How Checkpoint Surgical Modernized Training and Document Control with Grand Avenue Software

Overview

Client Intro: Post-Market Nerve Care Innovator

Checkpoint Surgical is a leader in peripheral nerve care, offering intraoperative nerve stimulation technology that helps surgeons preserve and restore nerve function. As a post-market medical device company, maintaining strong compliance processes is essential. However, with a growing team and aging internal systems, their previous QMS no longer supported their operational needs.

The Problem: Outdated Systems and Manual Workflows

Checkpoint Surgical relied on a legacy, self-hosted QMS with limited functionality. The system frequently experienced uptime issues, prompting concerns about data loss. To reduce this risk, the team manually backed up documents to SharePoint—creating redundancy, but also more work.

Training was another major pain point. It was entirely paper-based and managed through email exchanges. A full-time employee was dedicated to tracking completions in a spreadsheet and distributing documents to a dispersed team of over 30 field reps across the U.S.

Key issues included:

• Server Reliability Risks: Concerns about downtime required backup processes.
• Manual Training Oversight: Time-consuming, spreadsheet and paper-based training management.
• Compliance Gaps: The system was not 21 CFR Part 11 compliant, creating audit risks.
• Resource Drain: Manual processes consumed valuable time from internal teams.

Checkpoint needed a modern, cloud-based QMS that could support their operations and ensure audit readiness.

The Solution: Implementing Grand Avenue Software

Checkpoint Surgical selected Grand Avenue Software for its simplicity, compliance focus, and ability to streamline both document control and training.

Reasons for selection included:

• Cloud-Based Infrastructure: Removed the need for internal servers or backup systems.
• Out-of-the-Box Compliance: Fully aligned with FDA 21 CFR Part 11 requirements.
• Electronic Training Module: Simplified training assignments and tracking for remote teams.
• User-Friendly Implementation: Intentionally chosen for its limited need for customization, allowing internal teams to manage implementation without outside consultants.
• Responsive Support: The Grand Avenue team responded to questions within 24 hours, keeping the project on track.

Implementation Approach

Checkpoint Surgical’s QA/RA team, led by Matthew Hildebrand, had experience with previous QMS migrations and was able to manage the project internally. The process was straightforward:

• Document Migration: Legacy files and backups were centralized in Grand Avenue, eliminating the need for SharePoint duplication.
• Training Profiles Setup: Role-based training profiles ensured consistency across departments and field teams.
• Efficient Rollout: The implementation was completed in under six months. Delays were minimal and mostly related to internal prioritization—not platform limitations.

Unlike previous systems, no consultants were needed—just clear guidance, strong internal ownership, and responsive support from the Grand Avenue team.

The Results: A Compliant and Efficient QMS

The shift to Grand Avenue Software brought immediate improvements in both efficiency and compliance:

• Streamlined Training: Training is now fully electronic and centrally managed. Employees receive assigned content automatically, and overdue items (if any) are easy to track.
• Audit Confidence: Demonstrating training status and document history during audits is now seamless—no more hunting for spreadsheets, paperwork, or backup files.
• Centralized Control: All documentation lives within one system, eliminating manual backups and scattered files.
• Resource Savings: Grand Avenue replaced the need for a full-time employee who previously managed training manually. According to Hildebrand, “This savings alone has more than paid for any costs with GAS.”
• Improved Access: Remote teams can access documents and complete training from anywhere, supporting Checkpoint’s distributed structure.

Conclusion: A Smarter, Simpler Way to Stay Compliant

Checkpoint Surgical’s move to Grand Avenue Software replaced risk-prone, manual processes with a modern, cloud-based QMS. The company now manages training, documents, and compliance with confidence and significantly less effort.

By choosing a scalable and intuitive system, Checkpoint didn’t just upgrade their QMS—they freed up resources, improved audit readiness, and gave their team more time to focus on innovation and patient outcomes.

For medical device companies looking for a simple, effective way to modernize their quality systems, Checkpoint’s experience proves that big results don’t have to come with a big learning curve—or big costs.