Blockchain technology & Computer System Validation – what is the impact?
Blockchain technology was introduced over a decade ago, and now it is not only used for cryptocurrency platforms, but it has also evolved into something more significant with the ability to change the rules on how entire supply chains operate. Blockchain is transforming many of the world’s most fundamental business processes. It’s opening the door to new styles of digital interactions that reduce the cost and complexity of getting things done. To address current unforeseen challenges and be better prepared for future ones, businesses will have to transform by implementing more innovative and potentially effective approaches. In this context, trusted, timely and precise information under privacy controls will prove paramount.
What exactly is blockchain?
Blockchain is open-source software where digital units (of money or data) are organized into a series of chronologically grouped transactions, or blocks, which are digitally signed. The technology behind the solution is cryptography (consensus methods, digital signatures, encryption, hash values), coding, and networking technologies, which are managed by sophisticated mathematical algorithms. In other words, a blockchain is a special type of database that stores collected data in blocks which are then chained together. When a new block of data is created, it is linked – or “chained” – onto the previous block. This also means that the data is stored chronologically.
Additionally, the data entered into the blocks forms a shared ledger which is owned and stored by all computers forming a network. This ledger is then constantly compared among the network resources and in case of discrepancies – e.g. manipulation of data from one of the blockchain users/owners – it will always correct itself in order to match the truth, which is verified from the rest of the nodes. Thus, the data cannot be changed, which makes the solution irrevocable.
The solution can come in different configurations, ranging from public, open-source systems to private ones that require explicit permissions to read or write.
Additionally, the data entered into the blocks forms a shared ledger which is owned and stored by all computers forming a network. This ledger is then constantly compared among the network resources and in case of discrepancies – e.g. manipulation of data from one of the blockchain users/owners – it will always correct itself in order to match the truth, which is verified from the rest of the nodes. Thus, the data cannot be changed, which makes the solution irrevocable.
The solution can come in different configurations, ranging from public, open-source systems to private ones that require explicit permissions to read or write.
Blockchain technology has several significant advantages
Security - Assure data integrity across multiple parties
Data added to the chain cannot be changed. All the financial operations are encrypted and linked to the previous block. This makes it easy to trace back the operations and eliminates attempts of fraud.
Transparency - Assure data accessibility across multiple parties
The database operations ledger is always accessible for viewing, making the systems that run on blockchain technology transparent. There is no need to request evaluation or verification of the information from third parties.
Traceability - Locate products instantly
It makes it easier to trace where goods come from.
Automation - Automate processes for increased efficiency and speed
Operations can be automated by “smart contracts” that reduce human interventions and reliance on third parties to verify whether all the participants follow the contract terms. From resolving disputes to triggering next steps in supply chain transactions, to moving medical images through review, “smart contracts” bring efficiency and speed by taking action when established conditions are met.
Considerations for blockchain Implementation
There are several things that enterprises should consider before they start the implementation process.
Analyze opportunities
Investigate the existing options of the technology implementation, including other fields like banking or insurance. You should know how effective the current use cases are and choose the most suitable one for your company.
Evaluate resources
The development and implementation processes are not easy ones. They require professional knowledge and experience. The main requirements to the vendors should be reliability, availability of the resources, previous experience in the solution and the industry.
Identify the areas of enhancement
Know which part of the organization needs improvement. This stage requires analyzing your needs and organizing them for the technology. Identify your own use case, and it will help you clarify the goals you want to achieve and then build the next steps around it.
Develop Proof of Concept
It is essential to determine whether it is feasible and functional to execute the task at this stage. Proof of Concept will guide you through the rest stages of the implementation process, as it is a sketch or outline of how the solution can be successfully implemented in your organization’s environment.
Choose the right platform
Nowadays, there are several networks where you can start adopting the technology, including Ethereum, Corda, Hyperledger, etc.
Build and Test the Solution
It is crucial to properly validate that the solution is working as expected and thoroughly test it. A robust risk-based Computer System Validation based on the industry accepted GAMP5, with properly documented and executed IQ/OQ and UAT must be the minimum requirement for testing.
Deployment
Final step will be to deploy the solution.
Challenges, Security and blockchain best practices
In principle, a blockchain-enabled solution would be no different than a solution employing a traditional database. When we are dealing with GxP data in traditional databases, we need to consider building and validating them to ensure data integrity according to the regulatory requirements. Thus, similar measures need to be considered for a blockchain enabled application.
In addition to the above, we need to consider entirely new ways of approaching the build and validation effort due to the very nature of the applications and all the new system architectures created with blockchain as the main component.
In addition to the above, we need to consider entirely new ways of approaching the build and validation effort due to the very nature of the applications and all the new system architectures created with blockchain as the main component.
Blockchain Enterprise Security
When developing an enterprise blockchain application, it's critical to think about security at all layers of the technology stack, as well as how to manage the network's governance and permissions.
Traditional security controls as well as technology-specific controls are part of a complete security plan for an enterprise blockchain solution.
The following are some of the security controls unique to enterprise blockchain solutions:
• Identity and Access management
• Security Key management
• Data privacy
• Secure communications
• Smart Contract security
• Transaction endorsement
Traditional security controls as well as technology-specific controls are part of a complete security plan for an enterprise blockchain solution.
The following are some of the security controls unique to enterprise blockchain solutions:
• Identity and Access management
• Security Key management
• Data privacy
• Secure communications
• Smart Contract security
• Transaction endorsement
Tips and best practices
When designing or validating a blockchain solution, the following aspects need to be taken into consideration:
• Governance model of participating organizations and/or members
• Data to be captured in each block
• Relevant regulatory requirements and how they are being met
• Management of identity details, encryption of block payloads, security keys management and revoking
• Disaster Recovery plan for blockchain participants
• Minimal security requirements of blockchain participants
• Blockchain block collisions logic and resolution
When developing and qualifying a private blockchain, be sure it's running on a secure, reliable infrastructure. Poor underlying technology choices for company goals and operations can lead to data security problems through their vulnerabilities.
Consider the risks to your business and governance. Financial consequences, reputational concerns, and compliance risks are all examples of such business risks. The decentralized nature of blockchain technology creates governance issues, which necessitate tight controls on decision criteria, governing policies, and identity and access management.
Understanding and managing blockchain network risks is important to blockchain security. A blockchain security model is the plan to add security to these controls. Create a blockchain security model to ensure that all of the necessary safeguards are in place to keep your blockchain solutions safe.
• Governance model of participating organizations and/or members
• Data to be captured in each block
• Relevant regulatory requirements and how they are being met
• Management of identity details, encryption of block payloads, security keys management and revoking
• Disaster Recovery plan for blockchain participants
• Minimal security requirements of blockchain participants
• Blockchain block collisions logic and resolution
When developing and qualifying a private blockchain, be sure it's running on a secure, reliable infrastructure. Poor underlying technology choices for company goals and operations can lead to data security problems through their vulnerabilities.
Consider the risks to your business and governance. Financial consequences, reputational concerns, and compliance risks are all examples of such business risks. The decentralized nature of blockchain technology creates governance issues, which necessitate tight controls on decision criteria, governing policies, and identity and access management.
Understanding and managing blockchain network risks is important to blockchain security. A blockchain security model is the plan to add security to these controls. Create a blockchain security model to ensure that all of the necessary safeguards are in place to keep your blockchain solutions safe.
Final thoughts
The use of blockchain technology has just recently begun to gain momentum, and there is still a lot to learn. A well-developed platform can alter how organizations interact and collaborate with one another, as well as how they deliver services to clients.
Here at i2b we employ a diverse team of consultants who can assist you in every step of the way – from initial inception and requirements definition to validation, testing and deployment of the solution for your organization. Reach out to us for a full assessment of your requirements and a full risk-based estimation of the impact to your business operations!
Here at i2b we employ a diverse team of consultants who can assist you in every step of the way – from initial inception and requirements definition to validation, testing and deployment of the solution for your organization. Reach out to us for a full assessment of your requirements and a full risk-based estimation of the impact to your business operations!
i(nsight)2b
i(nsight)2b will bring you insights and news about implementation strategies, CSV methodologies and interesting insights around new technologies, platfroms and more. Here we will share our latest insights from within the Pharma, Biotech, and IT industries.
Rethink-TMRW_Insight
Rethink: TMRW
An annual summit about the future of track and trace solutions and holistic digital supply chains. Powered by our partner Movilitas we support this conference 10-11 Oct 2022 in Frankfur...
Read MoreGxP and Scrum Insight
GxP and Scrum in the Pharmaceutical Industry
In the pharmaceutical industry, which is highly regulated, strict rules apply in all its sectors, including the computer system projects. Such rules are ...
Read MoreComputer System Validation and Climate Change
Recently, many businesses have made serious commitments to address their own actions to contribute to climate change. Focusing on sustainability in business models and corporate governance can give bu...
Read MoreValidation for the Cloud Insight
The pharmaceutical sector's information technology requirements are following industry trends, forcing a transition to cloud computing. But how does this affect your validation efforts? Click here to
...
Read MoreThe Pharma Industry is turning to blockchain technology – are you prepared?
We covered the recent emergence of Blockchain technology as well as the challenges it presents to the validation activities, but can this technology transform a more “traditional” organization like a ...
Read Moreinterviewing2b: Regular V Model Computer System Validation, is this still feasible?
Computer system validation has been getting increasingly complex and with a growing number of details required, while often the validation effort overshoots the implementation or development work spen...
Read MoreBlockchain technology & Computer System Validation – what is the impact?
Blockchain technology was introduced over a decade ago, and now it is not only used for cryptocurrency platforms, but it has also evolved into something more significant with the ability to change the...
Read MorePaperless Computer System Validation (CSV)
In the regulated industries there is the saying “what is not documented is not done”. And in numerous regulated industry organizations, the de facto method of documenting the work being done is almost...
Read More