Data integrity is a common problem during most regulatory audits. In some cases the data was handled or changed to hide the original result.
Nowadays, medicines, computers, etc. have been largely dependent on the automated system, although there may be production, laboratory disposal tests or many other functions. As such, a new renewed focus has been brought to the concept of data integrity. Drug industry has the responsibility to ensure the efficiency, quality and safety of medicines and at the same time to safeguard public health. This can easily be done with the help of data integrity if done properly. In the last few years, it is increasing the data integrity of all medicines.
Related Article:-Data Integrity issues in microbiological analysis.
Why Employ Data Integrity.
According to experts, there are many benefits to using data integrity methods in the pharmaceutical industry:
- The effectiveness, quality and security of the product can be ensured with reliable and accurate data provided by data integrity.
- Data collection helps to build trust between the regulatory agency and the industry as a whole.
- It is necessary to monitor every process involved in the production and supply of medicines and other medicinal products.
To summarize, data integrity helps by providing accurate, accurate and consistent data. It is helpful to remind the products, to adhere to the rules, and to improve the image of the company in the industry.
Data Integration Features
In the case of data integrity, the data should have the following characteristics:
When data is collected and recorded, it must be provided when, why it is prepared and why it is created
- The data provided must be legible and stored in a common language.
- The data should be contemporary and match the time zone of that place.
- It should be free from the origin and the theft of the material.
- It should be free from both human or automated errors.
- It should be complete, thoughtful and truthful.
Increasing Need for Data Integrity
Prior to this, the industry's regulatory process and quality system Clinical Binders, laboratory notebooks, batch record, process, recipes etc. It has been reported on paper. The details of the sanction were indicated by date and by the initials signed by wet ink. But today, the pharmaceutical industry has been digitized, and has many advantages. Data integrity enables us to browse through detailed data and detailed data on platforms. We also copy the data and back it up to get new insights into it. We can easily share data with emailing, uploading, downloading and others. All types of new approaches are given on the pharmaceutical record with data integrity methods.
How we can integrate data
We can integrate data by following these steps:
- The data should be safe and no one should modify, delete, or disturb it.
- To avoid loss, deterioration and theft, the data should be stored safely.
- The data should be maintained in the form of real reproduction with original copies, original records and credits.
- Unless the data fails to record anything, the full evaluation of the test should be recorded.
Emergency and strategic focus should be given to the pharmaceutical industry to ensure data quality and safety and create a less stringent environment in the industry.
