Perspectives

Master data management for pharma product data and information

Building readiness for global regulations

​​In addition to achieving compliance, master data management (MDM) can bring many benefits to pharmaceutical companies. Learn how MDM can help your organization improve speed and efficiency across the product life cycle.​

Increased data clarity and consistency

​As part of their obligation to communicate accurate and changing product information to regulators throughout the life cycle of a product, pharmaceutical companies will have to adhere to new product master data standards for identification of medicinal products (IDMP) and the US Food and Drug Administration's Draft Standardization of Pharmaceutical Quality/Chemistry Manufacturing and Control Data Elements and Terminologies (PQ/CMC). But master data management (MDM) is likely a more enduring and far-reaching concern—and regulatory compliance is only one of many reasons to put a strong MDM discipline in place.

The discipline of MDM is designed to treat enterprise information as a strategic asset and govern it so it provides end-to-end business oversight, a foundation for strategic capabilities, and operational excellence. But master data management is more than an IT issue—it's a business need. Successful MDM programs include strong business leadership and commitment.

MDM offers more than just a cleaner path to regulatory compliance. As better, more accessible data helps streamline processes and speed strategic decisions backed by analytics and data-driven insights, the resulting clarity and consistency can also drive internal benefits. It can also leave organizations better prepared to satisfy information needs, whether from other company functions, governments, or other third-party partners such as CROs and CMOs. And can help simplify mergers and acquisitions.

Clearly, a better mastery of data, its accuracy, and its integrity is worth the effort it will take to conquer today's informational silos. A deliberate approach to MDM can establish common terms of reference and pave the way to working with standards. So while IDMP and PQ/CMC are the new standards on the radar right now, they aren't the only changes unfolding in the industry. The broad application of MDM across product data management would be long overdue with or without new standards. 

What is master data?

​By definition, it's information that is uniquely identifiable, accurate, and shared across multiple business transactions. Business functions and even third parties can share it easily without data translation, and everyone across the organization agrees on its definition, standards, accuracy, and authority.​

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Mastering product data management

New regulations like IDMP and PQ/CMC are part of a trend toward more transparency, traceability, and standardization. They are also a response to a worldwide demand for better data quality and cross-border information exchange to support use cases such as patient safety, falsification of medicines, and electronic prescriptions. If the mandate is adherence to and the use of standards, then mastering product data is a necessary precursor to making that happen.

Whether a company is launching a new manufacturing site, changing a machine on an assembly line, or changing a label based on a newly discovered drug interaction, health authorities in each jurisdiction need to know about product information changes.

But the information necessary to recognize, collect, and report these changes more efficiently often resides in separate places. Different systems use different vocabularies to manage, search, and communication product data, and operating across those divides makes it harder to link product data together.

The result is typically a cascade of inefficiencies: Data entered multiple times into multiple systems using different vocabularies, manual double-checking and verification across systems, inability to link and report on information across systems, delayed or unclear communication among departments, and a failure to derive the insights quickly that data should yield.

In contrast, organizations that use MDM find they can work with an unprecedented level of data quality, integrity, and transparency. Standardization of product information and controlled vocabularies is a crucial step.

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Getting started

Pharmaceutical and biotechnical companies are under pressure to deliver more consistent data with integrity that lives up to increasingly stringent standards. Regulations like IDMP are a prominent source of this pressure but not the only one. To answer the call, organizations will first need to master their own information, starting with detailed product information. MDM is a discipline that can make that happen in an organized, governable way.

Short-term benefits will likely appear both inside and outside the company. In the long run, regulators and patients can benefit from the linkage that occurs when global agencies and health care systems all share the same standardized product data and safety information.

Because IDMP and similar mandates involve multiple interactions with multiple health authorities over a span of years, organizations should plan an iterative MDM solution—but not a leisurely one. By using tools to capture and curate data over the long haul, companies can position themselves ahead of the game and can be ready to meet new requirements as they arise.

Regulatory compliance may be the reason you take on MDM today. But the journey doesn't end there. When done right, a strong, foundational MDM solution will help support ongoing data quality maintenance and controls and drive compliance and operational efficiencies in many areas for years to come.​

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