Data integrity is the principle of generating, maintaining and assuring the consistent accuracy and completeness of data in a company or manufacturing plant through the entire life cycle complying with the regulations set within the pharmaceutical industry by the Food and Drug Administration (FDA). Data integrity compliance is the key issue to be looked into especially in pharmaceuticals because this is the most sensitive sector dealing with individuals health.
Real-time documentation is the most important thing to do when dealing with crucial data. Recording the data as it happens and updating any pending data to ensure that the records in the system match the changes made. Poor documentation leads to inconsistency and times can lead to raising questions that are hard to answer. Some times some pharmaceuticals may incidentally fail to do documentation to avoid questions especially when their main goal is to make more profits rather than saving a life.
Related: ALCOA to ALCOA Plus for Data Integrity
Related: Importance of Data Integrity in Pharmaceuticals
1. Data Documentation
Real-time documentation is the most important thing to do when dealing with crucial data. Recording the data as it happens and updating any pending data to ensure that the records in the system match the changes made. Poor documentation leads to inconsistency and times can lead to raising questions that are hard to answer. Some times some pharmaceuticals may incidentally fail to do documentation to avoid questions especially when their main goal is to make more profits rather than saving a life.2. Configuration of the Audit Trails
How is the audit history of the company? Regular audit history is essential for the transparency of the data security system within the organization. Some of the pharmaceutical industries lack the audit history not because they lack an auditor but simply because they are breaking some rules and would like to avoid risks of being asked questions. The configuration of the audit trails is a show of being accountable for all the operations within the organization.3. Testing Efforts
Is the testing efforts so duplicate in terms of the trust to the manufacturing plant? If the testing efforts are so duplicate, it means that the compliance measures are not trusted. The trend of the duplicate testing efforts clearly differentiates a company that adheres to the rules from the others and it also affects the documentation history of the company. This is a clear show to identify if a pharmaceutical industry complies to data integrity process. There is a need for clear predictable testing efforts trend.Related: ALCOA to ALCOA Plus for Data Integrity
4. Root of Quality Failure
Quality standards is a virtue that is being improved on a regular basis in every firm. If the quality standard is poor the firm needs to investigate the cause and improve on it. Failure in which it depicts that the firm data integrity compliance is not proper.Related: Importance of Data Integrity in Pharmaceuticals
5. Employees' Reaction to Regular FDA Inspections
Some of the companies train their employees on how to behave during the inspection time. It is a good measure to ensure that employees are not panicking when they see the FDA staff members. But the question is, why train them? Most probably there is something wrong somewhere and this is done to avoid contradicting answers from the employees that will cost the data integrity process of the organization. To avoid this, allow the employees access to the general firm's data. This will help the employees give correct answers that the inspectors can ask and also reduces the suspicion to the inspectors caused by panicking.
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