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Resource Guide

Data Integrity: Safeguarding your Lab’s Profitability and Reputation 

Regulations, tools, and expert guidance on how to protect data assets 

Safeguarding data integrity—the accuracy, consistency, and reliability of data—is multifactorial and involves robust security measures. Data integrity is critical to regulatory compliance, and secure, high-quality data is essential to preserve a lab’s profitability and reputation. 

Data Integrity: Safeguarding your Lab’s Profitability and Reputation

There are a number of ways that data integrity may be compromised, including instrumentation errors, poor record keeping, human error, and cybersecurity threats. Maintaining data integrity is challenging and involves managing the interaction between laboratory personnel and technology.

The FDA (The US Food and Drug Administration) introduced the ALCOA (Attributable, Legible, Contemporaneous, Original, and Accurate) and ALCOA+ (data is also Complete, Consistent, Enduring, and Available) principles to describe the most important data integrity requirements. The principles were originally intended for the pharmaceutical industry but have since been adopted by numerous others, including the healthcare and food and beverage industries.

Labs have access to a variety of tools to preserve data integrity. Quality management systems, data encryption tools, data backup and recovery systems, method validation software, and more can be implemented to safeguard data. Many modern instruments also have data integrity features such as electronic signatures and audit trails built in. With so many options, lab managers must carefully consider many factors to ensure the best fit for their lab’s current and future needs. In addition to these tools, it is critical to ensure proper training of lab personnel on data integrity procedures and develop comprehensive documentation protocols.

These principles and tools should be part of a holistic solution for data security that encompasses effective data management practices and fosters a culture of transparency within the organization.

Download the full resource guide to:

  • Gain new clarity on how to meet integrity criteria beyond ALCOA+
  • Discover guidance on selecting data management solutions 
  • Explore features of a compliance-ready ELN platform
  • Read expert advice to make regulatory inspections less daunting and more efficient

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