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Data integrity in microbial analysis refers to maintaining and ensuring the accuracy of data that is obtained from raw information. Microbiological laboratories handle a large amount of important data. In most cases, they are the combination of quantitative and qualitative data. Although protecting pharmaceutical microbial data against vulnerability is much more important. Still, it hasn’t gotten much attention in terms of regulatory guidance.
However, there are still many people in the pharmaceutical industry who are overwhelmed by the concept of data integrity. And that’s the main area of concern. Without the prior knowledge of industry people, we could hardly maintain data integrity in microbial analysis. To hide test failures or manufacturing deviations, microbiology laboratories often attempt to adopt an unethical stance, which contributes greatly to lack of data integrity.
=>> Omission of data
=>> Errors in the data recording
=>> Changing data
=>> Deleting data
=>> Destroying data
Importance of data integrity in microbial analysis
The completeness of some microbiological data varies from that of other data tested in another laboratory. Sometimes data can become more vulnerable than data loss or data corruption. For example, a week’s study of environmental changes in a lower grade clean room; if it becomes corrupted, then it is less essential than the loss of a single failed sterility test result.
In cases of data vulnerability, data stored on the computer system is more likely to become corrupted if it is not covered by conventional procedures, unauthorized changes, or tampering. Intentional or unintentional manipulation of data can be prevented by having good control over computer systems or by having a suitable access password.
