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[Trigger warning: audits

If you’re responsible for compliance, audit can be a scary term across a bunch of industries. This is especially true when your systems of ensuring compliance and legal accountability aren’t as effective as they should be. 

Here’s a sobering fact I pulled from a medical device industry survey

3 out of 4 medical device professionals reported that they weren’t confident they’d pass an unannounced audit by the FDA or Notified Bodies. 

That is… alarming. Especially in an industry that builds devices that directly impact human lives. 

Audits serve as a way of keeping industries honest, making sure their procedures, documentation, and end products are in compliance with any regulatory requirements.

Audits are necessary, but they can be a pain. The easiest solution to achieve compliance is what we aim for, so doing everything we can to make that process less painful is the goal. 

The 75% of medical device professionals not confident in passing an unannounced audit proves the need to bolster workflows and inject accountability that will inspire more confidence. We’re not talking about medical device organizations blatantly being out of compliance, we’re talking about something that’s not malicious, but still very dangerous: bad workflows.

We’ve got what you need to get your workflows on the right track to assuage audit anxiety.

What a Good Workflow Looks Like

Workflows will look different per company, but we’ll take an example from the medical device industry.

A common content deliverable for medical devices is Instructions For Use (IFUs). Simply put, IFUs tell users — in great detail — how a medical device works. Documenting the IFU for medical devices needs to have a workflow that ensures each step in authoring, review, and delivery has certain parties holding it accountable. 

Let’s say your organization makes a medical device that dispenses pharmaceuticals. Let’s look at an example workflow from beginning to end for updating IFUs for that device. 

  • Content Request: It all starts somewhere. When changes to a device are made, its IFU needs updating. This content request comes in and is forwarded to the authoring team. 
  • Authoring: Depending on the device, this team may consist of any number of contributors: writers, editors, engineers, SMEs, etc. This step would make up the bulk of writing the IFUs.
  • Editorial Review: Moving through the workflow, the editorial team reviews the grammar, usage, etc. in the documentation. They ensure that tone, word use, and brand consistency remain throughout the IFU. 
  • SME & Technical Review: Because these devices are complex and perform specific tasks, they will have specifications and scientific jargon particular to certain fields of expertise. 
  • Legal Review: In a highly regulated industry, the second to last review is often the legal team making sure that any standards and laws are adhered to.  
  • eSignature: eSignature is the stamp that says your IFU has gone through each stage of this workflow and is complete, ready to be deployed. The eSignature vouches for the validity and rigor of the workflow while also being its endpoint. 

A good workflow has multiple points of scrutiny from authoring to deploying. A complex medical device shouldn’t be documented by one person, let alone one department. The dependability of your documentation workflows speaks to the dependability of your organization. Audit anxiety can be a thing of the past when everyone is on the same page in a workflow that shows a well-conceived path to compliance. 

Perfecting your workflow requires something extra to give an official authoritative stamp of approval.

The eSignature Signals Authority

An eSignature is the authoritative checkpoint in your workflows. 

In many cases, it’s not just enough to run a great workflow, you need to be able to prove it was done beyond a doubt, the best way to do this is to add eSignature to the process. eSignature has two important impacts: it creates an immutable record for the future and adds weight to someone’s approval, encouraging them to take their review responsibility seriously. In easyDITA, you have eSignature added at any step in the workflow to increase authority or where required by regulations

Let’s clear the air: eSignature isn’t the solution, it’s an integral part of the solution. The solution is really establishing workflows that act as your own internal system of checks and records to accompany your documentation authoring and review processes. 

The eSignature is the proof auditors want to see. By and large, they’re not interested in the, well, flow of your workflow, they care about the physical evidence of the content being approved.

The workflows are totally customizable to fit the chain of command, review, or accountability that’s unique to your organization. Need to change it down the road? No problem. The ability to command the creation of bespoke workflows that establish company-specific audit trails will give you greater confidence in staying compliant. That way, when an audit inevitably comes, your former concern will turn to confidence.

Ready to see how it works? We figured as much: [VIDEO] How to Use the eSignature Feature in easyDITA

Tim Ludwig
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