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.
Integrations
No integrations listed.
Company Information
Sierra Labs
United States
www.sierralabs.com/quality-management/
Videos and Screen Captures
TenForce
TenForce is an EHSQ and operational risk management solution designed for utility, manufacturing, and government organizations.
The software enables plant managers to mitigate risk and maintain operational efficiency.
TenForce offers various integrated modules to help streamline workflows such as audits, observations, incident management, lockout/tagout (LOTO), permit to work, management of change, and shift management.
It offers mobile capabilities, which allow field workers and inspectors to access the software on mobile devices. Its built-in data analytics and reporting functionality enables managers to gain insights into the processes and risks of their industrial plants or public infrastructure assets. This visibility helps them address environmental, health, safety, quality, and compliance issues.
TenForce helps manufacturers optimize their established processes while minimizing incidents.
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LogicalDOC
LogicalDOC helps organizations around the world gain complete control over document management. Focusing on business process automation and fast content retrieval, this premier document management system (DMS) allows teams to create, collaborate, and manage large volumes of documents and stores valuable company data in a centralized repository. System features include a drag-and-drop document upload, forms management, optical character recognition (OCR), duplicate detection, barcode recognition, event logging, document archiving, integrated document workflow, and so much more.
Schedule a free, no obligation, one-on-one demo today.
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isoTracker Quality Management
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.
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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Enterprise Process Center (EPC)
Interfacing’s Digital Twin Organization software provides transparency and Governance to improve Quality, Efficiency, and ensure Regulatory Compliance.
Map, analyze, and automate processes, manage regulatory compliance, assess risks within a single platform! Interfacing’s digital twin solution (Enterprise Process Center - EPC) is an enterprise management system that helps companies digitalize processes to streamline operations, increase productivity, and continuously improve.
Interfacing’s digital business platform – Rapid Application Development (RAD) Tools, with its Low-Code Development methodology will optimize usage of your technical resources and maximize transparency for ongoing improvement.
Discover how our Low-Code Rapid Application Development module provides all the tools to create and deploy Custom, Scalable, Secure, and Mobile ready Applications in Days vs. Months!
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Product Details
Platforms Supported
SaaS
Training
Documentation
Support
Online
Sierra QMS Product Features
CAPA
Audit Management
Change Management
Complaint Management
Incident Management
Nonconformance Tracking
Quality Control
Risk Management
Root Cause Analysis
Training Management
CAPA Planning
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
Artificial Intelligence (AI)
Controls Testing
HIPAA Compliance
Risk Management
Document Control
Archiving & Retention
Automated Routing
Change Management
Compliance Management
Electronic Signature
Periodic Review
Version Control
Escalation Management
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
Document Control
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
Auditing
Dashboard
Legal Risk Management
Reputation Risk Management