How Intricon Replaced Paper-Based QMS Processes with Grand Avenue Software

Overview

Client

Intricon

Products

Contract manufacturing services for medical device companies

Challenge

Paper-based and fragmented systems for NCMRs, CAPAs, and supplier management led to process delays, limited visibility, and audit risks

Solution

Migrated to Grand Avenue Software’s cloud-based eQMS using minimal customization and leveraging out-of-the-box functionality

Results

Greater visibility into task status, easier DCR workflows, improved ASL management, and a foundation for measurable quality improvements

Client: Intricon
Products: Contract manufacturing services for medical device companies
Challenge: Paper-based and fragmented systems for NCMRs, CAPAs, and supplier management led to process delays, limited visibility, and audit risks
Solution: Migrated to Grand Avenue Software’s cloud-based eQMS using minimal customization and leveraging out-of-the-box functionality
Results: Greater visibility into task status, easier DCR workflows, improved ASL management, and a foundation for measurable quality improvements

Client Intro: Trusted Medical Device Manufacturer

Intricon is a contract manufacturer serving top-tier medical device companies. Although they do not produce finished devices, maintaining strict quality control and ISO 13485:2016 compliance is critical to their business. As a manufacturing partner, Intricon must meet the same rigorous standards as their OEM customers—making an effective and efficient QMS a non-negotiable requirement.

The Problem: Paper-Based Workflows and Limited Visibility

Before implementing Grand Avenue Software, Intricon relied on paper-based routing and siloed tools to manage core quality processes such as NCMRs and CAPAs. This created several operational challenges:

  • Manual Routing Delays: NCMRs were routed by hand, slowing down approvals and increasing the risk of losing documents.
  • Cumbersome CAPA Tracking: CAPAs were managed via DocuSign, which made it difficult to maintain a clear, auditable record of actions taken.
  • Lack of Transparency: Teams had no visibility into the status of open quality tasks, which complicated decision-making and slowed down resolution timelines.

With their business growing and the stakes for compliance rising, Intricon needed to replace their patchwork system with a modern, scalable solution.

The Solution: Deploying Grand Avenue’s eQMS

Intricon selected Grand Avenue Software based on its user-friendly design, proven support team, and ability to simplify ISO 13485:2016 compliance. The implementation approach focused on speed, simplicity, and long-term scalability.

Why Grand Avenue?

  • Out-of-the-Box Simplicity: Most functionality was used without customization, minimizing complexity.
  • Responsive Support: Grand Avenue’s support team was quick to respond and provided effective, feasible solutions throughout the process.
  • Implementation Tools: Built-in tools made it easy to upload and transition data from legacy systems.
  • Cost-Effective Compliance: The platform offered all essential modules to move from a paper-based system to a fully electronic QMS.

Implementation Approach

Intricon led the rollout internally, with support from an experienced Grand Avenue implementer to accelerate configuration and validation. Key highlights include:

  • Minimal Customization: Intricon used the platform largely as-is, with only a few simple adjustments when needed.
  • Streamlined Validation: Grand Avenue’s pre-built validation package saved time and helped satisfy regulatory expectations quickly.
  • Smooth Supplier List Migration: The Approved Supplier List (ASL) was centralized in Grand Avenue, becoming a single source of truth for the organization.

“Whenever support was needed from the Grand Avenue team, they were quick to respond, provided feasible solutions, and provided great guidance along the way.”
— Craig Sandbulte, Intricon

The Results: A More Transparent and Manageable QMS

While implementation is still early, Intricon is already experiencing tangible benefits:

  • Better Visibility: Teams can view dashboards and run reports to monitor task progress, eliminating guesswork.
  • Improved Workflows: Document Change Requests (DCRs) are easier to complete and more consistent thanks to built-in guidance.
  • Supplier List Management: The ASL is easier to update and accessible across the organization, providing clarity and control.

“GAS walks the preparer through the necessary steps and helps ensure all the required information is included,” said Craig Sandbulte. Intricon expects to establish performance baselines using Grand Avenue’s reporting capabilities and will use those metrics to drive future improvements.

Conclusion: A Practical Path to Paperless Compliance

Intricon’s move to Grand Avenue Software marked a major step forward in modernizing their QMS. By transitioning away from paper and manual routing, the team gained control, transparency, and a scalable system to support future growth.

For companies seeking an easy-to-implement, cost-effective eQMS with best-practice workflows built in, Intricon’s story offers a clear roadmap—and a strong endorsement.

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