Audience
Organizations in need of a healthcare and life science Quality Management system
About Sierra QMS
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.
Other Popular Alternatives & Related Software
isoTracker Quality Management is a popular cloud-based quality management software (QMS) that is used by small to medium sized businesses on a worldwide basis. It helps to manage ISO 9001, ISO 13485, ISO 22000, ISO/IEC 17025, ISO 14001, ISO 45001, ISO/TS 16949, ISO 14971 systems...plus many other systems. It also conforms to the requirements of 21 CFR Part 11 and has been validated to it.
It is a flexible and modular product with modules in document control, audit management, non-conformance management, customer complaints management, risk management, training management and CAPA management.
It can be configured to meet an organization's specific needs and provides free training and free support.
It has been independently judged to provide the best customer support in its category.
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Interfacing’s Integrated Management System (IMS) is an AI-powered platform that unifies BPM, QMS, Document Control, and GRC into one platform. Organizations use IMS to model and automate processes, control documents, manage risks, and maintain regulatory compliance with full traceability and audit readiness.
Built for highly regulated sectors such as aerospace, life sciences, finance, and government, IMS provides real-time visibility, automated workflows, and AI-driven insights that improve quality and reduce operational risk. The platform is ISO 27001 certified and fully validated for 21 CFR Part 11, making it suitable for mission-critical environments requiring strong governance, security, and control. IMS also includes low-code automation, process mining, audit management, training tracking, CAPA workflows, and dashboards to help teams streamline operations and continuously improve. AI strengthens governance, improves accuracy, and reinforces regulatory control.
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HSI Donesafe is a no-code, cloud-based EHS software that simplifies safety, compliance, and risk management, transforming complex processes into user-friendly workflows. Trusted by industries worldwide, Donesafe allows organizations to track, manage, and report on essential EHS functions from one central platform.
Our software adapts to your team’s style, enhancing everyday workflows with effortless compliance and smooth operations. Keep pace with evolving regulations and standards, from incident reporting and audits to training and risk assessments with Donesafe.
Unlock peace of mind with:
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- A scalable platform that grows in step with your team’s journey
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Put safety at the heart of every day with HSI Donesafe; protect your team, simplify compliance, and ensure everyone goes home safe.
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Affordable QMS Software for Small and Midsize Organizations
The SBS QMS Suite is an integrated Quality Management System (QMS) software solution designed to help small and midsize manufacturers and other quality-driven organizations efficiently manage ISO 9001 and related quality requirements. Five specialized modules provide document control, employee training, CAPA and nonconformance management, audits, risk management, calibration, preventive maintenance, supplier management, inspection and SPC.
SBS QMS Software is available as a cloud-based or locally installed solution and uses flexible concurrent-user licensing. Organizations may implement the complete QMS Suite or purchase individual modules to fit their quality system requirements and budget.
Professional QMS capabilities without the enterprise price tag.
The SBS QMS Suite of modules:
SBS Quality Database
- CAPA / 8D with root cause analysis
- Nonconformance management
- Risk analysis (FMEA, SWOT, etc.)
- Audit management
- Environmental Health and Safety (EHS) module
SBS Ground Control
- Employee training management (LMS)
- Document control
- Change Control
SBS Asset Tracking Database
- Calibrated equipment
- Preventive maintenance
SBS Inspection Database
- Data collection / SPC
- Control Plans
SBS Vendor Management
- Approved vendor list / AVL
- Supplier qualification plans
For a small or midsize manufacturer seeking ISO 9001 QMS functionality without enterprise-level cost and complexity, SBS QMS Suite is an option worth considering.
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Integrations
No integrations listed.
Company Information
Sierra Labs
United States
www.sierralabs.com/quality-management/
Videos and Screen Captures
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Product Details
Platforms Supported
Cloud
Training
Documentation
Support
Online
Sierra QMS Product Features
CAPA
Audit Management
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
CAPA Planning
Not Supported
Compliance
Archiving & Retention
Supported
Audit Management
Supported
Compliance Tracking
Supported
Environmental Compliance
Supported
FDA Compliance
Supported
ISO Compliance
Supported
Incident Management
Supported
OSHA Compliance
Supported
Sarbanes-Oxley Compliance
Supported
Surveys & Feedback
Supported
Version Control
Supported
Workflow / Process Automation
Supported
Artificial Intelligence (AI)
Not Supported
Controls Testing
Not Supported
HIPAA Compliance
Not Supported
Risk Management
Not Supported
Document Control
Archiving & Retention
Supported
Automated Routing
Supported
Change Management
Supported
Compliance Management
Supported
Electronic Signature
Supported
Periodic Review
Supported
Version Control
Supported
Escalation Management
Not Supported
Document Version Control
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
Quality Management
Audit Management
Supported
Complaint Management
Supported
Compliance Management
Supported
Corrective and Preventive Actions (CAPA)
Supported
Defect Tracking
Supported
Equipment Management
Supported
ISO Standards Management
Supported
Maintenance Management
Supported
Risk Management
Supported
Supplier Quality Control
Supported
Training Management
Supported
Document Control
Not Supported
Risk Management
Alerts/Notifications
Supported
Business Process Control
Supported
Compliance Management
Supported
Corrective Actions (CAPA)
Supported
Exceptions Management
Supported
IT Risk Management
Supported
Internal Controls Management
Supported
Mobile Access
Supported
Operational Risk Management
Supported
Predictive Analytics
Supported
Response Management
Supported
Risk Assessment
Supported
Auditing
Not Supported
Dashboard
Not Supported
Legal Risk Management
Not Supported
Reputation Risk Management
Not Supported
