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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.

Description

To enable your employees to reach their full potential, it is essential to implement an effective corrective action process that addresses performance issues proactively. Many organizations today face difficulties due to inconsistent procedures, insufficient oversight, and a disconnect in managing employee corrective actions. The PCA software effectively addresses these obstacles, allowing your team to concentrate on fostering a positive culture, enhancing teamwork, increasing efficiency, and optimizing costs. Tailored to fit your organization's unique processes and requirements, the PCA solution empowers designated Super Users to establish customized flows and routing. Additionally, PCA seamlessly integrates with popular HR systems such as SAP, PeopleSoft, and Workforce, ensuring a secure one-way data transmission that protects your HR infrastructure. By consolidating your company policies, procedures, and standard operating protocols into a centralized automated platform, PCA shifts the focus back to addressing issues rather than getting bogged down by the process itself. This innovative approach not only streamlines operations but also promotes a more engaged and productive workforce.

API Access

Has API Yes 

API Access

Has API No 

Screenshots View All

Screenshots View All

Integrations

Oracle PeopleSoft No 
SAP SuccessFactors No 

Integrations

Oracle PeopleSoft Yes 
SAP SuccessFactors Yes 

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 No 
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 Yes 
Live Rep (24/7) No 
Online Support No 

Types of Training

Training Docs Yes 
Webinars Yes 
Live Training (Online) Yes 
In Person No 

Types of Training

Training Docs Yes 
Webinars No 
Live Training (Online) Yes 
In Person Yes 

Vendor Details

Company Name

Grand Avenue Software

Founded

2002

Country

United States

Website

www.grandavenue.com

Vendor Details

Company Name

HR Efficient

Country

United States

Website

hre.solutions

Product Features

Calibration Management

Calibration Instructions Yes 
Calibration Schedules Yes 
Compliance Management No 
Device History No 
Due Date Tracking Yes 
Gage Management No 
Label Printing No 
Measurement Readings No 
Multi-Station Management No 
Out-of-Tolerance Notification No 
Statistical Data Reporting No 

CAPA

Audit Management Yes 
CAPA Planning Yes 
Change Management Yes 
Complaint Management Yes 
Incident Management Yes 
Nonconformance Tracking Yes 
Quality Control Yes 
Risk Management No 
Root Cause Analysis No 
Training Management Yes 

Change Management

Approval Workflow Yes 
Audit Trail Yes 
Automated Notifications No 
Change Calendar No 
Change Planning No 
Compliance Management No 
Prioritization No 
Release Management Yes 
Task Management Yes 
Tracking & Reporting No 
Training Management Yes 

Complaint Management

Case Management No 
Complaint Classification Yes 
Corrective Actions (CAPA) Yes 
Customer Complaint Tracking Yes 
Feedback Management No 
Forms Management No 
Issue Tracking Yes 
Quality Assurance Management Yes 
Routing Yes 
Self Service Portal No 
Social Media Monitoring No 
Survey Management No 

Document Version Control

Access Controls/Permissions Yes 
Approval Process Control Yes 
Archiving & Retention No 
Audit Trail Yes 
Commenting / Notes No 
Document Check-in / Check-out No 
For Engineering Documents No 
Revision History Yes 
Version Comparison No 
Version Rollback No 

Preventive Maintenance

Condition Monitoring No 
Inspection Management No 
Maintenance Scheduling Yes 
Mobile Access No 
Predictive Maintenance No 
Purchasing No 
Reminders Yes 
To-Do List No 
Vendor Management No 
Work Order Management No 

Quality Management

Audit Management Yes 
Complaint Management Yes 
Compliance Management Yes 
Corrective and Preventive Actions (CAPA) Yes 
Defect Tracking Yes 
Document Control Yes 
Equipment Management Yes 
ISO Standards Management No 
Maintenance Management Yes 
Risk Management Yes 
Supplier Quality Control Yes 
Training Management Yes 

Vendor Management

Audit Management Yes 
Contact Management No 
Customer Database No 
Self Service Portal No 
Supplier Master Data No 
Transaction History No 
Vendor Maintained Profiles No 
Vendor Managed Inventory No 
Vendor Performance Rating No 
Vendor Qualification Tracking Yes 

Product Features

CAPA

Audit Management Yes 
CAPA Planning Yes 
Change Management Yes 
Complaint Management Yes 
Incident Management Yes 
Nonconformance Tracking No 
Quality Control Yes 
Risk Management Yes 
Root Cause Analysis No 
Training Management No 

Compliance

Archiving & Retention No 
Artificial Intelligence (AI) No 
Audit Management No 
Compliance Tracking Yes 
Controls Testing No 
Environmental Compliance No 
FDA Compliance No 
HIPAA Compliance No 
ISO Compliance No 
Incident Management Yes 
OSHA Compliance No 
Risk Management Yes 
Sarbanes-Oxley Compliance No 
Surveys & Feedback No 
Version Control No 
Workflow / Process Automation Yes 

Financial Risk Management

Compliance Management Yes 
Credit Risk Management No 
For Hedge Funds No 
Liquidity Analysis No 
Loan Portfolio Management No 
Market Risk Management No 
Operational Risk Management Yes 
Portfolio Management No 
Portfolio Modeling No 
Risk Analytics Benchmarks Yes 
Stress Tests No 
Value At Risk Calculation No 

Human Resources

360 Degree Feedback No 
Applicant Tracking No 
Attendance Management No 
Benefits Management No 
Career Development Planning No 
Compensation Management No 
Compliance Management No 
Employee Database No 
Employee Lifecycle Management No 
Onboarding No 
Payroll Management No 
Performance Management Yes 
Recruiting Management No 
Self Service Portal No 
Succession Planning No 
Time & Attendance Management No 
Time Off Management No 
Timesheets No 
Training Management No 

Incident Management

Audit Trail Yes 
Corrective Actions (CAPA) Yes 
Disaster Recovery No 
IT Incident Management No 
Incident Reporting Yes 
OSHA Compliance No 
Root-Cause Diagnosis No 
Safety Management Yes 
Task Management Yes 
Ticket Management No 

Legal Case Management

Billing Management No 
Calendar Management No 
Case Notes Yes 
Client Management No 
Communication Tracking No 
Conflict Management Yes 
Corporations No 
Court Management No 
Discovery Management No 
Docket Management No 
Document Management Yes 
Expense Tracking No 
Government No 
Law Firms No 
Records Management Yes 
Task Management Yes 
Time Tracking Yes 
Trust Accounting No 

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