eReg checklist

eRegulatory Buyer’s Guide: A 38-Point Checklist

Joe Wochna eRegulatory, Regulatory Compliance

eReg checklistAs a research coordinator or administrator, being buried under a mountain of paper files is not something that has to happen often before it becomes apparent there must be a better way. That better way is an eRegulatory system.

In response, some research sites will develop a homegrown solution, often using shared drives. This is not the best choice if the objective is to deliver real value, increase efficiency, and ensure compliance. The most appropriate option is a professionally designed solution, developed by experts in both regulatory responsibilities and information technology.

The good news is the number of technology providers offering eRegulatory systems has increased. The bad news is this influx of providers can complicate the selection of the solution that is right for your organization.

There are many aspects to consider. Does the system meet 21 CFR Part 11 requirements? Does it provide the necessary security and access controls? Does it support eSignatures? Will the system scale to meet future needs? Without answers to those and many other questions, selecting the right system for your site can be daunting and little more than a roll of the dice.

Choosing an eRegulatory solution isn’t about finding the one with the most features or offerings, it’s about finding the solution that is most applicable to your institution’s current and future needs, and the vendor that will partner with you to ensure your needs are met along the way.

Complion, an expert in eRegulatory document management, has an eRegulatory Buyer’s Guide available that will help you make an informed decision for your organization. The resource provides a detailed breakdown of the critical considerations for selecting a system, offering an at-a-glance perspective on functionality, visibility, scalability, ease of use, and many other considerations.

Make sure the eRegulatory solution you select for your organization is the best choice for delivering value, increasing efficiency, and ensuring compliance. Download Complion’s eRegulatory Buyer’s Guide.