Identifying and Mitigating the Risks and Challenges of Pharmaceutical Digital Transformation

Digital transformation projects and initiatives deliver considerable benefits to companies in the pharmaceutical industry. Digital transformation modernizes operations, improves efficiency, reduces costs, and enhances patient safety and quality.

Digital transformation projects and initiatives are also often complex, they require increased levels of connectivity, and they often involve the introduction of new technologies. As a result, there are risks and challenges that must be identified, assessed, and mitigated.

Common Risks and Challenges of Pharmaceutical Digital Transformation

It is essential to carry out risk assessments when planning a digital transformation project. All pharmaceutical facilities are unique, so specific risks and challenges can vary. That said, they often come under common headings:

Integration

Difficulties can arise when integrating systems and equipment, especially legacy systems.

Data Silos

Data silos are common in the pharmaceutical industry, from paper-based records to unconnected systems.

Data Standardization

Historically, there has been no standard data protocol followed by vendors who create systems for the pharmaceutical industry.

Cybersecurity

Companies in the pharmaceutical industry are at high risk of a cybersecurity attack, so cybersecurity must be factored into all elements of digital transformation projects.

Regulatory Compliance

There is a range of regulatory issues to consider during digital transformation projects, including ensuring new processes are compliant and new technologies are properly validated.

We can use a recent project at one of our pharma industry clients as an example. The customer has a small manufacturing site where there were questions about if and when this plant would fall under regulatory authorities. The plant was not directly delivering finished products but was an intermediate supplier to an end manufacturer.

Westbourne helped this company deliver a modern IT infrastructure and systems. When the time was right, we implemented a computer systems validation (CSV) policy for the plant, mitigating risk for our client.

Data Privacy

Digital transformation projects often involve an element of data digitalization. Even data that is currently in digital form can be digitalized, i.e., utilized for things like performance improvement or predictive analysis rather than being simply recorded in digital form. Therefore, data privacy factors must be considered throughout.

Change Management

Compared to other industries, the pharmaceutical industry has been slow to adopt digital transformation technologies and solutions. The reasons for this include patient safety, quality, and compliance.

Skills Availability

Companies in the pharmaceutical industry can lack the in-house skills required to plan and implement digital transformation projects and initiatives.

We resolved this problem in a recent project for one of our pharmaceutical industry customers. The customer required a Lab IT lead at a new manufacturing plant to coordinate engineers, implement ServiceNow within the department, and optimize periodic review processes for IT systems within the Lab.

As well as providing some of the technical resources, Westbourne supported the project lead to drive the digitalization initiative forward. This involved working with management for coordination, local and global IT teams for ServiceNow, and the QA team for optimizing the periodic review system.

Our relationship allowed the customer to transfer the risk of having underqualified staff working in a highly regulated environment.

Downtime

Operational downtime and the impact on output are essential considerations, especially during the installation and commissioning phases of a digital transformation project.

IT/OT Gap

There is often a disconnect between the IT functions and OT (operational technology) functions in a pharmaceutical company. As digital transformation projects often involve enhancing the integration and interoperability of IT and OT systems, steps should be taken to bridge the gap.

Tips for Mitigating Digital Transformation Risks and Challenges

Choose the Right Partner

Implementing digital transformation projects and initiatives involves working with specialist providers. It’s important to select a partner that has experience not just with digital transformation but also experience in the pharmaceutical industry. A digital transformation partner with pharmaceutical experience will understand the unique operational, compliance, and technical challenges you face.

Assessment and Planning

The assessment and planning stages of any digital transformation project are critical for mitigating risks and challenges. The best approach is to identify and mitigate risks and challenges as early in the process as possible, rather than coming to them at a later stage.

Using project managers in your lab environment is important for good assessment and planning. In a recent project for a pharmaceutical customer, we were called in to provide project management and lab systems support as the in-house laboratory analytical team was finding the workload overwhelming. Westbourne mitigated the risk of project failure by employing a Lab IT Project Manager to coordinate major changes.

Stakeholder Involvement

One of the biggest mistakes that can occur when implementing digital transformation projects is to think of them as purely technical exercises. The reality is that the success of many digital transformation initiatives lies with people, especially those closest to the frontline. If laboratory and/or production staff don’t buy in, progress can be stalled.

The solution is to involve all stakeholders throughout the process. This will produce a better-quality solution as you can use the knowledge and experience of those most involved, as well as mitigating change management risks.

Pilot Project

Focusing first on a pilot project helps prove the value of a digital transformation concept before a more widespread rollout. You can also use the pilot to learn lessons within a more confined and controlled risk environment.

Unified Data Framework

Integration, data silos, and data standardization issues are key challenges to overcome when implementing digital transformation projects in the pharmaceutical industry. There are many technical solutions that can be used to overcome these challenges, especially if they are taken in isolation.

However, the best approach is to implement solutions that can be scaled under a common framework. An example is developing a UNS (unified namespace) architecture using the MQTT communication and data exchange protocol.

UNS is a hub-and-spoke data exchange and communication model that is significantly more scalable than point-to-point connections. Combined with MQTT, the commonly recognized OT communication protocol, you can standardize data, overcome integration challenges, and break down data silos.

Holistic Approach

It is also important to take a holistic approach where all factors are considered and factored in from the start. Key examples are compliance and cybersecurity. On the compliance front, each step should be documented, and new technologies should be validated using robust CSV processes. And cybersecurity should always be at the top of the priority list, especially during vendor selection phases.

At Westbourne, we have found that small companies can be vulnerable because validation and cybersecurity are diverse IT skills. Becoming competent in both simultaneously can be challenging for a small company. You can mitigate this risk by getting the right insurance, appointing a senior IT manager for cybersecurity, and partnering with an industry expert for validation.

Mitigating Pharmaceutical Digital Transformation Risks and Challenges

Mitigating the risks and challenges that can arise in pharmaceutical digital transformation projects requires a combination of people, processes, and technology.

We can help at Westbourne, both in terms of implementing digital transformation projects and ensuring the risks and challenges are properly identified and mitigated. Get in touch with us today to arrange a consultation.

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