Working in a Regulated Environment

It’s different in a number of ways, depending on who is regulating you.

For example, you may be lightly regulated, as the rail equipment company I worked for was. By this, I mean that you have to track things like the big edit reviews and resulting comments and all previously released product documentation. Design specs after a certain point had to be auditable, as did factory floor policies and procedures. As did training materials used to teach people how to use the products.

Fundamentally, anything that was required to show auditors how the product and the product instructions got be the the thing out in the field has to be tracked. And, because this equipment was very robust, they had to track it essentially forever, as the products worked in the field for at least 50 years.

If a railroad crossing failed and people or property were damaged, the company had to be able to show the documents that shipped with the products, how that information came to be in the manuals, how the equipment was made, and how the end users were trained to use the equipment. For as long as that equipment was functioning in the field.

They had a lot of paper in a lot of file cabinets.

What they all have in common

Regardless of the industry – FDA, Financial, SOX, Solvency II, other government – it comes down to audit trails. You have to be able to show the trail of content that got you to the place you are right now. And that means history of content development in some manner.

If you’re using Word or InDesign, you have to depend on an external document management system and somehow track when and how the changes came to be.You must track versions of what shipped and when to who and why. You have to track review comments.

You wind up with a lot of paper in a lot of filing cabinets.

There are better ways

There is another way – you can track and manage the components in your content. Using the right component content management tool, you can use the history features to show you this information. You can also manage your review comments electronically. It’s a lot easier than trying to manage all these parts on your own.

To see how Author-it manages history and audit trails, watch the movie below.

 

Have you worked in a regulated environment? What were the restrictions you faced?

By Sharon Burton