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Description
BSI offers a comprehensive software solution, accessible both online and offline, that empowers organizations to disseminate essential information and resources, including policies, procedures, and guidelines. This platform facilitates the development, assessment, release, and updating of workplace documents, guarantees that employees can easily obtain the necessary information, and organizes meetings to minimize administrative burdens, ultimately enhancing operational efficiency.
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
Integrations
No details available.
Integrations
No details available.
Pricing Details
No price information available.
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
Yes
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)
No
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
BSI
Founded
1901
Country
United Kingdom
Website
www.bsi-entropy.com
Vendor Details
Company Name
Sierra Labs
Country
United States
Website
www.sierralabs.com/quality-management/
Product Features
Document Management
Access Controls
Yes
Archiving & Retention
Yes
Collaboration Tools
Yes
Compliance Tracking
Yes
Document Archiving
Yes
Document Assembly
Yes
Document Capture
No
Document Conversion
No
Document Delivery
Yes
Document Indexing
No
Document Retention
Yes
Electronic Signature
Yes
Email Management
Yes
File Recovery
Yes
File Type Conversion
Yes
Forms Management
No
Full Text Search
Yes
Offline Access
Yes
Optical Character Recognition
Yes
Print Management
No
Version Control
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
