Faster Science: Why Scientist.Com’s Blockchain Approach is the Answer to the Pharmaceutical Industry’s 21 C.F.R. Part 11 Compliance Challenges

20 Wake Forest J. Bus. & Intell. Prop. L. 132

The pharmaceutical industry makes substantial investments in R&D
to bring innovative health care solutions to market. These solutions help
sick patients recover faster, prolong life expectancy, and bring comfort
to those with destructive illnesses. Yet, the industry faces immense
regulatory challenges. Title 21 CFR 11 (Part 11) establishes the Food
and Drug Administration’s (FDA) regulations for electronic signatures
and record keeping in the pharmaceutical industry. Part 11’s broad
scope has proved burdensome since its inception in 1997 because it
applies to all FDA-mandated regulations, such as manufacturing
practices and development protocols. A Part 11 violation can affect a
company’s goodwill, patent revenue, R&D, and overall bottom line.
Blockchain is an emerging technology that provides an innovative and
robust solution to these regulatory challenges. Although implementing
a blockchain approach may be costly for some newer or smaller players
in the pharmaceutical industry, companies such as Scientist.com make
it straightforward to integrate a ready-made blockchain approach. This
timesaving approach has already helped fifteen of the top twenty-five
pharmaceutical companies, saving the industry time and money. These
reduced transaction costs help get much-needed medications to the
market quicker—truly promoting “faster science.”