Data Integrity | A Critical Aspect of Pharmaceutical Industry

In recent years, the USFDA focuses on data integrity resulting in a rise in 483 observations and warning letters being issued for data integrity violations. These violations can have serious consequences, including regulatory action, legal consequences, damage to the company's reputation, and financial losses. Moreover, the FDA has the authority to recall drugs if they are found to be unsafe or ineffective, which can have a significant impact on patients who rely on these medications.

Data integrity is crucial in the pharmaceutical industry as it ensures that the data generated and reported is accurate, reliable, and complete. This data is used to support decisions related to drug development, manufacturing, and safety. Any manipulation or falsification of this data can lead to serious consequences for both the company and the patients who depend on their products.

To avoid regulatory action and maintain compliance with data integrity regulations, pharmaceutical companies must have a robust data integrity program in place. Here are some essential elements that should be included:

1) Clear and well-defined procedures for data handling (data collection, analysis & reporting) with clear and defined responsibilities.

2) Random verification of data

3) Robust SOPs, processes, policies and procedures

4) Implement audit trails and backups

5) Usage of electronic signatures and authentication

6) Validation and qualification of systems

7) Conduct quality risk assessments

8) Periodic data integrity review

9) Implement change control and promoting continual improvement, 

10) Promote a culture of integrity and ethical conduct within their organization. 

11) Employees should be encouraged to speak up if they come across any suspicious activities or behaviors related to data integrity. 

12) Regular internal audits and inspections to identify any gaps in the system/process/procedures and provide an opportunity to build the robust systems.

Read also:


  • FDA 21 CFR Part 11 
  • FDA Guidance for Industry Data Integrity Compliance with Drug cGMP 
  • EMA Good Manufacturing Practice (GMP) guidance to ensure Data Integrity 
  • EudraLex – Volume 4 

Resource Person: Bharathi Kodali

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