The Importance of Maintaining Documentation in the Medical Device Industry

The medical device industry is one of the most highly regulated industries in the world. This implies that organizations in this industry must have a solid document management system in place to ensure regulatory compliance. Documents and records demonstrate that your firm adheres to legal document management standards when designing, producing, and manufacturing products. We'll talk about the significance of documenting medical device production in this blog post, as well as give recommendations on how to do it effectively.

That's why it's critical to consider how your firm will handle all of its documents and records now, as well as in the future.

Three key ideas for thinking about when creating a system for managing the documentation that works for you and your team.

TIP #1: DEVELOP A DOCUMENT MANAGEMENT PLAN

Develop a document management plan as soon as possible. To begin, make a list of all the documents you need to manage.

Map out all the varieties of papers and records that will be generated throughout medical device product development.

Remember, according to FDA and other regulatory bodies, if you didn't write it down, it didn't happen. Consider how you'll capture proof of completing the various QMS tasks as planned, particularly if you're new to this process.

You must document, for example, your design and risk management activities throughout product development. A Design History File (DHF) is required to preserve related documents or make them available.

You'll also need to select a few suppliers. You're also likely working with a number of suppliers. Consider supplier evaluation records, qualification records, and an Approved Supplier List, to name a few.

You may also define manufacturing processes and create Device Master Records, which is the "recipe" for your organization's devices.

Let me be honest with you: once you go to market, you have a lot of production and post-production documentation and records to think about. The following are some examples of things you can do with a Roth IRA:

• Repository of all previously saved documents and emails.
• Customer feedback and complaints
• Corrective Actions
• Non-conformances
• Change Orders

We're just scratching the surface. Once again, you'll need to spend some time researching and containing the documents and records you'll need to generate and maintain.

When it comes to selecting the sort of papers and records you'll retain, there are a few more variables to consider when creating an efficient document management plan:

• Determine who the document and record's rightful owner is. Do this as soon as possible to avoid any confusion. When you don't know who the document owner should be, problems will almost certainly develop down the road. Make these decisions when your system is at its most adaptable.
• Determine how long you'll need to store all of this information.
• Determine where you'll store your records and how they will be maintained (see Tip #2).
• Consider how things will change over the next five years. This entails taking into account scalability and adaptability in your plan.

Finally, be sure to keep essential stakeholders informed as you develop your document management plan. Getting them on board early is critical.

Even if your firm already has a set of procedures, it's worth considering whether the current document management strategy is appropriate.

TIP #2: THE USE OF PAPER-BASED SYSTEMS MUST

Did you know that over half of medical device firms are still using paper-based document management systems?

Electronic document management systems have a lot of benefits that even the youngest medical device company can benefit from.

Why are so many medical device businesses still using document management software that doesn't work for them?

Do you feel that general purpose applications like Dropbox and Google Drive can "fulfill" your document management requirements?

Do you truly like keeping track of all that paperwork?

I'm guessing it's because people think paperless document management systems are too expensive.

OK, I'll grant that most document management systems aren't actually given away. In order to implement office scanning solutions, you will have to spend some funds.

Look at it another way:

It's increasingly obvious that document management solutions if your document controller makes $60,000 a year but spends 20% of her time-fighting non-conforming documents and complicated management software to just have the next surveillance audit produce a stack of CAPAs with document and record management concerns.

• They will pay for themselves very quickly. (It's easy to do so, so go ahead and do it.)
• Raise employee morale ("What? I don't have to spend my afternoon chasing people for approval signatures??? YEAH!")
• Reduce regulatory non-conformity (not only on the documentation side. You'll have more time to focus on other areas of concern while preparing for audits if you spend less time repairing documents.)
• Work from the bottom up to free your staff in order for them to use their brains on the issues that truly matter (chasing missing records does not qualify)
• Is it preferable to address the majority of document and record-oriented non-conformities (for example, "A previous edition was lost? Hmmm, perhaps our "Document Control Made Easy in 1.5 Billion Steps" training program's quiz needs to be revalidated,") by correcting or submitting a change request to the source?
• Enhance your security (consider audit trails, electronic signatures, and access logs)

Of course, there are always outliers. Despite all of the features, the electronic document management system for medical industry you pick may turn out to be a dud.

Make sure you have the right person with the right document management expertise on hand to ask the appropriate questions when looking for the best document management system.

As you are aware, the FDA's 21 CFR Part 820 and ISO 13485 have strict document-keeping requirements. As a result, please ensure that the solution you select is developed with these criteria in mind.

 

TIP #3: FOLLOW THE DOCUMENT MANAGEMENT PROCEDURES

Sure, this advice appears to be straightforward. Certainly, you will follow your own record-keeping and documentation procedures!

Despite your best efforts, they will occasionally be derailed.

Make sure your medical device firm follows formal processes. Make certain that the procedures being followed by your company are valid and legal.

I can promise you that if the FDA or an ISO auditor audits you, they will look for objective proof.

OK, document management isn't exactly exciting. Nonetheless, document management is the basis of your med device firm's infrastructure.

Internal auditing is one approach to help you figure out whether established methods are being followed. Internal auditing is a method of self-policing and making sure that documents and records exist. It's also a legal duty.

Yes, difficulties will arise once your quality system procedures are put into place, no matter how good your plan is or how well-written your processes are.

Adjustments should be made when this happens.

Continuous improvement is a must.

Finally, purchase a document management solution that will relieve you of the burden of document management software for medical industry.

This co-authored post originally appeared on Quality Digest as a guest contribution, and it is being republished here with permission.