From paper to a quality system that runs itself: how BioRESEARCH modernized with Greenlight Guru

Who is BioRESEARCH Associates?

BioRESEARCH Associates is a Wisconsin-based manufacturer of diagnostic and monitoring devices for the dental and craniofacial field, best known for its biometric systems for evaluating temporomandibular joint, or TMJ, function. The company is a small, close-knit team that manages its full quality system in-house, and it operates under MDSAP, the Medical Device Single Audit Program.

The challenge: proving compliance on a paper system

For years, BioRESEARCH ran its quality system on paper, organized through Microsoft SharePoint file folders, which could create friction during audits. Auditors always asked the same question: how do you document approvals? And every time the team would have to walk the auditor through their process for review, approval, and publication.

The old change process made that worse. Any document revision went through the same engineering change notice workflow the company used for changes to the device itself, which was far more tedious than the task required. Tracing the history of a change was difficult, and proving the current status of a document required explanation rather than a single screen.

The solution: a right-sized eQMS built for medtech

For a small team that wears a lot of hats, the deciding factor for BioRESEARCH was that Greenlight Guru fit the team’s current size, but was ready to grow with them if they expanded.

What sold the team was the combination of features built for how it actually works: role-based permissions on documents, the Greenlight Guru Academy for internal training, integrated software validation, and the ability to create training groups so that assigning someone to a group automatically applies the right training requirements.

Implementation went smoothly, and much of that came down to how much the team could handle on its own. BioRESEARCH leaned on Greenlight Guru Academy to get up and running, using the self-paced courses to walk through setup and day-to-day use of the system.

The main concern going in was uploading documents, specifically how to handle the bulk upload of historical records. BioRESEARCH resolved it pragmatically by relying on tags, keeping some older material as paper records, and bulk-uploading the rest through the zip file process, with support from Greenlight Guru on the record uploads in the later phases of the rollout.

The results: faster audits and less system maintenance

BioRESEARCH has been through several external MDSAP audits and multiple internal audits using Greenlight Guru, and the difference from its paper days shows up most clearly in the audit room. Where pulling documents from SharePoint folders once meant searching through file structures, the team's tag setup now makes it simple to pull records on request. Auditors have commented positively on how quickly such a small team produces what they ask for, and they follow the risk matrices and CAPA records easily.

Less time maintaining the system and more time using it

The clearest sign of the change is where the team's time goes. When Carl started, the quality system was still in its infancy and demanded most of the team's attention in order to both maintain it and build it out at the same time. With the system settled in Greenlight Guru, that maintenance load has dropped sharply.

A change process built for the work

Several capabilities drive those time savings. The change order workspace removed the need to run document changes through the old engineering change notice process. The compare-documents feature lets Carl review administrative edits without reading every line, which has cut his review time on minor change orders. And customizable change order evaluation forms let the team build audit-driven requirements directly into the evaluation rather than uploading an external form.

Risk and CAPA in one place

The harms database and integrated benefit-risk analysis in Greenlight Guru replaced what used to be a tedious spreadsheet, and traceability now lives inside the risk record itself. The CAPA workflow is another of the team’s favorite workspaces. Documenting a corrective or preventive action no longer means working through an extremely long form, and adding an audit response into the CAPA module after it has been written and approved is far simpler than the old approach. The team has also used Greenlight Guru for its design work, including the documentation behind a new product the company recently brought to market.

Design controls behind a new product release

With the quality system settled, BioRESEARCH hit a milestone that had been a long time coming. The company brought its first newly developed product to market in 13 years, and it managed the design documentation for that product in Greenlight Guru. Carl called the platform "very helpful for design" and for keeping records current, so the team could see exactly what had been published and when.

Why BioRESEARCH continues to choose Greenlight Guru

BioRESEARCH stays with Greenlight Guru for its combination of steady support, regular check-ins, and a system the team has been able to make its own. The recurring customer meetings give the team a chance to talk through their next goals, and the templates for SOPs and work instructions gave a first-time quality lead a set of rails to work from without locking the team into someone else's process.