Importance of Data Integrity in Pharmaceuticals : Pharmaceutical Guidelines

Importance of Data Integrity in Pharmaceuticals

Data integrity is a common issue found during the most of the regulatory audits. In some cases data manipulated or changed to hide the original results.
These days, pharmaceuticals have started relying on computers and automated systems to a great extent, whether in terms of manufacturing, laboratory release testing or many other tasks involved. Due to this, a renewed focus has been brought to the concept of data integrity. It is the responsibility of the pharmaceutical industry to ensure the efficacy, quality and safety of drugs, and at the same time safeguard public health. This can be easily done with the help of data integrity if done in the right way. All this has led to the increased importance of data integrity in pharmaceuticals over the last few years.

Why Employ Data Integrity

According to experts, there are several benefits of employing data integrity practices in the pharmaceutical industry:
  • A product’s efficacy, quality and safety can be ensured with reliable and accurate data provided through data integrity.
  • Data integrity helps in building trust between regulatory agencies and the industry as a whole.
  • It eliminates the need for inspecting each and every process involved in the production and supply of drugs and other pharmaceutical products.
To summarize, data integrity helps by providing data that is complete, accurate and consistent. It is helpful in recalling products, complying with the regulations and improving company image in the industry.

Features of Data Integrity

In terms of data integrity, the data should have the following features:
When data is collected and recorded, it should provide information as to when, why and who created it
  • The data provided should be legible and should be stored in a general language.
  • The data should be contemporary and should match the time zone of the place.
  • It should be original and plagiarism free.
  • It should be free from errors, either human or automated.
  • It should be complete, reflective and truthful.

Rising Need for Data Integrity

Earlier, the regulated processes and quality systems of the industry were recorded on paper in the form of clinical binders, lab notebooks, batch records, procedures, recipes etc. The approval details were indicated with the help of dates and signatures written with wet ink. But today, the pharmaceutical industry has been digitized, and there are several advantages attached to it.
Related: FDA’s Top Data Integrity Issues Found During Inspections

Data integrity enables us to browse through the data faster, from a wide array of devices and platforms. We may also make copies of the data and take its backup to gain new insight into it. We can easily share data by way of emailing, uploading, downloading and others. Data integrity practices have given an all new kind of approach to pharmaceutical records.

How Can We Integrate Data

We can integrate data by following these practices:
  • Data should be safe and no one should be allowed to modify, delete or disturb it.
  • Data should be safely stored to prevent loss, deterioration and theft.
  • Data should be retained in the form of true copies, original records and accurate reproductions with credits.
  • The data should record a complete assessment of the test being performed, without failing to record anything.
The pharmaceutical industry should give instantaneous and strategic focus on data integrity practices to ensure the quality and safety of the data, and to create a less strict environment of regulations in the industry.





Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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