Have you ever found an Empower 3 chromatogram with no plot and the message “Incomplete Data”? You might have assumed that there was a system glitch, resulting in no data being acquired for the injection. However, data may have been acquired and can only be viewed if you have the appropriate permission(s). A search of the FDA’s website for this issue found three FDA 483 Inspection Reports where the FDA identified interrupted sequences that generated “Data Incomplete,” “Missing Data,” or “Bad Checksum” messages. In each case, the firm was not aware that the “Verify Incomplete Data” function could be used to retrieve and view the chromatographic data to determine whether any sample injections were within or out of specification, and the FDA concluded that the firm did not demonstrate an understanding of the circumstance(s) that may lead to such error messages. This discrepancy in the firm’s ability to review, document, and investigate all electronic issues was cited as a gap in the firm’s Data Integrity program.
“Bad Checksum” errors can occur when data acquisition is interrupted or the datafile is not closed properly.
If any Empower chromatographic plots display “Data Incomplete,” “Missing Data,” or “Bad Checksum” messages or any similar types of error messages from other Chromatographic Data Systems (CDS), then an investigation should be initiated (as per site procedures) to determine the root cause of the message, including verification of the incomplete data. If the verified data was found to be Out-of-Specification (OOS), then an OOS investigation is necessary. In addition, firms should understand how their CDS acquires, processes, and maintains the electronic raw data, including any error messages and their potential root causes that may arise during an analysis.
As per the Waters Knowledge Base, “Data Incomplete” can be verified by right-clicking on the chromatogram and selecting “Verify Incomplete Data” if you have the user permission available to your user group. If a datafile is displayed, then it can be saved and used. However, the data should be reviewed for completeness as not all acquired data may be usable.
If you have any questions about “Incomplete Data” in Empower or need help with the Data Integrity program at your organization, Lachman can help! Please reach out to us at LCS@LachmanConsultants.com.
