Data Integrity and Compliance for Research Labs

The consequences of poor data integrity can extend beyond the confines of a research lab to affect the general public. How do scientists keep up with the ever-changing and sometimes confusing guidelines of global regulatory agencies?

Data Integrity: The Plus and Minus of Technology

Development of sophisticated technology for lab equipment and supplies has been a double-edged sword. Many tedious and time-consuming jobs have been simplified, but the size and complexity of today's IT systems make it a challenge to implement and coordinate compliance measures.

In general, data integrity violations result from insufficient control over access to the collection and reporting system. As a result, the U.S. Food and Drug Administration (FDA) has been requiring audit trails that account for data each step of the way.

What Are the Consequences of Non-Compliance?

As the FDA works to enforce current good manufacturing practices (cGMP), remediation for violations may include:

  • A comprehensive investigation into the extent of the data inaccuracies.

  • A risk assessment of current operations and the extent to which data inaccuracies can affect patients.

  • A detailed corrective action plan including an analysis of the causes of the data integrity breaches as well as interim and long-term corrective measures.

  • Labs are finding more success in complying with regulations by taking a proactive approach rather than dealing with problems as they arise.

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