Average Ratings 0 Ratings
Average Ratings 0 Ratings
Description
Based on the BRCGS Global Standards, the assessment involves evaluating each section and clause by asking multiple questions, which are to be answered with Yes (indicating compliance), No (indicating non-compliance), or N/A (not applicable). Any areas of non-compliance are flagged when questions receive a No response. Each question allows for comments and references to pertinent documents, such as policies, and provides space for additional notes. In the case of non-conformances, actions can be initiated, with assignments given to responsible individuals, deadlines established, and verifiers designated for completion. Users can delve deeper into each identified gap to track actions taken, who is responsible, and the current status of those actions. Additionally, it's essential to keep a comprehensive history log and audit trail for all audits and actions pertaining to the BRCGS Global Standard clauses. It is also crucial to periodically review the gap analysis whenever there are changes in processes or products to ensure ongoing compliance. Regular updates and assessments will help maintain alignment with the standards and improve overall operational integrity.
Description
A web-based software suite for medical device companies that automates their processes and simplifies regulatory compliance. Modules include Audit Management, CAPA and Complaint Handling. Designed from the start for ISO 13485 compliance and 21 CFR Part 11 compliance.
API Access
Has API
API Access
Has API
Integrations
No details available.
Integrations
No details available.
Pricing Details
$20.16 per user per month
Free Trial
Free Version
Pricing Details
No price information available.
Free Trial
Free Version
Deployment
Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook
Deployment
Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook
Customer Support
Business Hours
Live Rep (24/7)
Online Support
Customer Support
Business Hours
Live Rep (24/7)
Online Support
Types of Training
Training Docs
Webinars
Live Training (Online)
In Person
Types of Training
Training Docs
Webinars
Live Training (Online)
In Person
Vendor Details
Company Name
BRC Compliance Solution
Country
United kingdoms
Website
brccompliance.org/brc-gap-analysis/
Vendor Details
Company Name
Grand Avenue Software
Founded
2002
Country
United States
Website
www.grandavenue.com
Product Features
Compliance
Archiving & Retention
Artificial Intelligence (AI)
Audit Management
Compliance Tracking
Controls Testing
Environmental Compliance
FDA Compliance
HIPAA Compliance
ISO Compliance
Incident Management
OSHA Compliance
Risk Management
Sarbanes-Oxley Compliance
Surveys & Feedback
Version Control
Workflow / Process Automation
Product Features
Calibration Management
Calibration Instructions
Calibration Schedules
Compliance Management
Device History
Due Date Tracking
Gage Management
Label Printing
Measurement Readings
Multi-Station Management
Out-of-Tolerance Notification
Statistical Data Reporting
CAPA
Audit Management
CAPA Planning
Change Management
Complaint Management
Incident Management
Nonconformance Tracking
Quality Control
Risk Management
Root Cause Analysis
Training Management
Change Management
Approval Workflow
Audit Trail
Automated Notifications
Change Calendar
Change Planning
Compliance Management
Prioritization
Release Management
Task Management
Tracking & Reporting
Training Management
Complaint Management
Case Management
Complaint Classification
Corrective Actions (CAPA)
Customer Complaint Tracking
Feedback Management
Forms Management
Issue Tracking
Quality Assurance Management
Routing
Self Service Portal
Social Media Monitoring
Survey 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
Preventive Maintenance
Condition Monitoring
Inspection Management
Maintenance Scheduling
Mobile Access
Predictive Maintenance
Purchasing
Reminders
To-Do List
Vendor Management
Work Order Management
Quality Management
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
Vendor Management
Audit Management
Contact Management
Customer Database
Self Service Portal
Supplier Master Data
Transaction History
Vendor Maintained Profiles
Vendor Managed Inventory
Vendor Performance Rating
Vendor Qualification Tracking