Do the WORM to Protect Your Most Valuable Assets


Consider your business’ myriad of assets – bank accounts, property, intellectual capital, processes, etc. Which of them qualifies both as a highly valuable asset and a significant liability? It is your data. That information is the source data you collect from each subject visit. The forms, documents, and communications, all of which must be saved to fulfill your regulatory obligations, are what Sponsors and regulators require of you. How do you protect your most valuable assets, minimize the risk of loss or corruption, and at the same time maximize its value to your organization? The right software is the answer.

There’s an old saying that applies here: “You don’t have to run faster than the bear to getaway. You just have to run faster than the guys next to you.” *

This quote accurately describes the current cybersecurity landscape. There are lots of fast and hungry bears out there. The good news is you do not need to outrun the bears. You only have to be slightly faster than the next person. The better news is even if the cyber bear gets you, you can still protect your data.

We at take your data integrity and security very seriously. Our approach goes well beyond what is required by CFR 21 Part 11 and ICH E6(R3). One way we protect your data is by employing a technique called WORM: Write Once, Read Many. Once a document is written in our system, it can never be modified. If you want to alter that document, we will create a new version of it, which means cyber criminals can never overwrite documents. For example, when a document is modified, e.g., electronically signed, our platform automatically makes a copy and signs that copy, thereby leaving the original document unchanged. This means the original version of the document can never be lost – either accidentally or due to a ransomware attack.

Since your data is in electronic format, you may take advantage of the multitude of features, such as automatic document tracking, searching, reporting, electronic signatures, remote monitoring, etc., which come standard with our platform. These features will help you be more productive, automate your workflows, reduce errors, and maximize the value of your data.

We are continually evolving our cybersecurity strategies, reviewing the latest research, and thinking about how to “run faster.” We concede that we will never be faster than the bears, but the good news is we do not need to be faster than the bears to keep your most valuable asset safe.


* Author: Jim Butcher