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Paper Systems Are the Riskiest Way to Manage Medical Device Projects

Paper systems are the riskiest way to manage medical device projects

Despite the number of options out there for managing documents and records, paper is (surprisingly) still one of the most common approaches for startup medical device companies. Of course, when I say “paper,” that includes physical paper or “digital paper” in the form of spreadsheets, Dropbox, or other general-purpose software tools. 

The problem with either approach is that they are both fraught with issues and introduce unacceptable business and product risks into your QMS. 

A paper-based QMS multiplies your risks

I’ve used paper-based approaches as well as other electronic document systems. And paper is by far the riskiest (and most expensive) way to manage medical device product development projects and quality systems.

Using paper means you will

  • Have missing documents and records. I can promise you that. You will have times when  critical, must-have documents you need as objective evidence are lost, never to be found.
  • Use documents and records that are out of date. Managing document revisions in a paper world is an absolute nightmare. As documents are revised repeatedly, the risk of an old version surviving and being used continues to climb. At a certain point, it becomes nearly impossible to ensure that the correct revisions of all your documents are kept and maintained everywhere.
  • End up missing reviews and approval signatures on essential documents. With paper, you need to have actual “wet” signatures or a separate, Part 11-compliant method for electronic signatures. I can guarantee that you will have documents with missing signatures if you’re tracking them manually on paper or general-purpose software.

And the worst part about all of these issues? You probably won’t know they exist until the worst possible time: during an audit or inspection. You’ll be asked to pull a specific document and you’ll immediately see that it’s missing a signature or it’s an older version that should have been replaced. And so will the auditor. 

Audit findings are expensive and time-consuming to rectify—ask anyone who’s been under a warning letter how many years that cost their company. Even relatively minor findings can set you back, and that can be extremely risky for a smaller company without an enormous financial runway to work with. 

So, whether we’re talking about managing product development or managing business risk, paper really is the riskiest way to manage your medical device projects.

Fortunately, there are ways to eliminate the risks of paper altogether.

The best way is to implement a solution that allows you to efficiently manage all your documents and records and ensure they’re up-to-date for audits or inspections. I’m referring, of course, to Greenlight Guru Quality, a QMS solution specifically designed for medical device companies like yours. 

Here’s what that means in practice:

Store and manage all your documents in a single system

Paper remains popular today because of the perception that using paper to manage your company’s QMS is easier than the other alternatives available to you.

And for most solutions, there’s probably some truth to that. Many QMS solutions serve any number of different industries—pharma, automotive, aerospace, or cannabis, just to name a few. They have to be industry-agnostic at first, and then heavily customized to fit each company. 

At Greenlight Guru, we decided to serve one industry—MedTech—and that’s what we’ve done for more than a decade. Instead of heavy customization and validation, we offer a QMS solution that comes with medical device-specific features already built in. 

So you’ll always have a single source of truth for your documents and records, with Part 11-compliant e-signatures and revision control that comes standard. 

Designed specifically for the needs of medical device companies to meet 21 CFR Part 820 and ISO 13485:2016 requirements for document control and records management, we’ve worked to make the decision to switch from paper as easy as possible. 

No more trying to track down which desk has your critical document buried in a random pile. Or worse yet, wondering if the VP took that record you need approved with him on his two-week business trip.

Ensure all revisions are maintained

Stop worrying about where each and every revision–current or past–is located or if you don’t have them.

Greenlight Guru allows you to store every single revision of every single document and record. You’ll always know which version is current and published, and you’ll have access to the entire trail of past versions of each document—complete with approvals and training records.

Never let a signature slip through the cracks

Year after year, missing approval signatures on documents is one of the most consistent issues that FDA inspectors and ISO auditors run into. If that’s surprising, then you probably aren’t using paper to manage your QMS. 

To stay compliant, documents have to be reviewed and approved by the specified individuals within your organization before they’re implemented. Manually tracking down people within a company and then making sure they’ve signed a document is painstaking and error-prone work. 

Because all your documentation lives within a single system, Greenlight Guru Quality is able to prevent publication of a document until it’s been approved and signed. You’ll also be able to send reminders and view the status of the document in a simple, intuitive user interface. 

That’s a far cry from filing cabinets or endless columns on an Excel spreadsheet

Always audit ready

A lot of folks seem to believe that an FDA inspection or ISO audit simply won’t happen to them. Or, even if it does, they’ll be able to manage and play catch up before the inspection. 

But remember, FDA is mandated to conduct onsite inspections of all medical device companies with a class II or class III product at least once every two years. The agency is also under no obligation to tell you when they are coming. 

If you have an interest in selling products outside the U.S., chances are you are considering ISO 13485 certification. In order to get that certification, you willinging inviting an outside audit team into your facility on an annual basis (and maybe more frequently). 

In other words, inspections and audits are part of doing business in the MedTech industry. These periodic reviews of your documents, records, and facility are meant to ensure that you have objective evidence that your company is following the applicable regulatory requirements and your established procedures. 

Given that you can be sure these events will happen, having a document management system in place that is always ready for inspections and audits is a no-brainer.

 

Greenlight Guru Quality gives you the tools you need to leave paper behind once and for all

If you take one thing from this article, let it be this: using a paper-based QMS is playing with fire. It may seem easier when you compare it to some of the solutions out there, but it is dangerous. 

We built Greenlight Guru Quality so MedTech companies could switch from paper with confidence. Instead of wondering if your new QMS solution is even more complicated than paper, you now have the option of a simple, secure, and compliant QMS system that was purpose-built for your needs. 

If you want to learn more about how Greenlight Guru Quality makes it easier than ever to let go of paper, then get your free demo of our software here→