Data Pedigree: The Foundation of Pharmaceutical Quality Control

Mack Powers | August 26, 2022

Quality is a top priority during clinical trials, as poor data quality can jeopardize patient safety and result in costly delays. Abundant data and numerous Silos make it difficult to track data provenance. Data pedigree can help ensure that data is of the highest quality by providing a complete history of where it came from and how it has been transformed over time.

What is Data Pedigree?

In the world of clinical research, data pedigree is a way to track the origins of data and ensure its accuracy. The term “pedigree” comes from the animal world, where it is used to track an animal’s lineage. In the same way, data pedigree tracks the journey of data from its original source through each step of data processing, analysis, and reporting. By tracking this journey, data pedigree can help ensure that the data is accurate and trustworthy.

A Data Pedigree Should Include

  • A short description of what the data depicts
  • The date the data was collected: This is important for understanding how old the data is and whether it may be outdated.
  • Description of the collection process: This includes a description of the procedure by which the data was acquired, such as a financial process, a healthcare process, a manufacturing process, customer service, etc.
  • A list of all the people who have worked on the data: This could be a research assistant, lab technician, data analyst, statistician, etc.
  • A description of all the steps that have been taken with the data: This could include data entry, cleaning, filtering, imputation, analysis, and reporting.
  • History of Data changes or data deletions with Timeframe
  • Details of the number of samples, measurement methods, and units
  • The location where the data was collected: This could be a hospital, clinic, research site, etc.
  • Information of Access to the gold document, i.e., the original data for verifiability

Can Data Pedigree Help Achieve FDA Compliance?

The short answer is yes.

Effective management begins with a rigorous plan and process to document, trace risks, and remediate them when they occur. Documentation is critical to show that a quality risk management process is in place, understood, and being followed. Data pedigree plays an important role in documenting the journey of data and ensuring its accuracy. 

The Food and Drug Administration (FDA) requires pharmaceutical firms to keep track of the origin of all data utilized in a clinical study. This includes not only primary data collected at the research site but also any secondary data that is used, such as data from electronic health records or other sources. 

In order to comply with these regulations, the clinical investigators must have a complete and accurate data pedigree for all data used in the trial. Data pedigree can help ensure that data is of the highest quality and provide a complete history of where the data came from and how it has been transformed over time.

Recently, Novartis was given a warning letter for record-keeping inadequacies, quality concerns, and cleaning deficits at its Millburn, New Jersey, plant. The deficiencies were uncovered during an audit of the facility. One of the issues cited in the warning letter was the lack of complete documentation for some of the products produced at the plant. The FDA noted that Novartis had failed to keep track of the origins of certain data and how it had been processed over time.

From the above example, it is clear that pedigree is a valuable resource for FDA audits. In the event of an audit, data pedigree can help show that data is accurate and trustworthy. This can help pharmaceutical companies and clinical research organizations avoid warning letters and costly delays and ensure that patient safety is not compromised.

The Benefits of Data-Driven Approach to Quality Improvement

Solve Quality Problems More Quickly

By understanding where data comes from and how it has been processed, quality teams can more quickly identify errors and investigate root causes. This can lead to faster problem-solving and improved quality of care.

Improve Communication Between Departments

Data pedigree can help improve communication between departments by providing a clear understanding of the data and its origins.

Trace and Track Data Throughout the Supply Chain

Effective tracking and tracing of data from raw data to finished products can help ensure data efficiency, quality, and security throughout the supply chain. 

Guide AI /Machine Learning Models

To train AI/machine learning models, it is important to know the history of the data. Data pedigree can provide this information and help ensure machines are trained to make informed and unbiased decisions.

It Helps You Stay Competitive

Data-driven approaches allow organizations to compare their performance against best practices and industry benchmarks. This can help organizations identify areas where they need to improve and stay competitive.

Enables Compliance

With a proper pedigree process in place, pharmaceutical companies and clinical research organizations can achieve compliance with FDA regulations. This can help avoid recalls and ensure quality conformance.

The benefits of using data-driven approaches for quality improvement are clear. Organizations that embrace these methods will be able to improve the quality of their products or services while reducing costs and improving efficiency.

The bottom line is that data quality is critical and an integral part of the quality control process. Pharmaceutical facilities must have a documented pedigree of data to ensure accurate results. Without data pedigree, quality teams will have a difficult time troubleshooting quality issues and ensuring compliance.

Know Where You Stand With Data Pedigree

The correct analysis of the data is situation critical. Pharmaceutical Success is directly related to the accuracy of this data. What mechanisms do your company use to validate the data quality? Are they prepared to respond to any FDA inquiries if they come knocking?

We at Integrao can assist you in examining your systems and operations to identify places for improvement. We can also work with you to create a data pedigree that will withstand any FDA scrutiny. Contact Us to get started.