Data corruption in Pharma Manufacturing Business Process

The hidden dangers of compromised data and methods to avoid/remediate data corruption in Pharma Manufacturing Business Process. 

Complying with data integrity regulations and guidelines is a mammoth task. There are costs involved in conducting a gap analysis, writing procedures, developing action plans, training staff, and changing IT systems. In the worst-case scenario, you may need to get rid of the old systems and replace them with new ones. 

These challenges are based on the emergence of the widespread manipulation of data and failure to comply with good manufacturing practices (cGMP) regulations. In order to improve data integrity, follow this assessment approach. 

Data integrity is important in drug and medical device development. It enables regulators to determine a product’s safety, efficacy and quality. It also creates a trusting relationship between regulators and any entity involved in developing the product, including industry and its contractors. 

Trust is an integral part of the pharmaceutical drug evaluation process. It can be shattered by the abuse of that trust, but regaining it is often a long and difficult task.  

• Depending on the size of the production facility, regulation agencies cannot audit and inspect all the behaviors, procedures, and technical aspects of each pharmaceutical company’s production processes. 
• Only with integrity in its data can a firm prove it is complying with regulators’ guidelines and expectations. 
• Drug companies demonstrate the consistency and scalability of their products by keeping accurate, complete, and consistent records throughout their products’ lifecycles. 
• If the pharmaceutical industry cannot provide evidence of safety, it faces facility closure, product recalls, import and/or distribution bans, delays or blocked drug approvals, reputation damage, and more. 
• Also, their regulator may impose stricter scrutiny on them in the future, which will lead to more frequent inspections. 

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Will data integrity issues still be a problem in the future? 

The Food and Drug Administration (FDA) wants to prevent accidents in the manufacturing of food products, because data integrity breaches can lead to health problems. In particular, the FDA seeks to stop offenders who alter their records and data, or deliberately misrepresent them. Information from an FDA report indicates that the following practices have been identified as causing potential harm to consumers: 

• Failing to provide the data needed to support a test’s results or destroying that data results in the loss of valuable information. 
• The repetition of a test, experiment, or survey in order to get a desired result. 
• Lack of effective security measures can lead to unauthorized access to technical systems. 
• Falsely recording transactions to make them appear to have occurred at an earlier date. 
• Despite the availability of automated auditing programs, many organizations take away their audit trails. 
• “Shaping” test equipment settings to produce out-of-specification data can be deemed fraudulent by lab technicians and quality assurance personnel. 
• The approval for a project is given by people who are no longer employees of the company. 

Compliance is a major cost for pharmaceutical companies and not without reason. The instruments and technologies used to manufacture drugs are becoming increasingly sophisticated, making the recording, monitoring, and auditing of these activities and procedures more complicated. Just as outsourcing has become more common, cloud-based technical architectures, automation, and mobile technologies are also becoming indispensable. 

It may be difficult to keep data accurate. 

Pharmaceutical companies must place a focus on the human element in order to maintain proper data integrity. If an organization assumes its money will be stolen, it is unlikely to take steps to prevent such thefts. Similarly, if a company assumes that some employees will tamper with the data, that company can protect itself by training and informing employees about the impact their actions will have on the data. Management must also hold those employees accountable for adhering to the organization’s policies by making sure that appropriate action is taken when policies are violated. All members of an organization play a role in maintaining data integrity, from entry-level employees to senior management 

The people responsible for data integrity need to be taught more about their roles and responsibilities. The following people should be taught more about it: 

• System administrators – System owners are people within an organization who are responsible for managing a computer system or component. 
• Quality assurance officers and quality control technicians observe the production processes of their company’s products. 
• The department of information technology and engineering is responsible for helping to protect our computer networks, among other services. 
• The owners of a process or data item are accountable for the accurate and timely assessment, management, and status reporting of their respective items. 
• Personnel whose job it is to certify compliance with regulations and to ensure that employees seek and receive permission before taking certain actions. 
• The company specializes in providing outsourcing services for information technology and business processes. 
• System maintainers, developers, and users have an important relationship that needs to be maintained. 
• Clinical and manufacturing professionals work at pharmaceutical, biotechnology, and medical device companies. Laboratory professionals work in scientific research, academic or medical institutions, or private laboratories. 

When an accidental or intentional data breach occurs, it is important for a company to clearly state its responsibilities in response to such events. 

Data integrity management is challenging because of the human and cultural factors involved, but it can be managed. Physically maintaining a computer system is laborious and intrusive, but why is this so? 

• Pharmaceutical development and manufacturing are complex processes requiring adherence to strict guidelines and use of technology-driven solutions. The result is significant data being generated from the creation and testing of drugs to the manufacturing of final products. 
• Validate your computer systems and business processes to ensure the accuracy of your data. 
• To protect data and prevent integrity breaches, administrators must manage access rights and critical authorizations. 
• Regular review should be conducted to establish a secure, time-stamped record of data activity and an audit trail of the activities of users of each system. 
• Due to the hundreds, if not thousands, of systems involved, this process can be time-consuming and disruptive. It is prudent to verify each system individually.