Why Data Integrity is More Important Than Ever? : Pharmaceutical Guidelines

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Why Data Integrity is More Important Than Ever?

In pharmaceutical industry, you can't underestimate the importance of data integrity where life of any patient depends on the product.
Data integrity is an old concept that was first given in 1938 in Federal Food, Drug, and Cosmetic (FDC) Act but now in the digital age, it has become even more important. Every employee working in pharmaceutical industries must aware of the significance of data integrity including analyst, pharmacist or even housekeeper.

Data integrity has equal importance in all departments in the pharmaceutical industry from quality control to the purchasing department. By applying data integrity in the pharmaceutical production area can bring great benefits.
Data Integrity
1. With data integrity, you can rely on having accurate data, safe, efficient and high-quality products.
2. It creates trust between the company and regulatory agencies.
3. It is no longer needed to scan every process that is involved in the production and supply of your pharmaceutical products.
4. Efficient and trustful work environment.

To put it simply, by using data integrity in pharmaceutical manufacturing, you will be ensured with complete, correct and consistent data. It can be very useful in recalling products, complying with the arrangements and developing a great image of the company.

When it comes to data integrity, the data has to have these features:
  • There shouldn't be any human or automated errors.
  • It has to be developed, reflective and honest.
  • The data has to be original, meaning it shouldn't be plagiarized.
  • It has to be contemporary and it has to match the time zone of the place.
  • The data has to be understandable for the users and it should be stored in general language.

Why is data integrity important?
It's important because of the three key points.
1. The pharmaceutical industry and regulatory agencies have to have correct and sincere data to bring out the safety, efficacy and high-quality of a product.
2. It's essential to building trust between the company and regulatory agencies.
3. With data integrity, regulatory agencies don't have to look at the whole process and the creation of a product.
Related: ALCOA to ALCOA Plus for Data Integrity

How can I integrate data?
This is the question that you are probably wondering after reading all of this information. You can integrate data just by following these methods:
  • Keep your data safe, no one is allowed to change it or delete it.
  • Keep it stored to prevent theft or losing it.
  • Keep it saved in the form of true copies, correct reproductions with credits and original documents.
  • Data has to contain a complete appraisal of the testing, without having any failures.
The pharmaceutical industry must have a strategic focus on data integrity to make sure that the products are of high-quality and safe because it is the prime responsibility of the pharmaceutical manufacturers to manufacture a safe and effective product.
Related: Data Integrity as per 21 CFR Rules

Here we can conclude that data integrity in pharmaceutical manufacturing is very important. It is important because of the trust it builds not only with the regulatory agencies but with clients too. When you have trust built with those two, that creates a better image for your company and give your company the results it deserves. It also shows your determination to show how safe the product really is.

Regulatory agencies are also publishing guidelines on data integrity, FDA published data integrity guidelines in Dec 2018 and recently WHO published draft guidance on data integrity in Oct 2019.

We hope that it answered all the questions you had on data integrity and that we explained it to you how important it is. Now that you know all of this information, you only have to use it to create a better image for your company and to build trust with your clients and regulatory agencies.





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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