null Skip to main content

Data Integrity and Compliance for Research Labs

Posted by Stellar Staff on 3rd Jul 2017

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.

    Trust Stellar Scientific to handle your needs for top-quality lab equipment and supplies at prices that fit any budget.

    !