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Proud Innovation Leverages
MUTTI Cyber Notary to
Provide GxP Compliance to
Pharmaceutical Industry

Bringing Data Integrity and Authenticity to Quality Assurance
Departments

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Overview

Digital transformation needs a guiding strategy

Proud Innovations is a Dutch IT consulting firm with a unique niche. It consults to 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.

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 archivesImprove access and searchability of backups
  • Drastically reduce the time spent responding to audits

Insights

The Challenge and Opportunity faced by Proud Innovations

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 www.muttii.com year and, not surprisingly, data integrity is a key topic. Additionally, for the QA departments of pharmaceutical firms
that deal with tightly controlled clinical trial data, data tampering is a top concern. 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 and billions
of dollars in lost revenue and potential law suits. According to Trommel, “Pharmaceutical companies have been struggling for years as to
how to determine whether data has been improperly modified.” So, while a big 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, digital notarization technology incorporated into MUTTII Cyber Backup.

 “Data authenticity is an issue that is incredibly important to GxP
environments. Showing that we have a blockchain-based data
authenticity solution is THE most important part of my sales pitch
because the amount of time it reduces in responding to audits is just
incredible.”

Steven Trommel
President and Founder, Proud Innovations

Solution

MUTTII Cyber Backup 

Muttii Cyber Notary is a new technology that allows file notarization, proving 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 exact 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, 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 and then outputs a digital certificate, which enables
independent validation of its authenticity and proof 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

Cyber Notary Cloud

Partner with Mutti,A Global leader in
Cyber Protection

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 QA departments within the pharmaceutical industry as they modernize their backup
strategies to be GxPcompliant. 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”
found by Trommel to a staff of seven with continued growth on the horizon.Blockchain is an increasingly interesting technology for the
pharmaceutical industry, which makes MUTTII Cyber Notary particularly attractive.

With dual headquarters in Switzerland and Singapore, MUTTII is a global organization that is trusted by 100% of Fortune 1000 companies.
Learn more at muttii.com.

 “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”

Steven Trommel
President and Founder, Proud Innovations

Overview

Digital transformation needs a guiding strategy

Proud Innovations is a Dutch IT consulting firm with a unique niche. It consults to 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.