SOPs in Microsoft Word – A Weak Link?

Progressive organizations are quickly moving toward electronic systems, especially in clinical operations – for good reason. Electronic TMFs help eliminate the inefficiencies and complications associated with paper trials, but many clinical teams stop short of a full transformation. Instead, they simply layer an electronic system over paper processes. Going a level further and completely eliminating paper can deliver more dramatic benefits across clinical development.

Take the creation and maintenance of Standard Operating Procedures (SOPs), for example. Although many consider this to be an integral part of an eTMF system, simply duplicating a paper process electronically does not take advantage of more advanced capabilities. With an eTMF application, workflow processes are built into the system, challenging common expectations of the form SOPs can take. Standalone, Microsoft Word based documents that reside outside your electronic solution represent a throwback to paper-based thinking. Relying on these documents to guide studies introduces real compliance risks – dangers sophisticated electronic systems are designed to prevent.

Maintaining your SOPs electronically helps enforce compliance. If your organization is using an eTMF, chances are you spent a considerable amount of effort configuring (and hopefully not programming) your operating procedures right into the system. You probably defined business roles, permissions for each role, dependencies on what one role does versus another, etc. Then, elsewhere in the system, you defined which people in your company filled each role. Only those individuals with the appropriate business role can complete certain tasks, and the order of task execution can be controlled such that nobody can act out of turn.

Inside this system, you have specified all the content that you would otherwise add to an SOP document you were authoring in Microsoft Word. Even better, the system may already include a diagram depicting your configured workflow, something you might otherwise sketch out in a program like PowerPoint or Visio. Imagine if instead of writing your SOP in Word, you clicked a button in the system and it generated a PDF or Word document in a basic (or even template-based) format – wouldn’t you have almost everything that you write from scratch today?

As most of these systems support GxP, change control for your system configuration is in effect. The eTMF provides you an audit trail of when a particular process was modified, why the process was changed, and who approved it. Not only can the SOPs be generated from the system, but the change control records for those SOPs could too!

I have watched our customers configure process workflows in Vault eTMF just by interpreting their SOP documents. As a product manager I love to see mission-critical policies and procedures come to life in Vault. As more and more organizations embrace paperless solutions, I’m proud to see Veeva playing a role in moving the industry forward.

Todd Tullis is senior product manager, Vault eTMF at Veeva.