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eForms Learning from Bitcoin's Blockchain in Pharma & Biotech Part 2/2

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Pharma and Biotech - What can we learn from Bitcoin and the Bitcoin Technologies

In Part 1, available here, I introduced the idea of using the technology used by Bitcoin and other cryptocurrencies for the pharmaceutical and biotech industries. In the first part, I talked about two of the four key aspects, Decentralization and Trust. Lets wrap up the discussion with Blockchain and Private and Public Keys.

3 - The Blockchain

I would argue that the main feature of Bitcoin that corporations and the media focus on is the ‘Blockchain.’ The Blockchain in its simplest definition is a database containing a list of chronologically ordered transactions all linked by a cryptographic hash that is immutable and permanent - a list of data that cannot be changed. If the data does get changed, then the ‘chain’ would break, and we would have a data integrity issue.

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A Blockchain created and ‘linked’ over time

A detailed explanation of hashes will be the subject of a future article, but for this essay, we will assume it is a mathematical function that will generate a large unique number that contains information from both the current and previous transaction. Each transaction added to the Blockchain will have the data contained in its transaction (i.e., say a logbook entry into an equipment tracking database table) ‘hashed’ together with the previous transaction’s hash and then it is stored in the database. Blocks and transactions are ‘chained’ together through this cryptographic hash. Now envision record after record, transaction after transaction, linked together forever in the Blockchain. This is a ‘very’ simple description of what takes place. Bitcoin bundles transactions into 1 Megabyte blocks and then links those 1 Meg blocks together. But you get the idea.

At first, it is a little overwhelming to consider what is going on, but as I started to realize what was happening during this part of the Bitcoin design, my thoughts jumped to how this type of cryptographic hash would be beneficial to corporate data on ‘private’ company Blockchains. Remember, the Bitcoin Blockchain is on the internet all over the world. There is no reason to think that we cannot have corporate Blockchains that benefit a company as much as the Bitcoin Blockchain serves all users and holders of the Bitcoin currency.

4 - Private and Public Keys

The last item we need to talk about is the use of ‘private’ keys to ensure the ownership of Bitcoins. Users of the Bitcoin system use a ‘Wallet’ to send and receive Bitcoins. A Wallet is a software application that contains a ‘private’ key that only the owner of the wallet knows. This key is much like the password we all use today, but extremely more difficult to guess or break because it is a number so large you would need a quantum computer to figure it out with a few years of processing time. With this private key, the owner of a wallet can generate ‘public’ keys that other users of the network can send Bitcoins to. These public keys are what Bitcoins are assigned to on the Blockchain when users engage in the sending and receiving of the currency.

Let’s rehash (no pun intended) on what we know about the Bitcoin system at this point:

  1. Bitcoin is a decentralized network of machines that exist on the Internet. All Bitcoin servers contain the same core software. There is no master node - hence decentralized. All the nodes working together act as a large 'Virtual Machine.'
  2. Bitcoin has ‘trust’ built into the system with no third-party present to authenticate that trust. The trust on the network is established by ‘miners’ validating transactions and by keeping each other honest and ensuring transactions are valid and guarantees that any given Bitcoin cannot be ‘double spent.’
  3. The database of the Bitcoin system is the ‘Blockchain.’ This database of Bitcoin transactions is immutable and cannot change. This database contains the activity of every Bitcoin ever created since the beginning of time (2009 in Bitcoins case).
  4. Bitcoins are received and spent by user Wallets that contain the user’s private keys, and through the use of public keys generated from the private key, the Bitcoin users can send and receive Bitcoins with confidence since only they know their private keys.

We now have a high-level overview of how the Bitcoin system works. Let’s make the jump to see how we can use these features in Pharma and Biotech. We’ll revisit the first list in this essay, and apply a Bitcoin feature to support it.

  • Data Integrity - The Blockchain - using client software within our companies and corporations to write critical data to a companywide encrypted ledger - a CompanyChain if you will. We can use encryption to protect sensitive data even further.
  • Data protection - The ‘Virtual Machine’ aspect of Bitcoin gives us multiple copies of the data everywhere a core node is operating. We can structure our private and public cloud nodes to have copies of the Blockchain database. The use of open source software and hardware is critical here in helping us control the cost of these networks coming online. This has traditionally been a big sticking point of corporate IT cultures.
  • Transaction Dates - The Blockchain gives a ‘write-once’ / ‘read-many’ database that does not allow for information to be re-written. All data is actually a new record. The ability to capture dates of both valid transactions and transactions that need to be modified and dated again all get recorded. Nothing is ever lost when tracing all the actions on a particular manufacturing lot or piece of equipment.
  • Auditable Records - The Blockchain can be examined at any time. The chain can be ‘walked’ or traced for any manufacturing lot or piece of equipment.
  • Data Retrieval - With multiple nodes present and multiple Blockchain databases available, no one system is taxed by different users of the data within the corporation. The Virtual Machine alleviates the data bottlenecks and resource loading on database servers.
  • Data Availability - The Bitcoin network with all the nodes running the same software and maintaining the exact data on each node is, in fact, a ‘Virtual Machine.’ A machine that exists as a decentralized application that cannot go down. Could you imagine telling your manager or corporate director that you are going to install an app within your corporation that will never go down? Having a mix of corporate side and cloud-based open source servers that support your main company Blockchain. Open source software is a new concept for most corporate IT divisions. Non-Unix servers are the predominant machines in corporate IT establishments, and this could add a significant cost if you scale to multiple nodes to give your virtual machine more robustness. This is a business decision that must be considered.
  • Electronic Records - 21 CFR Part 11 - Private Keys - each employee or person acting in the interest of the company is assigned a private key and then can sign activities that get recorded on the Blockchain.

I think you’ll agree that is almost scary how much of this makes sense to consider. One hundred percent uptime and Blockchain transactions with complete traceability! Wow!

The Bitcoin Architecture gives us a few things to think about as we consider the future of software within the corporations we work for and do business. Corporations will be looking to become more ‘autonomous,’ requiring less reliance on the human capital while at the same time increasing its dependency on the ‘machine.’ As IT professionals, it is our job to help the companies we work for to become more efficient and productive. With productivity stalled in western countries, we need to look at these technologies and see how they can help us all move forward.

The Internet gave us a network that is available all the time. Bitcoin provides us with a machine and a database that is available all the time. Let’s see if we can leverage these technologies into making our companies run paperless and more efficiently. DSI is committed to the concept and is integrating Blockchain into eForms, our paper on glass electronic process logbook, forms, and work instructions system. 

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