Success Stories from the Pharmaceutical Industry
Proud Innovation Utilises MUTTI Cyber Notary to Ensure GxP Compliance in Pharmaceutical Industry Case Studies.
Overview
Delivering Data Integrity, Authenticity, and Digital Transformation to Quality Assurance Departments.
Overview
Digital transformation requires a clear and guiding strategy
Proud Innovations is a Dutch IT consulting firm with a specialised niche. It provides consultancy services to pharmaceutical companies on data integrity and assurance, offering guidance on GxP compliance—including Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Documentation Practice (GDP), and Good Clinical Practice (GCP)—while also advising on IT strategies. Leveraging its expertise in digital transformation, Proud Innovations helps clients optimise their operations and enhance data integrity through innovative technologies such as Muttii Cyber Notary.
Key Challenges
Modernise backup and recovery solutions within GxP-compliant environments
Ensure digital transformation and maintain data authenticity
Minimise client burden when responding to more than 60 annual audits
Key Requirements
Deliver a backup and digital data integrity solution that complies with GxP standards
Key Benefits
Transition from paper-based archives
Enhance access to and searchability of backups
Significantly reduce time spent responding to audits
Case Study Insights
The Challenges and Opportunities Facing Proud Innovations
A few years ago, Trommel observed that pharmaceutical QA departments were beginning to bring GxP environments into the digital age. Traditionally, these environments operated as “paper and pencil” systems for managing files and backups. Even departments working with digital files relied on conventional backup methods such as CDs, DVDs, and hard drives. GxP regulations required paper records to be retained for 20 years, resulting in substantial warehousing costs, logistical challenges, and limited access and searchability.
These paper-based records were also vulnerable to natural disasters, highlighting a significant opportunity to modernise these environments with digital data integrity solutions. Leveraging its expertise in IT consulting and digital transformation, Proud Innovations sought to address this gap. However, GxP compliance focuses heavily on auditing and traceability: every issue must be traceable, its root cause identified, and new procedures implemented to prevent recurrence.
Proud Innovations’ clients may face more than 60 audits per year, where data integrity is consistently a critical focus. QA departments are particularly concerned with the risk of data tampering, especially when handling tightly controlled clinical trial data. Scientists are under immense pressure to develop crucial new drugs and secure patents.
Falsifying research outcomes could result in unsafe or ineffective drugs entering the market, leading to potentially billions of dollars in lost revenue and legal liabilities. As Smith notes, “Pharmaceutical companies have been struggling for years to determine whether data has been improperly modified.” While a large market opportunity existed, any technical solution needed to fully address compliance, auditing, data integrity, and authenticity requirements inherent to GxP environments.
Enter MUTTII Cyber Notary—a digital notarisation technology integrated into MUTTII Cyber Backup, providing traceable, secure, and compliant digital records.
Solution
MUTTII Cyber Backup Solution
Muttii Cyber Notary is an innovative technology that enables file notarisation, providing verifiable data authenticity through blockchain. Integrated into MUTTII Cyber Backup, Cyber Notary generates a digital cryptographic hash, or “fingerprint,” unique to each file. This hash is produced by an algorithm that consistently generates the same output for the same input file, allowing verification of the file’s authenticity. Any modification to the input file, however minor, produces a dramatically different fingerprint. The hash algorithm is one-way, meaning it is impossible to derive the original file from the hash alone, making the process tamper-proof.
MUTTII Cyber Notary stores the hash in a public blockchain ledger and produces a digital certificate that independently verifies the file’s authenticity and confirms its existence at a specific date and time. When a file is recovered from an archive, a new certificate can be generated and compared to the original, ensuring a bit-for-bit match. If the hashes do not match, the file has been altered. Each blockchain record is time-stamped, immutable, and independently verifiable, providing a secure and transparent proof of data integrity.
Muttii Cyber Notary Cloud
Partner with Muttii, a global leader in cyber protection.
Advantages
MUTTII Cyber Notary meets all data integrity, digital transformation, and authenticity requirements outlined by the European Commission for the governance of GxP environments.
This has enabled Proud Innovations to assist QA departments within the pharmaceutical industry as they modernise their backup strategies to ensure GxP compliance. According to Trommel, “When our clients create new files, the policy we implement is to immediately back up and notarise the file so we have the original and can determine if it has ever been modified or tampered with.
The benefits of MUTTII Cyber Notary for Proud Innovations are particularly evident in the company’s growth—from Trommel founding a “one-man shop” to a team of seven, with continued expansion on the horizon. Blockchain technology is increasingly significant for the pharmaceutical industry, making MUTTII Cyber Notary especially appealing. The transformative impact of MUTTII Cyber Notary is reflected in Proud Innovations’ rapid growth, highlighting its commitment to innovation and excellence as an IT consulting firm.
With dual headquarters in Switzerland and Singapore, MUTTII is a global organisation trusted by 100% of Fortune 1000 companies. Learn more at muttii.com.
The benefits of MUTTII Cyber Notary to Proud Innovations are most evident in 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. The transformative impact of MUTTII Cyber Notary is evident in Proud Innovations’ exponential growth, underscoring its commitment to innovation and excellence as an IT consulting firm.
With dual headquarters in Switzerland and Singapore, MUTTII is a global organisation that is trusted by 100% of Fortune 1000 companies. Learn more at muttii.com.
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