White Paper

Flying Blind: Data Visibility in Pharma

Visibility into the pharmaceutical manufacturing lifecycle is widely desired, but rarely obtained. What accounts for this gap between the need for data visibility and its scarcity in pharma?

June 7, 2022

Industry Perspective

Executive Summary

In Part 1 of this two-part series, we’ll explore the value and adoption of data visibility in pharma manufacturing. We’ll start with an overview of data visibility and its value for the enterprise, then move on to the common challenges faced by life science manufacturers when it comes to data visibility.

Lastly, we’ll consider the benefits manufacturing stand to gain by overcoming these blockers, with a focus on cloud solutions.

Jump to…

An Overview of Data Visibility

Let’s begin by exploring the definition and value of data visibility.

What is data visibility?

Data visibility is an organization’s ability to track, share, and analyze data from a variety of sources. Data visibility correlates to the speed at which this data can be captured and communicated. The faster the speed, the more visible the data.

Why is data visibility important?

Data visibility is important because it allows businesses to identify and resolve manufacturing problems in real time. Data visibility allows companies to make accurate, informed decisions about their business needs and priorities.

What is real-time visibility?

Real-time visibility means instant access to data across locations, products, teams and/or devices. Instead of manually logging and sharing sets of data, real-time visibility allows that data to be instantly distributed through the cloud.

The Power of Real-Time Visibility

What is real-time visibility for pharma?

In the pharmaceutical manufacturing space, real-time visibility means that data can be instantly viewed across sites and shared across teams. In other words, as soon as it’s captured, it’s instantly available to anyone involved in the drug manufacturing lifecycle.

Why is real-time visibility so important for pharma?

The need for timely visibility in pharma boils down to three main drivers:

  1. Lack of real-time visibility into production

    Monitoring information on the status of a batch, test method, standard or ad hoc procedure on paper requires operators to accurately document each step and resource usage. Records can only be reviewed periodically — and often post-completion and this results in precious time spent chasing missing entries and resolving errors.

    This is further exacerbated when the process is done within a CDMO due to higher product and batch volumes. In these cases, status updates are typically only available through calls, emails, and meetings.

  2. Lack of holistic visibility into facility resources

    Facility material, equipment, team resources and availabilities are constantly changing. That’s why the lack of visibility is especially difficult for resource planners.

    Determining which site locations and teams are best equipped to produce a certain product is difficult without a real-time view of the resources and locations available. A lack of visibility into continually changing resources prevents planners from accounting for the actualities they’ll need to face.

  3. Lack of built-in quality assurance

    When manufacturing teams are bound by manual data recording and transfer, Quality Assurance teams lack the means to review and resolve exceptions in the moment.

    Instead, they often discover exceptions months after they occur, necessitating a time-consuming and expensive paper trail to determine the root cause and address the impact.

“Lack of visibility and real time insights prevent the ability to quickly sense and respond to disruptions that could minimize impact on all partners and patients.”
—Roddy Martin, Chief Digital Strategist, TraceLink 

Data Visibility in Pharma: Surprising Stats

In October of 2020, International Data Corporation (IDC) and TraceLink surveyed over 500 pharmaceutical supply chain leaders to explore COVID’s impact on industry needs and challenges. Respondents included a mix of senior-level executives, supervisors, and operators.

Lack of upstream visibility emerged as the most problematic gap if left unaddressed:

A picture containing chartDescription automatically generated
Source: IDC and TraceLink’s Supply Chain Survey, 2020 (n=532)

IDC’s findings unearthed several surprising trends around this concern. Specifically, they uncovered a gap between identified needs for visibility in the pharma space, and planned solutions to address this need:

  • 70% of respondents agree that they are extremely vulnerable to facing more supply chain issues from the ongoing pandemic
  • 78% of respondents agree or strongly agree that timely visibility throughout the supply chain would dramatically reduce drug shortages
  • However, only 14% are actively pursuing end-to-end visibility solutions

It’s clear that real-time visibility is desperately needed in the pharma space. So, what accounts for the continuing resistance to exploring visibility solutions?

“Overall, the inability to respond to timely issues whether they are planned or unplanned is largely a function of the lack of visibility and the right data in the hands of the right team of leaders.”
—Simon Ellis, Program Vice President, Supply Chain Strategies, IDC

Data Delays in Pharma: Flying Blind

ShapeDescription automatically generated with low confidence

In pharmaceutical manufacturing, paper has long served as the means of logging and transferring data. It’s easy to see why: paper’s been around forever (for 1,917 years, to be exact).

Paper gives manufacturers an easy and familiar way to track their process. They can strike through what’s not needed, and make manual additions and initial and date.

However, when it comes to transferring that data, it’s no longer easy. Manual data transfer takes serious time and effort, and it comes with a long list of potential hazards.

Chief among them, errors, which often don’t get flagged until months after they appear.

“How do you design with quality if you have no control or awareness over everything that’s happening in the process? How do you achieve that control?”
—Laura Jacoby, Application Specialist, Apprentice

Delays are long and costly. They’re also hard to avoid when stakeholders aren’t aware of them until it’s too late.

It’s easier to send a binder of data at once, so Quality Assurance will often be out of the loop until they receive binders of data all at the end of the manufacturing cycle. This means that they cannot address or even learn about exceptions and deviations until the final hour — when product needs to be shipped.

Clearly, attempting to manage pharma data processing manually leads to errors, delays, retrospective data mining and burnout. However, on-premise solutions introduce problems of their own. 

Skyland Analytics strategist Ben Parker pinpoints five issues with traditional enterprise systems for pharmaceutical data processing:

  1. Ongoing costs
  2. Difficulty in transfer between systems
  3. Time needed for implementation
  4. Cumbersome to use, requiring dedicated specialists
  5. Lack of flexibility to meet the demands of shorter production cycles

Data Visibility in Pharma: Where We’re Headed

Clearly, paper is not sufficient to meet the growing demand for real-time data visibility in pharma manufacturing. Manually capturing, transcribing, and sharing data is just not feasible at scale.

A variety of digital solutions have emerged to surface data visibility at speed and at scale. They can be categorized into two main buckets: on-premise and cloud-based.

On-premise software, which companies can install and run on their own servers, might seem like an easy solution. However, it comes with numerous challenges that should not be overlooked:

  • Recurring costs from purchasing, managing, and governing in-house data center infrastructure
  • Total responsibility for all data outages, failures, and security breaches
  • Outdated hardware and software that needs to get manually updated in-house
  • Limited flexibility when it comes to scaling up and down, since these types of changes will trigger necessary changes to the on-prem environment 

To overcome these challenges, many savvy pharmaceutical companies are moving toward cloud-based solutions. On-premise environments might be a default or go-to option, but the cloud has emerged as an expedient and sustainable solution for growth-minded organizations. 

Cloud SaaS: The Future of Data Visibility in Pharma

ShapeDescription automatically generated with low confidence

In recent years, cloud technology has emerged as a path forward for providing a sustainable platform support at scale. Pharmaceutical leaders are turning to cloud software solutions to manage the growing demand for flexibility and availability. Currently, 16 out of the top 20 US pharma companies now use cloud technology in their digital strategy.

While cloud adoption continues to rise, use of the cloud to facilitate real-time visibility is still largely untapped in the pharma industry. 

This may be due to a lack of awareness of the cloud’s potential for pharma manufacturing, or resistance to adopting new technologies across the board.

However, one thing is clear, reducing latencies in data transfer is no longer a nice-to-have in life science manufacturing. 

To keep distributed manufacturing teams in the loop and on target, cloud-enabled real-time visibility has emerged as a top priority.

“As both regulatory guidance and technology capabilities continue to evolve, it’s important to ensure both systems and processes stay up to speed.”
—Cheryl Kole, Head of Solutions Strategy, Almac

Tempo for Real-Time Visibility in Pharma

ShapeDescription automatically generated with low confidence

At Apprentice, we believe in doing everything we can to make your lives easier. That’s why we built Tempo — our one-stop solution for real-time visibility across your sites, products and resources.

From preclinical benchtop to commercial manufacturing, Tempo keeps your global teams connected to crucial data in real time. Our cloud-based platform lets you instantly share and access data with the click of a button. 

Whether it is batch records, equipment or inventory usage, laboratory execution or real-time collaborative working that you need — you can find it all with Tempo. Discover Tempo.

Meet Our Data Visibility Champions

Here at Apprentice, our mission is to harness cloud technology to automate routine tasks like data capture and transfer. That’s why we built Tempo. 

With Tempo, your global production teams can operate in real time from a single shared system that contains manufacturing and lab execution system functionality with built-in collaboration. 

Got questions about our data visibility solutions? Our team of experts would be happy to talk data with you at your convenience! Say hello.

References

  1. Diaz, I. (2021, March 2). How Real-time Visibility Solves 4 Key Pharma Supply Chain Challenges. Roambee. https://blog.roambee.com/supply-chain-technology/how-real-time-visibility-solves-4-key-pharma-supply-chain-challenges
  2. IDC: These 3 Capabilities Will Help You Increase Supply Chain Agility. (2020, November 13). Tracelink. https://www.tracelink.com/agile-supply-chain/insights/idc-these-3-capabilities-will-help-you-increase-supply-chain-agility
  3. Jeff Berman, Group News Editor & Jeff Berman, Group News Editor. (2020, November 18). Survey issued by TraceLink and IDC cites various challenges for pharma shippers amid COVID-19. Supply Chain Management Review. https://www.scmr.com/article/survey-issued-by-tracelink-and-idc-cites-various-challenges-for-pharma-ship
  4. Parker, B. (2020, August 21). Enabling Data Visibility in Contract Manufacturing Networks. Skyland Analytics. https://skylandanalytics.net/articles-and-editorials/whitepapers/creating-cdmo-supply-chain-data-visibility/
  5. Spinner, J. (2022, March 1). Data history visibility keeps clinical studies on track: Almac. Outsourcing Pharma. https://www.outsourcing-pharma.com/Article/2022/03/01/Data-history-visibility-keeps-clinical-studies-on-track-Almac
  6. West, C., & de Muynck, B. (2021, July 26). How to Assess the Benefits and Return on Investment of a Real-Time Transportation Visibility Platform. Gartner. https://www.gartner.com/en/documents/4004052/how-to-assess-the-benefits-and-return-on-investment-of-a-real-time-transportation-visibility-platform
  7. Wyciślak, S. (2022). Exploring real-time visibility transportation platform deployment. Logforum, 18(1), 109–121. https://doi.org/10.17270/j.log.2022.660