Pharmaceutical audits find many cases of data integrity problems. Changing or modifying data in microbial analysis is easy because in most cases we can not save raw data such as petrips and test tubes.
Data integrity in the microbial analysis is to maintain the accuracy and assurance of data obtained from raw data. Treats very important data in the microbiological laboratory. On most occasions it is a mixture of authentic and qualitative data. It is more important to preserve pharmaceutical microbial data against vulnerabilities. Still, he did not pay much attention to the regulatory guidelines.
However, there are many people in the pharmaceutical industry who are overwhelmed by the concept of data integrity. And that's the main part of the concern. Apart from the prior knowledge of the people of the industry, we could not manage to integrate data integrity into microbial analysis. In order to hide test failures or product deviation, there is always an attempt to keep an immoral approach to microbiological laboratory, which contributes most to the lack of data integrity.
- Exclude data
- Error recording data
- Data is changing
- Deleting data
- Data loss
The Importance of Data Integrity in Microbial Analysis
The integrity of some microbiological data is different from those tested in other laboratories. Sometimes data can be more dangerous than data loss or more corrupted data. For example, study a week of environmental changes in low-quality clean rooms; If it is corrupted, then it is less essential to lose a failing imbalance test result.
In the case of data vulnerability, the data stored in a computerized system can be contaminated if it is not overlapped by conventional processes, unauthorized changes or handling. The purpose or unexpected handling of data can be prevented by keeping a good control over computerized system or with appropriate password access.
What causes data integration in microbial analytics?
The regulatory body FDA recently issued a letter, in which it has highlighted the data integrity issue. These data contributes to many reasons in the data concentration.
- Units of colonization are not counted while plates are counted.
- The pattern of the environmental study is such that the pattern is unplugged, it is not taken anywhere in the transit or incubator or it is not released.
- Finger dubbing does not take place properly as staff members leave the aseptic processing area.
- There is no reconciliation of paperwork and samples.
- Failed to record cleanliness or disinfection session.
- The worksheet is being jumped and the results are rewritten on the second sheet.
- There is no reconciliation of printed form.
- A problem with the computer system.
- Out-of-Limit results are not checked.
- A particular life is being recorded through the life of a microscopic identity or a non-match with the description of the colony.
- Proof of Microbial identification to get a good result.
The main components for strong data integration system
To create a good data collection system, we need to consider several factors. First, the laboratory needs to complete the procedure to analyze all samples tested in the laboratory. Most importantly, it is necessary to describe ways to measure the quality and acceptance of the data in the process.
Maintaining data integrity in microbial analysis is an important thing and only high-quality security. Finally, the data integrity of the pharmaceutical company can only be determined by the extremely capable and ethical standards through strict maintenance.
