From paper to a clean FDA inspection: Putnam Medical's switch to Greenlight Guru

Who is Putnam Medical?

Putnam Medical is an FDA-registered contract manufacturer of finished medical devices, offering a one-stop path from development through packaging and preparation for sterilization. The company develops and manufactures advanced technology solutions for minimally invasive, life-saving devices, with capabilities that range from precision machining, laser welding, and catheter shape setting to braid reinforcement, balloon forming, and steerable catheter assembly, carried out in ISO Class 7 certified clean rooms.

Putnam Medical is built on more than 40 years of industry leadership through its association with Putnam Plastics. As a contract manufacturer, the company builds to its customers' specifications rather than under its own brand, serving both startups and established global medical device companies. A dedicated quality assurance and regulatory affairs team maintains ISO 13485 certification and works closely with each customer to tailor solutions for their product.

Holly Opalenick leads that function as Quality Assurance and Regulatory Affairs Manager and serves as the company's management representative. Her scope runs broad by design at a small company, covering supplier management, audits, CAPA, and overall quality assurance.

The FDA inspection: zero findings, no scramble

Putnam’s regulatory discipline, and Greenlight Guru’s eQMS, were put to the test during an audit just after the QMSR effective date. The notice arrived on a Friday and the inspection occurred just days later. But instead of a fire drill with everyone working over the weekend, the team simply printed a short set of logs.

When the investigator arrived, the team could pull the records she asked for immediately. She reviewed most of them on screen rather than in print, and for the handful printed on the spot, the system's stamp showed they came straight from the current record without editing. The inspection closed with no findings and no establishment inspection commentary.

The challenge: proving current records in a paper-based QMS

In Putnam’s old paper system, finding a record meant building in redundancy. Teams kept multiple copies filed in multiple folders so that a document could be located again later.

Another issue the team struggled with before Greenlight Guru was proving training currency. Confirming who was trained on which version of a document, and when, meant reconstructing the picture by hand. Holly recalls tracking training the old way at previous companies, working through spreadsheets and paper folders to answer a question the system now answers on its own.

The solution: an eQMS that lets users find records instantly

Greenlight Guru’s eQMS gave Putnam the structure they needed to build a naming system that let them retrieve documents instantly. The system presents a small set of document types up front, and rather than working against Putnam Medical's processes, that structure prompted the team to sharpen its own definitions.

For example, when Holly went looking for a separate document type for specifications and found the system pointed her elsewhere, it led the team to clarify that nearly every specification originates with the customer and therefore lives as a record, not a Putnam-owned document. That distinction carried through into cleaner customer quality agreements.

The searchability in Greenlight Guru also changed the daily experience of the system. With a simple naming convention built around part and product numbers, a search that once meant sorting through thousands of records is now quick and easy.

The results: simplified training and a system that scales

Training used to be one of the heaviest manual burdens on the quality team. But with Greenlight Guru, training compliance can run in the background without continuous monitoring. Now a single view shows who is trained on the current version of any document, which removes the hunt through folders and spreadsheets entirely. New operators with no prior eQMS experience complete their training requirement in one session, and the ease of the workflow has won over colleagues outside quality, including the IT administrator who approves the company's software validation procedure.

A system that scales with the record count

When Putnam Medical built its system on a few hundred documents, the team wondered whether it would hold up as the record count grew. It has since migrated its full set of legacy records and now runs several thousand records in Greenlight Guru without a drop in performance.

Why Putnam Medical stays with Greenlight Guru

For Holly, the decision to stay comes down to a system she trusts to find what she needs, when she needs it. She points to the up-front work of learning the system and setting a clear naming convention as the effort that pays off every day after, and to the searchability that turns an audit from a scramble into a routine.

As Putnam Medical grows its specialized technology work, the quality function has room to grow with it, and the team continues to extend how it uses the system across the business. What started as a move off paper has become the backbone of a quality operation that faces an FDA investigator with nothing to reconstruct and nothing to fear.