What Drug Manufacturers Need to Know About Data Integrity Compliance
In today’s highly digitized world, data integrity and computer system validation (CSV) compliance is of paramount importance within the pharmaceutical manufacturing industry. It is necessary to ensure the safety, efficacy, and quality of drugs, and to protect public health.
Regulators conduct regular inspections of drug manufacturing facilities to ensure manufacturers are GMP compliant. In the United States, for example, the Food and Drug Administration (FDA) sets the rules in Title 21 Part 11 of the Code of Federal Regulations (21CFR Part 11) to evaluate and enforce data integrity requirements for electronic records and signatures in drug manufacturing operations.
Over the last few years, the FDA has increased its scrutiny of data integrity and CSV programs implemented by drug manufacturers. This is especially the case if specific violations are occurring more frequently across the industry, in which case the agency will subsequently increase inspections to halt the trend.
If inadequacies are found during an inspection, a warning letter will be issued to the company with a timeline for remedial action. If, however, the violation could pose an imminent risk to human health— e.g., egregious gaps in a data quality program—company operations are shut down until the inadequacies are addressed. Any fine levied is commensurate with the severity of the violation.
The FDA periodically issues guidance for any notable trending problems and advises companies on how they can maintain compliance. The pharmaceutical industry and related professional organizations have also been developing guidance documents for industry-wide data integrity and CSV needs.
Trends and Best Practices
A growing trend in the drug manufacturing industry is the creation of corporate data integrity governance programs. These programs require a governance committee and data integrity manager to work together and develop data integrity policies and practices. For the program to succeed, the data integrity manager must have the knowledge and authority to implement and manage those practices.
A complete data integrity program must cover the full data lifecycle—from generation to archiving and destruction. For example, a particularly challenging point in lifecycle compliance has been adequate preparation for software or hardware transitions.
Manufacturers are now addressing data lifecycle challenges by increasing their focus on data integrity when considering instrumentation and software acquisitions. Meanwhile, hardware and software providers are integrating more robust data integrity capabilities into their new or updated products to support their customers. These proactive partnerships within the broader pharmaceutical industry can help drug manufacturers optimize their data integrity program.
Digital data integrity compliance has become a crucial component of drug manufacturing operations. As a result, the pharmaceutical industry, professional organizations, individual companies, and supporting partners are ramping up their efforts to address and standardize data integrity needs and processes. These multi-level efforts will support successful and compliant drug manufacturing in the future.