Master Data Management

The Three Root Causes of Data Dysfunction in Life Sciences — and How to Fix Them

In the fast paced, ever evolving, yet highly regulated Life Sciences industry, a well-structured Master Data Lifecycle Management strategy is essential to support companies through their growth transformations. However, organizations often overlook the impact of master data by assigning ownership to IT support or shared service functions rather than to the cross-functional business areas that generate and rely on this data such as finance, supply chain, R&D and others. This misalignment can lead to data inconsistencies, compliance failures and operation inefficiencies, ultimately impacting patients by delaying time-to-market and compromising product safety.

Consequently, many organizations fall victim to the “Firefighting Vicious Cycle,” a reactive-state pattern consisting of constant, arduous manual work often caused by three factors: insufficient governance, siloed operations and lack of master data standards.

The Life Sciences industry requires accurate, reliable and timely data throughout its product lifecycle stages to ensure smooth operations, regulatory compliance, financial accuracy, successful product launches, and most importantly, positive patient outcomes. The following sections explore the operational breakdowns caused by poor master data management — and how to resolve them through a structured, cross-functional strategy.

Understanding Master Data Management

Master Data covers everything from customers, products, sites, suppliers, materials and financials. It spans pre-clinical research, clinical trials, process performance qualification (“PPQ”) runs, commercialization, manufacturing, delivery to patients, post-launch market surveillance and end of life (e.g., patent expiry, product retirement).

Master data management refers to the process of ensuring the accuracy, consistency and reliability of core business data related to products, customers, suppliers, clinical trials, etc. It ensures that such data is properly governed, maintained and integrated across all relevant business processes, from research and development to product delivery.

The “Firefighting Vicious Cycle” and the Three Root Causes

The Firefighting Vicious Cycle refers to a phenomenon when organizations fall hostage to their lack of master data ownership and maintenance and rely on arduous, manual workarounds as the only way to support continuous operations. The Firefighting Vicious Cycle often stems from three inter-related root causes:

Insufficient governance: Without clear ownership, oversight, responsibilities, accountability, and because entered data isn't being policed to maximize usability, data quality suffers, often leading to root cause #2.
Siloed operations: If functions operate independently, critical data can become segregated and often duplicated, causing gaps in communication and decision-making, and causing teams to generate similar data separately, leading to problems down the road when data parameters do not align. When siloed operations are the norm, it enables root cause #3.
Lack of master data standards: Inconsistent guidelines, definitions and procedures across functions increase data discrepancies and obstruct master data signals through the product lifecycle, making launch readiness and daily operations reactive rather than proactive processes.

This is a cycle with no end nor beginning, as any of these root causes can be an enabler of the others. As these issues compound, companies are driven into a reactive state of operation to focus on immediate problems, often at the expense of long-term growth and strategic planning.

To address the cycle from within, ownership (governance), maintenance (standards), and collaboration (break down siloes) practices must have a clear master data source of truth with owners for every data field in addition to a clear process for when every data field is updated, by whom, and how.

How the 3 Root Causes Erode Performance

In the Life Sciences space, the most common challenges pertaining to master data typically arise from three root causes, which, if not addressed early, can impact various aspects of the organization. To expand upon the previously mentioned root causes, we typically see these factors leading to the following types of impact:

Insufficient governance can be identified when there is no clear understanding across the enterprise of “who owns what,” or a general assumption that “someone else will handle this task” without knowing who that person or team is. This leads to:

A lack of accountability, delays in completing initiatives and discrepancies between perception and reality within different governance structures or levels of the organization.
Confusion, causing teams to waste time solving for accountability “gaps,” ultimately increasing costs and delaying time-to-market.

Siloed operations are evident when different functions involved in the master data processes are consistently unaware of the activities and efforts being performed by other groups. This lack of communication can lead to:

Asynchronous functional activities such as delays in product launch, mismanaged ordering or production schedules and generally wasted resource efforts.
Reduced operational agility, higher resource drain and higher employee dissatisfaction and turnover.

Lack of master data standards becomes noticeable when:

Key members of different functions are not able to promptly define important terms, definitions, protocols, processes and procedures.
The business is exposed to risks such as people-dependence, breakdowns in business continuity, ineffective onboarding and errors in critical processes — ultimately increasing the likelihood of regulatory, quality and reputational issues.

7-Step Roadmap to Breaking the Firefighting Cycle

A thorough master data lifecycle management strategy, when properly and proactively designed and sponsored by cross-functional leaders, can address the root causes of the Firefighting Vicious Cycle through the following roadmap:

Develop a master data management vision that ensures data quality, accessibility and consistency to support decision-making that ultimately benefits patients.
Define requirements and create a master data source of truth for materials, customers, suppliers and sites, focusing on quality and regulatory compliance.
Identify the responsible parties and owners for each data field, including who will be responsible for maintenance and schedules for data field updates.
Map master data lifecycle activation across the end-to-end process (i.e., where each master data element becomes available throughout the product lifecycle).
Foster cross-functional cooperation by documenting governance and promoting cross functional collaboration throughout the product lifecycle.
Document standard processes, policies and procedures for daily operations, training and onboarding and business continuity planning.
Centralize data to enable and integrate cross-functional insights and collaboration in one platform.

Case Study: Master Data Strategy and Transformation in Vaccines Manufacturing

Background: FTI Consulting was engaged by a large biotech vaccine manufacturer to assess their bill of materials (“BOM”) and SKU master data lifecycle management processes (e.g., creation, maintenance, and obsoletion) and help design a future state process that supports the global launch of future pipeline products while optimizing data management for the existing product portfolio.

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Outcome: Through root cause analyses, gap assessments and the deployment of a cross-functional change management plan, FTI Consulting designed a future-state process that supports product evolution from pre-clinical research through commercial launch using a unified system and consistent procedural guidelines. This enabled launch-ready process improvements that allow proactive signaling and tracking of critical master data across the entire product lifecycle, ensuring data availability for current and future pipeline products and significantly reducing the need for reactive firefighting as a means to achieve more successful product launches.

In Conclusion

A well-planned and properly executed Master Data Lifecycle Management strategy not only enhances the business’ ability to perform in the competitive Life Sciences industry but also directly affects patients by ensuring that products reach the market on time and in full compliance with regulatory and quality standards.

FTI Consulting understands and partners with companies facing growth transformations and has a track record of helping organizations develop their master data management strategy to ultimately improve decision-making, regulatory compliance, operational efficiency, and centralized governance to help better serve patients around the globe.