Data Integrity in Pharmaceutical Sciences
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| Formato: | Recurso digital |
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2025
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| _version_ | 1866901842576801792 |
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| author | Apurva Shelke*, Aditi Shinde, Samruddhi Shinde, Karan Shinde, Saurabh Shinde, S. D. Mankar |
| author_facet | Apurva Shelke*, Aditi Shinde, Samruddhi Shinde, Karan Shinde, Saurabh Shinde, S. D. Mankar |
| contents | <p><span lang="EN-IN">The abstract highlights the importance of data integrity, especially in the pharmaceutical industry. It emphasizes that accurate and reliable data is essential for organizational stability and performance. The ALCOA principles (Attributable, Legible, Contemporaneous, Original, and Accurate) are recommended by regulatory bodies like the USFDA to ensure data integrity. Violations can occur due to data manipulation, inadequate procedures, or shared accounts. A study found that most breaches occurred in quality control (QC), with China and India having the highest number of violations. The study underscores the need for strong enforcement and strategies to maintain data integrity and improve regulatory compliance. </span></p> |
| format | Recurso digital |
| id | zenodo_https___doi_org_10_5281_zenodo_15185271 |
| institution | Zenodo |
| language | |
| publishDate | 2025 |
| publisher | Zenodo |
| record_format | zenodo |
| spellingShingle | Data Integrity in Pharmaceutical Sciences Apurva Shelke*, Aditi Shinde, Samruddhi Shinde, Karan Shinde, Saurabh Shinde, S. D. Mankar Data integrity, ALCOA, data, Regulation <p><span lang="EN-IN">The abstract highlights the importance of data integrity, especially in the pharmaceutical industry. It emphasizes that accurate and reliable data is essential for organizational stability and performance. The ALCOA principles (Attributable, Legible, Contemporaneous, Original, and Accurate) are recommended by regulatory bodies like the USFDA to ensure data integrity. Violations can occur due to data manipulation, inadequate procedures, or shared accounts. A study found that most breaches occurred in quality control (QC), with China and India having the highest number of violations. The study underscores the need for strong enforcement and strategies to maintain data integrity and improve regulatory compliance. </span></p> |
| title | Data Integrity in Pharmaceutical Sciences |
| topic | Data integrity, ALCOA, data, Regulation |
| url | https://doi.org/10.5281/zenodo.15185271 |