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:
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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