Data integrity in the context of the pharmaceutical industry refers to the accuracy, completeness, reliability and consistency of data throughout its life cycle. This means that the data remains unchanged and must be available for use and review at all times.

Data integrity (German translation: Datenintegrität) encompasses several important aspects, including:

• Data integrity: No unauthorized or unintentional changes to the data after its creation.
• Completeness of the data: All data, including source data sets (translation into German: Quelldatensätze), results, analyses and reports, should be complete and accessible.
• Correctness of the data: The data should reflect the observations or test results without bias.
• Data consistency: The data should be coherent and consistent over time and space.
• Availability of the data: The data should be available for inspection, analysis and use throughout the entire necessary period.

Data integrity is of crucial importance in the pharmaceutical industry (German: Pharmaindustrie), as it has a direct impact on drug quality and safety. Breaches of data integrity can lead to false conclusions about the safety and efficacy of drugs, which can have serious consequences both for patient health and public trust in pharmaceutical products. Regulatory authorities such as the FDA (U.S. Food and Drug Administration) and the EMA (European Medicines Agency) therefore attach great importance to compliance with data integrity standards in clinical trials and in the manufacture of drugs.

If you would like professional language support for GMP inspections or audits of your pharmaceutical company, our specialists are happy to assist you. Our pharmaceutical interpreters and GMP translators interpret on site or, if required, online and prepare specialist translations of your pharmaceutical documents.