Reading the Water: Navigating What Matters in Regulatory and Quality

Many small companies start their quality system the same way. They buy an SOP pack. Or they sign up for a popular eQMS marketed to startups and turn on the starter set that comes with it. It feels efficient. It feels like progress.

Much of the time, it creates a different problem.

Those systems are usually built to work for everyone. That means they rarely fit anyone especially well. For a small company, they are often too complex. For a larger company with a more complicated product, they may not go far enough.

The bigger issue is that most companies using those systems are not in a position to tell the difference. They do not know whether a given procedure reflects an actual requirement or just one company’s preferred way of meeting that requirement.

I saw this often when I was in the FDA. Some of the companies with the most resources still ended up in trouble, not because they ignored quality, but because they built systems they could not actually run.

One example that stuck with me was training. Under the old QSR, the training requirement itself was less than a paragraph. This company turned it into a nine-page procedure and built it into a complex custom LMS. On paper, it looked robust. In practice, it did the opposite of what it was supposed to do.

When I brought in the manager and asked a basic question, who is qualified to perform which job, she could not answer it clearly. She could not tell me what record she used to confirm that an employee was qualified. At the time, we could not even say with confidence whether the person running release QC testing was actually qualified to run that test.

That is the problem with overbuilt quality systems. They create activity without creating control.

A lot of young companies assume the safest thing to do is write more. More SOPs. More approvals. More workflow. More software.

That is not the same thing as having a stronger quality system.

A good quality system should do three things. It should meet the requirements. It should fit the company. It should be something the team can actually use and maintain.

This is where founders usually need help. Not because they are incapable of running quality, but because they need someone to separate what is required from one possible way of meeting the requirement. There is usually more than one acceptable way to build a compliant system.

The right quality system is not the biggest one. It is the one the company can live with, scale with, and defend when it matters.

You do not need the biggest boat in the marina. You need one you can actually run, maintain, and trust when the water gets rough.

If you'd like to learn more from Sam about quality systems for your novel medical technology compay, please contact us.

Sam Murray

Head of Regulatory & Quality