ARTICLE

How to Handle Digital Transformation in a Pharma Lab

Introduction

The emergence of the Internet of Things (IoT) has also underscored just how interconnected and digitally transformed pharma labs are becoming, with IT research firm Gartner estimating that in 2020 there will be over twice as many IoT devices in use than humans on earth. As more instruments and devices become connected to remotely hosted infrastructure such as public cloud computing platforms, pharma companies must perform a balancing act of risks juxtaposed to rewards.

No modern pharmaceutical lab is an island. In reality, it is brimming with instruments connected to PCs, Internet Protocol networks, and external services for tasks ranging from software patching to diagnostic monitoring.

The emergence of the Internet of Things (IoT) has also underscored just how interconnected and digitally transformed pharma labs are becoming, with IT research firm Gartner estimating that in 2020 there will be over twice as many IoT devices in use than humans on earth.


Managing the rewards and risks of Digital Transformation

As more instruments and devices become connected to remotely hosted infrastructure such as public cloud computing platforms, pharma companies must perform a balancing act.

On one hand, the information flowing to and from each instrument is vital to company-wide collaboration, as well as to drug discovery and development. It enables greater automation of such processes, within the context of growing pressures across the industry to accelerate development timelines while still containing costs. Connecting lab instruments to outside monitoring services capable of identifying underutilized or at-risk assets shows how further digitization of labs contributes to superior productivity.

On the other, data integrity and security become more germane concerns as a growing amount of sensitive information regularly moves beyond a company’s physical walls and firewalls. The deepening digital interdependence between technical systems, plus the particular processes in place for managing their lifecycles, can likewise increase risk for a pharma company, especially if there is a disconnect between its corporate IT and lab IT domains, as is frequently the case. Bridging that divide is critical.

Doing so and mitigating risk more broadly requires a digital transformation strategy, one supported by experienced strategic partners with extensive scientific and technical knowledge. Labs must start with a clear business case — most likely, boosting productivity —- that their ongoing digital transformation efforts are targeting. From there, they can work with those partners to build the consistent, scalable processes around tasks such as instrument monitoring, IT lifecycle management, and data integrity assessments and security monitoring, all to ensure a more productive environment.

The why and how of Digital Transformation in the lab

Digital transformation is not something that happens spontaneously or discreetly in a pharma lab. Companies weigh the risks and rewards described above and typically opt to pursue a controlled and continuous transformation, with a goal of obtaining the tangible benefits it can deliver over the long term.

For example, a lab outfitted with numerous interconnected instruments, cloud connectivity and easy access to analytics should allow for much faster decision-making and error correction than one in which equipment is more isolated. A 2018 episode at a major lab in Marlborough, Massachusetts, demonstrated the difference that such an IoT-enhanced lab could make.

In that instance, a high-performance liquid chromatography (HPLC) machine was producing erratic readouts. After a few failed attempts to identify the problem, lab personnel eventually installed a cloud-connected sensor near this HPLC instrument and analyzed the readings that it recorded to an electronic lab notebook (ELN). That data revealed that periodic air blasts from HVAC system in the lab were corrupting the HPLC’s accuracy at certain times of the day.

Without the advanced IoT connectivity in place, solving that issue would have taken much longer and required valuable time that could have been channeled into more productive endeavors. Similarly, remote lab monitoring solutions - like PerkinElmer Radian - have helped labs identify instruments on the verge of failure, so that they can be serviced or replaced before causing chaos.

These examples are instructive, as they show that while the basic value proposition of digital transformation (the “why”) is often clear enough, the precise steps necessary for realizing it (the “how”) are more technically involved. Indeed, there are multiple hurdles to overcome en route to sustaining a digital transformation effort and ensuring it keeps a lab connected and secure.


The unique requirements of lab instruments

Lab instruments aren’t like other computer assets. Whereas applying a routine security patch or software update poses low risk to a standard PC, it could easily break a lab instrument that requires distinct operating conditions. Some instruments also need a high level of performance from connected PCs, beyond what is necessary for most general-purpose computing tasks.

Growing digital system interdependence

The interconnections between instruments, PCs, and other infrastructure mean that a danger to one is a danger to all. Multiple components, from Windows PC clients to corporate servers, have to work in tandem to support standard lab operations – easier said than done. The age of some systems can make their obsolescence and retirement real issues, alongside the challenge of maintaining mixed IT environments with a variety of application types and versions.


Corporate IT vs Lab IT

Pharma-specific applications cannot always be governed the same way as enterprise IT counterparts. Following normal corporate IT guidelines could invite risks such as broken functionality after an update or alternatively technical overhead from unoptimized software or malware. Unfortunately, it often falls to scientists to spent their time reconciling the different requirements of corporate and lab IT. Lab outsourcing partners can help, but must be selected carefully.


Regulatory compliance

Data integrity violations are among the most common citations in FDA warning letters. Any digital transformation process has to have compliance baked in from the beginning. The implementation of computer-based instrument solutions, as well as informatics solutions like ELNs, must be handled carefully depending on how they intersect with regulated processes. Enlisting a compliance partner for assistance is advised, particularly during pre-product phases when nothing is yet in clinical trials.

Charting the right course through Digital Transformation

How can a lab begin harnessing the power of digital transformation while ensuring minimum disruptions and maximum security throughout the process and ongoing? It starts with gaining a holistic, 30,000-foot view of the purposes and effects of digitization across the larger laboratory organization, beyond their implications for the fires that a company attempts to put out on any given day.

Teaming up with strategic partners simplifies this journey, making it easier to navigate the demanding, instrument-by-instrument assessment and implementation processes required for effective and continuous digital transformation.

In addition to specialized tools for workflows like data visualization and remote monitoring, a partner provides the appropriate expertise integral to the long-term lifecycle management and futureproofing of lab instruments and applications.

Accordingly, labs can move toward reducing their footprints – namely, the costs and complexities associated with managing mission-critical technical infrastructure – and better work within their operating budgets.

Sources:

  1. https://www.labmanager.com/laboratory-technology/2018/05/how-the-internet-of-things-is-affecting-laboratory-equipment#.XUx7kTfYqt0
  2. https://www.the-scientist.com/bio-business/bringing-the-internet-of-things-into-the-lab-64265
  3. https://www.pharmaceuticalonline.com/doc/an-analysis-of-fda-warning-letters-on-data-integrity-0003
  4. https://www.mckinsey.com/industries/pharmaceuticals-and-medical-products/our-insights/digitization-automation-and-online-testing-the-future-of-pharma-quality-control