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What is Worksmart?

We leverage our vast knowledge in Financial Services alongside a dedicated focus on developing solutions that optimize both time and resources while supporting necessary regulatory changes. Our offerings feature a range of award-winning RegTech tools, all grounded in a deep understanding of market dynamics and regulatory perspectives. Whether addressing Training & Competence (TC), Quality Assurance (QA), the Senior Managers & Certification Regime (SMCR), or Complaints Management, we aim to bolster your Governance, Risk, and Compliance initiatives. As the realm of advisory and process management increasingly transitions to digital platforms, it becomes essential for regulated entities to swiftly adapt to the rapidly evolving market landscape. Furthermore, it is widely acknowledged that critical roles within regulated firms must comply with the FCA’s Training and Competence (T&C) regulations, which have been integral to the financial services industry for decades and a regulatory requirement since the 1990s. In this continuously changing climate, maintaining a proactive stance on compliance obligations is more important than ever, ensuring that organizations can navigate challenges effectively and remain competitive.

What is Grand Avenue Software?

An online software solution tailored for medical device manufacturers that streamlines their operations and eases adherence to regulatory standards. This suite features modules such as Audit Management, Corrective and Preventive Actions (CAPA), and Complaint Handling. It has been specifically developed to ensure compliance with ISO 13485 and 21 CFR Part 11 from the outset, providing a robust framework for quality management. Additionally, its user-friendly interface allows companies to efficiently navigate complex compliance requirements while maintaining high standards of product safety and effectiveness.

Media

Media

Integrations Supported

Additional information not provided

Integrations Supported

Additional information not provided

API Availability

API Availability

Has API

Pricing Information

Pricing not provided

Pricing Information

Pricing not provided
Free Trial Offered?

Supported Platforms

SaaS

Supported Platforms

SaaS

Customer Service / Support

Standard Support
Web-Based Support

Customer Service / Support

Standard Support
Web-Based Support

Training Options

Documentation Hub
Webinars

Training Options

Documentation Hub
Webinars
Online Training

Company Facts

Organization Name

Worksmart

Date Founded

1997

Company Location

United Kingdom

Company Website

www.worksmart.co.uk

Company Facts

Organization Name

Grand Avenue Software

Date Founded

2002

Company Location

United States

Company Website

www.grandavenue.com

Categories and Features

Complaint Management

Not specified

Categories and Features

Calibration Management

Calibration Instructions
Calibration Schedules
Due Date Tracking

CAPA

Audit Management
CAPA Planning
Change Management
Complaint Management
Incident Management
Nonconformance Tracking
Quality Control
Training Management

Change Management

Approval Workflow
Audit Trail
Release Management
Task Management
Training Management

Complaint Management

Complaint Classification
Corrective Actions (CAPA)
Customer Complaint Tracking
Issue Tracking
Quality Assurance Management
Routing

Document Version Control

Access Controls/Permissions
Approval Process Control
Audit Trail
Revision History

Equipment Management

Not specified

Preventive Maintenance

Maintenance Scheduling
Reminders

Quality Management

Audit Management
Complaint Management
Compliance Management
Corrective and Preventive Actions (CAPA)
Defect Tracking
Document Control
Equipment Management
Maintenance Management
Risk Management
Supplier Quality Control
Training Management

Vendor Management

Audit Management
Vendor Qualification Tracking

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