloud or server licensing keeps change agile yet traceable.

Platforms Supported

Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook

Platforms Supported

Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook

Audience

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

Audience

Governments, hospitals and healthcare, industry, chemical industry, food production, professional services, para-statal entities, transport and logistics, horticulture, floriculture, manufacturing, business services, construction and infrastructure

Support

Phone Support
24/7 Live Support
Online

Support

Phone Support
24/7 Live Support
Online

API

Offers API

API

Offers API

Screenshots and Videos

Screenshots and Videos

Pricing

No information available.
Free Version
Free Trial

Pricing

$6000/year
Free Version
Free Trial

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

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
Webinars
Live Online
In Person

Training

Documentation
Webinars
Live Online
In Person

Company Information

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

Company Information

ManualMaster
Founded: 1992
The Netherlands
manualmaster.com

Alternatives

Alternatives

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Dot Compliance QMS

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Dot Compliance QMS

Dot Compliance QMS

QMS for Life Sciences
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iCompliance

iCompliance.online
Qualcy QMS

Qualcy QMS

Qualcy Systems
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QT9 QMS

QT9 Software
Karminn EzyPro

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Total Lean Management (TLM) Software

Total Lean Management (TLM) Software

Lean & Mean Business Systems

Categories

Categories

Quality Management Features

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

CAPA Features

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

Compliance Features

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

Document Control Features

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

Document Version Control Features

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

Risk Management Features

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

Quality Management Features

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

Integrations

AFAS Software
Active Directory
GROW with SAP
HelloID
M3

Integrations

AFAS Software
Active Directory
GROW with SAP
HelloID
M3
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