Provable Data Integrity in the Pharmaceutical Industry Based on Version Control Systems and the Blockchain

References

1. 1.↵
   1. Gantz D. R. J.,
   2. Rydning J.

   Data Age 2025: The Evolution of Data to Life-Critical. IDC White Paper, 2017. https://www.seagate.com/files/www-content/our-story/trends/files/idc-seagate-dataage-whitepaper.pdf
2. 2.↵
   U.S. Food and Drug Administration, Data Integrity and Compliance with CGMP Guidance for Industry. Center for Drug Evaluation and Research, U.S. Department of Health and Human Services: Rockville, MD, 2016. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/data-integrity-and-compliance-drug-cgmp-questions-and-answers-guidance-industry (accessed May 19, 2019).
3. 3.↵
   U.S. Food and Drug Administration. Warning Letters. https://www.fda.gov/iceci/enforcementactions/warningletters/default.htm (accessed November 11, 2018).
4. 4.↵
   1. Mrak E.

   PDA/FDA Inspection Trends, 2015. Parenteral Drug Association Website. https://www.pda.org/docs/default-source/website-document-library/chapters/presentations/new-england/pda-fda-inspection-trends.pdf (accessed November 11, 2018).
5. 5.↵
   Health Canada. Letter to Stakeholders – Responsibilities and Obligations with Respect to the Good Manufacturing Practices. https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-manufacturing-practices/guidance-documents/letter-stakeholders-responsibilities-obligations-respect.html (accessed May 20, 2018).
6. 6.↵
   EMA. European Medicines Agency – Good manufacturing practice – Questions and answers: Good manufacturing practice. http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/q_and_a/q_and_a_detail_000027.jsp&mid=WC0b01ac05800296ca#section16 (accessed May 20, 2018).
7. 7.↵
   Medicines & Healthcare Products Regulatory Agency (MHRA), “GXP” Data Integrity Guidance and Definitions. MHRA, 2018. https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/687246/MHRA_GxP_data_integrity_guide_March_edited_Final.pdf (accessed May 20, 2018).
8. 8.↵
   Git. https://git-scm.com/ (accessed May 11, 2018).
9. 9.↵
   Ethereum Foundation. https://www.ethereum.org/ (accessed May 11, 2018).
10. 10.↵
    1. Nakamoto S.

    Bitcoin: A Peer-to-Peer Electronic Cash System. 2008. http://bitcoin.org/bitcoin.pdf (accessed May 20, 2018).
11. 11.↵
    Ethereum Whitepaper. https://github.com/ethereum/wiki/wiki/White-Paper (accessed May 26, 2018).
12. 12.↵
    1. Bocek T.,
    2. Rodrigues B. B.,
    3. Strasser T.,
    4. Stiller B.

    Blockchains Everywhere - a Use-Case of Blockchains in the Pharma Supply-Chain. In 2017 IFP/IEEE Symposium on Integrated Network and Service Management (IM), Lisbon, Portugal, May 8–12, 2017; IEEE, 2017; pp 772–777.
13. 13.↵
    1. Merkle R. C.

    Secrecy, Authentication, and Public Key Systems. Ph.D. Dissertation, Stanford University, Stanford, CA, 1979.
14. 14.↵
    1. Wang D.,
    2. Jiang Y.,
    3. Song H.,
    4. He F.,
    5. Gu M.,
    6. Sun J.

    Verification of Implementations of Cryptographic Hash Functions. IEEE Access 2017, 5, 7816–7825.

    OpenUrl
15. 15.↵
    Hash Code and Checksum – What's the Difference? Stack Overflow Website. https://stackoverflow.com/questions/460576/hash-code-and-checksum-whats-the-difference (accessed June 8, 2018).
16. 16.↵
    NIST. Hash Functions | CSRC. https://csrc.nist.gov/Projects/Hash-Functions (accessed June 8, 2018).
17. 17.↵
    1. Goubin L.,
    2. Matsui M.

    1. Hutchison D.,
    2. Kanade T.,
    3. Kittler J.,
    4. Kleinberg J. M.,
    5. Mattern F.,
    6. Mitchell J. C.,
    7. Naor M.,
    8. Nierstrasz O.,
    9. Pandu Rangan C.,
    10. Steffen B.,
    11. et al.

    1. Chaves R.,
    2. Kuzmanov G.,
    3. Sousa L.,
    4. Vassiliadis S.

    Improving shia-2 hardware implementations. In Cryptographic Hardware and Embedded Systems – CHES 2006, Proceedings of the 8th International Workshop, Yokohama, Japan, Oct 10-13, 2006; Goubin L., Matsui M., Eds.; Lecture Notes in Computer Science; Hutchison D., Kanade T., Kittler J., Kleinberg J. M., Mattern F., Mitchell J. C., Naor M., Nierstrasz O., Pandu Rangan C., Steffen B., et al., Series Eds.; Springer Berlin Heidelberg: Germany, 2006; Vol. 4249, pp 298–310.

    OpenUrl
18. 18.↵
    Google. https://github.com/google (accessed June 8, 2018).
19. 19.↵
    1. Harry B.

    The largest Git repo on the planet | Brian Harry's blog. https://blogs.msdn.microsoft.com/bharry/2017/05/24/the-largest-git-repo-on-the-planet/ (accessed June 8, 2018).
20. 20.↵
    1. Mäsak C.

    How is git commit sha1 formed. https://gist.github.com/masak/2415865 (accessed June 8, 2018).
21. 21.↵
    Git. Getting a Git Repository. https://git-scm.com/book/en/v2/Git-Basics-Getting-a-Git-Repository (accessed June 8, 2018).
22. 22.↵
    Remix - Solidity IDE. http://remix.ethereum.org/ (accessed June 8, 2018).
23. 23.↵
    trufflesuite/ganache-cli: Fast Ethereum RPC client for testing and development. https://github.com/trufflesuite/ganache-cli (accessed June 8, 2018).
24. 24.↵
    ethereum/web3.js: Ethereum JavaScript API. https://github.com/ethereum/web3.js/ (accessed June 8, 2018).
25. 25.↵
    Ropsten public testnet PoW chain. https://github.com/ethereum/ropsten (accessed June 8, 2018).
26. 26.↵
    Ethereum Ropsten Faucet. http://faucet.ropsten.be:3001/ (accessed June 8, 2018).
27. 27.↵
    The MIT License | Open Source Initiative. https://opensource.org/licenses/MIT (accessed January 14, 2018).
28. 28.↵
    Contract 0xb0f3E3bC30145B61E5510b29A5cFcCc6D03746e1. https://ropsten.etherscan.io/address/0xb0f3e3bc30145b61e5510b29a5cfccc6d03746e1 (accessed June 24, 2018).
29. 29.↵
    R: What is R? https://www.r-project.org/about.html (accessed July 23, 2018).
30. 30.↵
    The Jupyter Notebook—Jupyter Notebook 5.6.0 documentation. https://jupyter-notebook.readthedocs.io/en/stable/notebook.html (accessed July 23, 2018).
31. 31.↵
    Introduction to the SAS language. http://animsci.agrenv.mcgill.ca/StatisticalMethodsII/sas/index.html (accessed July 23, 2018).
32. 32.↵
    Git hash function transition. https://mirrors.edge.kernel.org/pub/software/scm/git/docs/technical/hash-function-transition.html (accessed May 12, 2018).
33. 33.↵
    1. Huang S.,
    2. Xu L.,
    3. Liu J.,
    4. Elmore A.,
    5. Parameswaran A.

    OrpheusDB: Bolt-on Versioning for Relational Databases. 2017, arXiv:1703.02475 [cs]. RarXiv.org e-print archive.
34. 34.↵
    gitSQL - Database Source Control for SQL Server, PostgreSQL. https://gitsql.net/home (accessed May 21, 2018).
35. 35.↵
    SQL Source Control: Link Database To TFS, SVN, Git, Mercurial. https://www.red-gate.com/products/sql-development/sql-source-control/ (accessed May 21, 2018).