iSpeak Blog

FDA, Data Integrity, and the Dreaded Twenty-Five Words

Stephen Mahoney
ISPE 2017 Data Integrity (DI) Workshop

Just last week, a virulent strain of malicious ransomware wrought havoc in computer systems across the globe, dominating headlines, and precipitating a frantic rush to double-down on network security. The rapidity of the malware’s spread was a stark reminder of just how interconnected our systems have become, and the vital importance of our digital data. This interconnectivity is a double-edged sword. Remarkable opportunities exist in many industries—including ours—for innovation, collaboration, and globalization. However, electronic data likewise introduces a new set of challenges. Indeed, as the digital landscape plays an increasingly prominent role in pharmaceutical manufacturing, data integrity (DI) is an essential concern. In preparing for ISPE’s upcoming Data Integrity Workshop (4 June, in Arlington, Virginia), I reviewed the DI warning letters for the past few months and noticed something. They all contain the same twenty-five-word statement:

“Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture.”

This is a powerful sentence with serious implications. It can initiate regulatory or legal actions, including subsequent warning letters, seizures, injunctions, and withholding of any new applications or supplements. It creates a formidable obstacle capable of undermining years of effort and investment—potentially delaying vital treatment for patients. Yet despite this criticality, many companies struggle with key concepts of data integrity throughout the data lifecycle of their products. This underscores the complex challenges embedded in this deceptively simple twenty-five-word statement. Fortunately, ISPE is here to help you understand the fundamentals of data integrity by using practical, scenario-based problem solving, and case studies that simulate real-world conditions. Back by popular demand, ISPE is hosting a Data Integrity Workshop in Arlington, Virginia on 4 June 4 2017. A strong team of pharmaceutical industry and regulatory thought leaders are building upon last year’s sold-out workshop. This is an opportunity to deepen your understanding of key DI concepts to ensure the accuracy and integrity of your company’s data. This year’s workshop will include concurrent breakout sessions on:

  • Data Mapping/Process Workflows (essential for identifying potential data integrity risks)
  • Data Review/Forensic Tools (with focus on laboratory and manufacturing)
  • Data Integrity Governance – Maturity Model and Cultural Model (within the PQS)

Following these sessions, the workshop will conclude with an expert panel discussion led by regulatory and pharmaceutical industry representatives. We hope to see you in two weeks. With the knowledge gained at the DI Workshop, perhaps our industry can look forward to seeing this twenty-three-word sentence more often:

"Your quality system adequately ensures the accuracy and integrity of data to support the safety, effectiveness and quality of the drugs you manufacture."

Get up-to-speed on the latest developements surrounding this hot topic by attending the 2018 ISPE Quality Manufacturing Conference, which will feature an afternoon workshop dedicated to Data Integrity. 

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