How technology can ensure adherence to regulatory requirements
Two worlds are colliding and it’s very exciting because they promise to give birth to a promising new future. The two worlds are Technology, with blockchain, and Regulatory, with data integrity. Combined the two appear to be the ingredients that, when combined, will solve many problems we face today.
First, let’s talk about blockchain, which is a bunch of blocks linked together. Each block contains data which can be linked to another block, forming a block chain. The link is secured by unique key (cryptography that contains a hash and a pointer). Finally, there’s a distributed ledger that keeps track of everything. Let’s leave it at that for now. What’s important is to know that:
a) blocks of data are immutable and can be relied upon;
b) the data can be tracked back to the source; and,
c) the blocks of data are secure.
Second, we have data integrity. Data integrity is a regulatory hot topic with the ALCOA acronym identifying attributes necessary to ensure integrity:
When we combine blockchain with data integrity, we begin to deliver upon ALCOA attributes.
- ATTRIBUTABLE: with blockchain, you can trace data back to predecessors, all the way to its source.
- LEGIBLE: digital information is more legible and easier to decipher than handwritten data. This applies to all the different types of data that adhere to standards and protocols such as ASCII, JPEG, PDF, XML, etc. True, data can be illegible and garbled, but this can be promptly identified. Furthermore, computer systems can automatically validate data at the point of capture which helps ensure legibility.
- CONTEMPORANEOUS: digital information is more contemporaneous than handwritten because it is captured at point-in-time. True, it can be recorded later, but that’s the reason why data/time stamps are important, along with secure logins to trace back to an individual.
- ORIGINAL: the fact that blockchain will trace back to a source helps ensure originality. Having other parties, or even systems, add to the blockchain, or read the blockchain, and verify against the ledger, validating the link (including pointers, decryption, and hashes), and block data itself, provides an inherent system of checks-and-balances. Bottom line, you can make assurances the data is original with leveraging blockchain technology.
- ACCURATE: out of all the ALCOA attributes, and exploring how blockchain can help deliver, the accurate attribute is the least reliable. But this is not a problem, it’s just something to be aware of and address. There are other ways to ensure data accuracy. For example, blockchain’s Smart Contracts functionality may be a solution to the accuracy challenge. Hereby a smart contract can be logic that is executed by another system to validate the data itself. This is just an example.
If you think this is far-fetched, bleeding-edge technology, think again. IBM Watson Health and Food and Drug Administration (FDA) are already working on it. https://bitcoinmagazine.com/articles/ibm-watson-health-and-fda-to-collaborate-on-blockchain-project-1484148297/
We truly are living in exciting times.
About the Author
|Steve Thompson is Senior Manager of Professional Services and is responsible for managing ValGenesis’s Implementation & Professional Services in the West Coast Region of the United States. Steve has over 20 years of GxP experience in Life Sciences (including Medical Device), is a Parenteral Drug Association (PDA) certified Auditor, has held managerial positions at various levels within Information Technology (IT) and Quality Assurance (QA) for major organizations, is a published author and has presented at several conferences and industry associations. Steve has a B.S. in Computer Information Systems from DeVry University, City of Industry, California.|
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