Apr 20, 2021 Kelly Stanton

5 Amazing Medical Device Document Management Tips

What are the best medical device document management tips to help you improve organization and document procurement? 

Most growing startups know that document control is critically important—especially in highly regulated industries such as healthcare.

If you’re creating a document management system for your medical device organization, you’ve probably asked yourself the following: What medical device document management tips should I follow to streamline the entire process and develop a robust system?

As an industry-leading quality management system (QMS) provider, we’ve helped growing medical device organizations move from paper-based legacy systems to a powerful digital QMS. 

Beyond investing in a modern QMS, here is a list of the most important medical device document management tips to activate right now.

5 Important Medical Device Document Management Tips

Unfortunately, improper document management may result in serious compliance infractions. On the other hand, proper document management helps your organization:

  • Introduce strong identity and access management (IAM) processes, ensuring only authorized stakeholders have appropriate documentation access.
  • Streamline compliance under strict and evolving laws and regulations.
  • Improve search and retrieval of both active and archived documents.
  • Enable real-time collaboration among remote or distributed teams.

Qualio delivers on all the document management benefits outlined above. Additionally, our software comes equipped with built-in processes and safeguards to ensure FDA/ISO compliance. From certification preparation to audit readiness, our QMS supports all planning, training, monitoring, and management exercises.

Here is a list of the top medical device document management tips.

1. Set a Zero-Tolerance Policy for Undefined Documents

We recommend setting a zero-tolerance policy for undefined documents. All newly created documents should be clearly defined, with an appropriate naming convention and file structure in place. Setting a zero-tolerance policy for undefined documents improves file organization and, as a result, serves an effective risk mitigation strategy.

Start by creating a tag template that incorporates established security, document profile, and audit trail settings. Every file type and tag should be communicated across the organization. 

Additionally, creating a template teams can copy will help ensure that file types and tags are created in conjunction with your organization’s policies.

Paper-Based System to QMS Software

2. Leverage Cloud Storage

When you consider the total volume of documents that medical device startups and scale-ups create and manage, investing in cloud storage is a clear and obvious document management best practice. 

Today, advanced cloud computing platforms have changed the way medical device organizations store important documentation.

Additionally, distributed teams benefit from the collaborative opportunities that cloud computing provides. Thanks to the cloud, important documentation can be accessed from anywhere.

Moreover, cloud storage typically comes with advanced safety and security features. As a result, document management teams never have to worry about documentation falling into the hands of nefarious actors or third parties.

3. Create a Standard Naming Convention

We recommend activating consistent and logical file naming conventions. As a best practice, file names should include the date, document type, status, and any other important details needed to properly categorize the document’s contents.

Here are some other practical tips for establishing clear file naming conventions:

  • Follow a standard date format (e.g., dd-mm-yy).
  • Use a numbering schema to organize large folders or files
  • Create acronyms for common file types (e.g., bd = business documentation).

4. Organize Files by Format

Sometimes, organizing by file names won’t come as easily as file formats. For this reason, it’s a good idea to organize files by format or type instead. 

As a general rule, create templates for document types, including internal audit documentation and change control forms, among other things.

By creating pre-built templates, creating documentation from scratch is a thing of the past. What’s more, templates reduce the chances of employees creating formatting variations from document to document. It also makes it easier to quickly identify document type and, as a result, store and organize the file. 

Paper-Based System to QMS Software

5. Automate with a Quality Management System

You could implement the aforementioned medical device document management tips manually. But if you really want great results, you could opt to automate your document management process with a QMS. 

Unfortunately, manual processes are time-intensive, prone to errors, and may inadvertently expose your medical device organization to major compliance issues.

When it comes to file storage and access, the right QMS will deliver increased efficiency and peace of mind. 

So, how do you move from a paper-based system to a full-featured digital solution like Qualio? To kickstart the process, we recommend downloading our free guide: How to Migrate from a Paper-Based System to QMS Software.

In this guide, you’ll learn how to:

  • Find the right people to lead the transition
  • Establish mission-critical system adoption and onboarding processes
  • Establish system adoption and onboarding deadlines
  • Turn reluctant users into software advocates

Download the guide and take the first step toward document management automation.

Paper-Based System to QMS Software

The easiest, fastest way to transition from paper to QMS software

Learn from the best in quality.  Download your guide now.

Published by Kelly Stanton April 20, 2021