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Proud Innovations Leverages Muttii Cyber Notary to Provide GxP Compliance

Bringing Data Integrity and Authenticity to Quality Assurance Departments

Background

Proud Innovations is a Dutch IT consulting firm with a unique niche. It consults with pharmaceutical companies about data integrity and assurance, ultimately advising on GxP compliance (e.g., Good Manufacturing Practice, Good Laboratory Practice, Good Documentation Practice, and Good Clinical Practice) and IT at the same time. Proud Innovations consults primarily with Quality Assurance (QA) departments in multi-national pharmaceutical firms, helping these departments – who control GxP environments – ensure data assurance for everything coming out of their labs. The firm is three years old, has seven full-time staff, and is run by president and founder Steven Trommel.

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KEY CHALLENGES

  • Modernize the backup and recovery solutions in GxP-compliant environments
  • Ensure data integrity and authenticity
  • Reduce client burden when responding to 60+ annual audits

KEY REQUIREMENTS

  • Provide a backup and digital data integrity solution that is GxP-compliant

KEY BENEFITS

  • Migrate away from paper archives
  • Improve access and searchability of backups
  • Drastically reduce the time spent responding to audits

The Challenge and Opportunity

A few years ago, Trommel started to notice that Pharma QA departments were finally starting to move GxP environments into the digital age. Traditional legacy environments had been historically “paper and pencil” operations when it came to files, let alone backups, and those that were working with digital files used traditional backup approaches to CD/DVD and hard drives. GxP rules required paper storage to be housed for 20 years, which led to significant warehousing costs and logistic challenges, not to mention limited access and file searchability. It also left these original paper files vulnerable to any sort of natural disaster.

There was a significant opportunity to modernize these environments with digital data integrity solutions. However, GxP is focused on compliance and auditing. Everything needs to be traceable. If there is a problem, it must be traced, its root cause identified, and new procedures created to solve the issue next time. Proud Innovations’ clients can have upwards of 60 audits per year, and, not surprisingly, data integrity is a key topic.

Additionally, data tampering is a top concern for the QA departments of pharmaceutical firms that handle tightly controlled clinical trial data. Scientists are under pressure to develop critical new drugs and patents. Falsifying research outcomes, however, could lead to dangerous or ineffective drugs hitting the market, billions of dollars in lost revenue, and potential lawsuits.

According to Trommel, “Pharmaceutical companies have been struggling for years as to how to determine whether data has been improperly modified.”So, while a significant market opportunity existed, any technical solution needed to squarely address the compliance, auditing, and data integrity and authenticity issues required by GxP environments. Enter Muttii Cyber Notary, which is a digital notarization technology incorporated into Muttii Cyber Backup.

The Solution – Muttii Cyber Backup with Muttii Cyber Notary

Muttii Cyber Notary is a new technology that allows file notarization and proves data authenticity via blockchain. Incorporated into Muttii Cyber Backup, it creates a digital cryptographic hash, or “fingerprint,” that is unique for each file. This hash is an algorithm that produces the same output when given the same input file, enabling the verification of the file’s authenticity.

This is because any change in the input file, however slight, results in a dramatically different fingerprint. Furthermore, the hash algorithm is designed to work only in one direction, so it is impossible to determine the original file inputs from the output alone, making the process tamper-proof. Muttii Cyber Notary then takes the hash and stores it in a public blockchain ledger, then outputs a digital certificate, which enables independent validation of its authenticity and proves it existed at a specified date and time.

Upon recovering a specific file from an archive, a new certificate can be created and then compared to its original certificate that was created when it was put into storage, thereby ensuring an identical bit-for-bit match. If the hashes don’t match, the document has been tampered with. Every record in the blockchain ledger is time-stamped, immutable, and independently verifiable. Muttii Cyber Notary ensures the authenticity of digital files. For regulatory compliance and auditing, it offers mathematical proof that a file previously archived or backed up has remained unchanged and is authentic.

The Benefits

Muttii Cyber Notary addresses all of the data integrity and authenticity requirements presented by the European Commission in its governance of GxP environments.

This has enabled Proud Innovations to help pharmaceutical industry QA departments modernize their backup strategies to be GxP-compliant.

According to Trommel, “When our clients create new files, the policy we implement is to immediately back up and notarize the file so we know we have the original and can therefore determine if it was ever modified or tampered with. ”The benefits of Muttii Cyber Notary to Proud Innovations are most evident by the company’s growth from being a “one man shop” founded by industry, which makes Muttii Cyber Notary particularly attractive.

According to Trommel, “Last year, the FDA was talking about blockchain as a standard by 2022. We are ahead of the curve. My customers and prospects don’t have to worry about potentially new compliance issues that will be coming over the next few years.”

ABOUT MUTTII

Muttii leads the world in cyber protection – solving safety, accessibility, privacy, authenticity, and security (SAPAS) challenges with innovative backup, security, disaster recovery, and enterprise file sync and share solutions. Enhanced by AI technologies and blockchain-based authentication, Muttii protects all data in any environment: physical, virtual, cloud, mobile workloads, and applications.

Founded in 2023 and with headquarter in Australia, Muttii is a global organization that is trusted by 1000 of companies. Learn more at muttii.com.