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Digital Transformation continues to be in focus – but how about culture?

Digital Transformation continues to be in focus – but how about culture?

In a pre-COVID 2019 Survey of global pharmaceutical industry professionals, GlobalData reported that less than half of its respondents had a digital strategy in place and 19% had no plans to implement.[1]

Two of the largest barriers hindering digital transformation in pharma, according to industry professionals, was due to organizational and cultural challenges along with technology integration challenges. This is consistent with McKinsey’s findings from 2016. [2] This situation isn’t exclusive to the pharmaceutical industry. Harvard Business Review reported findings from a 2020 survey across multiple sectors that culture was indeed a contributing barrier to digital transformation.[3]

The pandemic, however, has forced us to take a giant step into a digital and virtual world to perform our day-to-day activities and to ensure business continuity. In fact, in a 2021 survey – GlobalData reported that 35% of pharmaceutical industry professionals believe that digital transformation is accelerated in the pharmaceutical industry by more than five years.[4]

Does this mean that our culture has changed? Ask anyone who has had to virtually perform supplier quality audits of companies with paper-based processes; or those who are frustrated by having to trawl through various sources (paper documents, emails, share points etc.) to find due diligence information. They would likely be the first ones to ask for change and feel that a digital transformation couldn’t come soon enough.

However, according to Harvard Business Review’s study – 46% of the surveyed professionals continue to experience culture as a barrier.[5]  This is not surprising given that it can take several years to change an entire organizational culture. As a part of that cultural change, technology must be integrated across all aspects of the business. 89% of the surveyed professionals believe that a successful implementation depends on having a combination of the right culture, the right processes, and the right technology in place.[6]

Peter Drucker coined the phrase “culture eats strategy for breakfast” – clearly that includes digital strategy. Does your pharma organization have the right culture in place to fully embrace digital transformation?


[1] “Digital Disruption is knocking – is healthcare ready?”, GlobalData Presentation CPhI Worldwide 2019, Bonnie Bain, 2019


[3] “Accelerating Transformation for a Post-Covid-19 World”, Harvard Business Review Analytic Services, 2021


[5] “Accelerating Transformation for a Post-Covid-19 World”, Harvard Business Review Analytic Services, 2021

[6] Ibid;



Bonafi Limited

Suite B119
The LINC Centre
Blanchardstown Road North
Dublin 15, Ireland




BONAFI: Providing Bona Fide Value for your Supply Chain

Welcome to Bonafi

Bonafi is a secure customer and supplier verification system for the pharmaceutical industry. Our system helps wholesalers, distributors, and manufacturers to manage all their customer and supplier verification needs in one place.

The Bonafi application verifies the status of a supplier’s or customer’s authorization to supply or sell medicinal products for human use. Bonafi produces trustworthy records, which fulfills the pharmaceutical industry’s good distribution practice requirements.

Bonafi streamlines your process

Using the Bonafi system streamlines the compliance process. Today, pharma companies must verify each customer and supplier and then re-verify them at least once per year. That manual process is cumbersome, time-consuming, and expensive. By contrast, Bonafi is fast, efficient, economical, traceable and transparent.

Bonafi analyses a client’s verification requests and then searches and cross-references registries to verify the authorisation status for the customer or supplier in question. Supporting data and documentation are also returned and supplied.

In addition, Bonafi offers both fully-automated and semi-automated verification options for its clients. The results we provide are traceable via a complete audit trail.  As a result, Bonafi has improved the verification process and reduced the completion time from months to minutes.

Avoiding Sanctions and Penalties with Bonafi


The compliance requirements for the pharmaceutical industry in the European Union (EU) are complex and expensive to meet. The European Commission also acknowledges that the authorisation requirements increase costs for all involved. Bonafi is automating the process, minimizing those costs, and ensuring compliance and a secure supply chain.

EU pharmaceutical law is rapidly developing. The European Commission is recommending to increase the criminal penalties for falsified medicines to at least three years imprisonment, which would meet the threshold for cross-border investigations.  Also, authorities are increasingly focused on combatting falsified medicines through prosecutions.

Thus, the stakes could get even higher for industry players as new legal risks emerge. But, with Bonafi by your side, it is easy to stay on top of the changing legal and compliance landscape. 

Sanctions & Legal Liability

Sanctions and legal liability are potent weapons in the EU’s regulatory toolbox. While sanctions for non-compliance vary in degree across the EU Member States, there is a general trend towards adopting corporate liability. Bonafi helps its customers follow regulatory requirements so that they can limit their exposure.

Also, for pharmaceutical wholesale distributors, non-compliance with verification requirements can lead to suspended or revoked distribution authorizations, fines, and a damaged reputation.  Furthermore, manufacturers are liable for damages as producers.

In today’s social-media fuelled nonstop news cycle, bad news can spread around the world in the time it takes to send a tweet before containing it, or its context understood.  Verifying with Bonafi can help your business to avoid these negative consequences, and stay in compliance and in control of your reputation.

Bonafi Enables Your Business

Bonafi takes on the formidable verification tasks required by law so that our customers can get back to business.

Wholesale distributors must name a Responsible Person, whose many important duties include the verification of suppliers and customers according to EU Regulations. Bonafi bases its design and development on feedback from Responsible Persons and Quality Professionals from the pharmaceutical industry.

As a result, Bonafi is able to help our customers’ Responsible Persons to verify faster with repeatable and robust methods.

Good manufacturing practice demands that a computerized process be no riskier than a manual process. Bonafi is less risky than a manual process as we know what information you need and how and where to find it quickly. The World Health Organization (WHO) specifies that record-keeping systems follow data integrity principles.

Bonafi holds and secures your results as unchangeable and trustworthy. Also, it is built on reliable technology and tested & validated to pharma standards.

Bonafi Is a Trusted and Capable Business Partner 

Data integrity must begin with senior management. At Bonafi the commitment to securing the pharmaceutical supply chain begins at the top.

The EU’s good manufacturing practice guidelines provide that pharmaceutical businesses should outsource only to well-qualified, competent, and capable partners. By any standard, Bonafi is an outstanding outsourcing partner.


Complying with good manufacturing practice, the outsourcing partner must be knowledgeable, proficient, and capably-staffed to carry out the outsourced activities. Bonafi has the expertise, the knowledge, and the experience to complete the verification process, starting with our CEO. 

Furthermore, any outsourced database needs qualification in good data and record management practices. This, too, is Bonafi: ready and designed to be a trusted part of your pharmaceutical quality system. Bonafi commits to helping you follow industry standards and practices.

Committed to the Security of Your Supply Chain

Good distribution practice requires any computerised system to produce accurate, reliable, and consistent results. This is what Bonafi does.

Good manufacturing practice requires that data entry and processing be accurate and secure. We return accurate results that are secure in an unchangeable and traceable format.

Moreover, Bonafi complies with the “ALCOA” standard for data: our results are attributable, legal, contemporaneous, original, and accurate.

Importantly, Bonafi is ready for what comes next. Many in the pharmaceutical industry expect that the EU’s Falsified Medicines Directive will expand further. Bonafi is designed with this future in mind. Above all, Bonafi is ready for tomorrow – today.

Contact us today to learn how to receive Bona Fide Value for your Supply Chain and sign up for our Pilot Trial. Turn Your Months into Minutes!



Bonafi Limited

Suite B119
The LINC Centre
Blanchardstown Road North
Dublin 15, Ireland