Zero findings on an MDSAP audit: how Molekule modernized quality after leaving a legacy PLM

Who is Molekule?

Molekule is a medical technology company that designs air purification devices for clinical and residential environments. Its purifiers pair true HEPA filtration and activated carbon with patented Photo Electrochemical Oxidation (PECO) technology, which uses light-activated catalysts to break down airborne pollutants such as bacteria, viruses, mold, and volatile organic compounds at the molecular level rather than simply trapping them.

Several Molekule devices are cleared by the U.S. Food and Drug Administration (FDA) as Class II medical devices under the 510(k) program, which puts the company squarely under FDA design control and quality system requirements. The quality team supports document control, training, supplier management, CAPAs, nonconformances, and design controls for products the company is bringing to market.

The challenge: moving on from a legacy QMS

Before Greenlight Guru, Molekule managed quality in a product lifecycle management platform built to serve many industries rather than medical device companies specifically. The team spent more time configuring the system to fit medtech work than getting value from it, and the documents and notifications were often difficult to find.

Audit preparation was also manual. The team worked from FDA audit checklists and had to go through the system to find each required SOP or record one at a time and put them into different folders.

According to Kara Baldwin, QMS Specialist at Molekule, when the team was ready to make a change, they looked for a user-friendly eQMS that wouldn’t require extensive customization to fit their needs. Kara had used Qualio in a previous role, and knew that wouldn’t have been the right fit for Molekule. “Qualio had a lot of extra information that wasn’t necessarily applicable to a medical device company.”

Instead, Molekule chose Greenlight Guru’s eQMS for its ease of use and focus on the medtech industry.

The solution: Greenlight Guru’s medtech-specific eQMS

Molekule has run on Greenlight Guru for four years now. Because the eQMS is purpose-built for medical device companies, the team did not have to assemble its own compliance framework, and training new users proved straightforward. The home dashboard and the search toolbar gave the team a single place to find work, with filters and tags that separate work instructions from standard operating procedures and other record types.

The team also moved repetitive quality processes into the background. Training requirements run automatically, and the team prepares change orders ahead of time rather than waiting on a strictly sequential review. That parallel way of working is a clear contrast with systems that force one document through review before the next can begin.

Traceability ties the system together. In CAPA and nonconformance work, the team can link audit reports directly to corrective actions and on to the verification and disposition activities that close them out. During the most recent audit, the ability to follow batch records all the way back through linked records proved decisive.

The results: zero findings and faster audit prep

Molekule has now been through three audits on Greenlight Guru. The most recent was an MDSAP audit with FDA, and the team closed it with zero findings. Reminders, prepared change orders, and the same filters and tags the team uses day-to-day made it easy to pull what auditors asked for and to reference SOPs on the spot.

Just as important, the work the team does has changed. Document management and organization now sit with the system, which has freed the quality function to focus on implementation and the substance of quality management rather than the mechanics of finding and moving files.

The benefit reaches beyond quality. According to Kara, the quality, operations, and engineering teams all rely on Greenlight Guru, from confirming that change orders are signed off and training is complete to giving engineers a clear path through design history and design review work for new products.

Why Greenlight Guru: medtech-specific and quick to implement

Molekule has never seriously considered switching from Greenlight Guru. Cost and functionality have both played a part, but the deciding factor is fit. A medtech-specific system gave the team enough structure to stay compliant with regulations without the excess of a general-purpose enterprise tool, and it connects to the other systems the team uses, including Jira and Tableau.

The team also leaned on Greenlight Guru Academy and the library of standard document templates and formats, resources that were especially useful for getting new team members up and running. Compared with the configuration burden the team carried in the old system, having those medtech-ready building blocks already in place removed a significant amount of setup work.

What's next for Molekule

Molekule is preparing to bring a new line of devices to market in October 2026, its first major product release in several years, with updated technology and materials. The design controls workspace in Greenlight Guru, including the design history and design review records the engineering team relies on, is supporting that launch. The team is also extending its use of the platform's automation and API connections to pull together data that has historically lived in separate systems.