During regulatory audits, data integrity is one of the most common issues. In some instances, critical data is changed or manipulated to hide the original outcomes.
Nowadays, more and more pharmaceuticals rely on a computer alongside automated systems, whether for laboratory release testing, manufacturing, and other related tasks. As a result, the spotlight is now on data integrity.
The pharmaceutical industry should take responsibility for ensuring that drugs are safe, quality, and effective to safeguard public health. This makes data integrity and security even more critical.
Data Integrity Overview
Data integrity is critical in any industry. That is especially true in the pharmaceutical industry since even the simplest error can lead to serious consequences. It is defined as assurance and maintenance of data accuracy and consistency throughout the life cycle.
Additionally, data integrity is fundamental to the system’s usage, design, and implementation that retrieves, processes, and stores critical data. If the pharmaceutical industry failed to maintain collected and recorded data, it is impossible to ensure that the products are safe and high-quality.
Data Integrity Principles
Principles of data integrity need to be standardized—that way, regulating them while getting improved processes and higher quality final products are a lot easier.
Each data has to be attributed to the people who generated it. It should include the person’s details and the timestamp. With Good Documenting Practice (GDP), identifying who recorded or changed the data is a lot easier.
All the collected and recorded data must be legible and permanent since many people have used the data multiple times. If a single person will only read the actual record, then the data is unusable.
Data should be recorded based on the actual time the work or action was done. There should be no data recorded retrospectively.
Having a medium where critical data was initially recorded is very important. It can be in the form of protocol, a database, a dedicated notebook. With a standardized recording procedure, solving multiple problems associated with data’s originality is not a tough job.
Data accuracy ensures that all data is complete, truthful, and error-free. It should also reflect the observations made.
Reasons to Employ Data Integrity
Employing data integrity offers several benefits in the pharmaceutical industry. The product’s safety, quality, and efficacy are ensured with accurate and reliable data through data integrity. It helps build trust between the pharmaceutical industry and regulatory agencies. Data integrity also eliminates the need to inspect every production process.
Overall, data integrity helps provide data that is consistent, accurate, and complete. It helps improve company image, complying with the strict regulations, and recalling products.
Data integrity allows the entire pharmaceutical industry to browse through data more quickly from different platforms and devices. It offers a brand new approach to collect and record data associated with pharmaceutical practices. The data must be legible and stored in a general language. It should be free from errors, complete, truthful, and reflective. Plus, it should be plagiarism-free. That way, the consumers can have peace of mind that all products produced by the industry are safe and high quality.