Ankush, businesses in countless industries have been impacted by the pandemic, but few are being watched as closely as the pharma industry. What are some of the key challenges pharma companies are facing?

They are under significant pressure to produce drugs for prevention and treatment, and while they are doing that, they are facing global resource shortages, restrictions on importing API, social distancing at facilities, disturbed supply chains and time constraints. Regulators are likely to pay specific attention to how pharma companies are ensuring the health of their employees, maintaining safety protocols and the hygiene processes in place at research and manufacturing facilities. All of these in addition to the regular quality control and regulatory compliance standards and challenges they face under “normal” circumstances.

Data integrity is one of those regulatory requirements that pharma companies must always meet, but is potentially more difficult to maintain under today’s circumstances. Can you talk more about that?

Data integrity is viewed by regulators as an assurance of accuracy and consistency of pharma data from sources including the analytical equipment used in research and batch records of the products manufactured. It is mandated in the Good Manufacturing Practice (cGMP) guidelines, and by the U.S. Food and Drug Administration (FDA) and the Medicines and Healthcare Products Regulatory Agency (MHRA). The WHO has also issued guidance on data integrity, stating, “Risk-based system design and controls should enable the detection of errors, lapses and omissions of results and data during the data life cycle. Controls may include procedural controls, organizational controls and functional controls.”

The importance of data integrity can’t be understated—globally it is one of the most critical areas of risk management for the pharma and life sciences industry.

What are some of the risks that can result if data integrity is not addressed and maintained?

The consequences can be quite severe. I can share several examples. After one company received a warning from the FDA citing possible violations of manufacturing standards at three plants in India, it suffered a 15 percent reduction in market capitalization. In another matter, the U.S. government fined a pharma company $500 million for numerous CGMP failures. Other examples include massive losses in annual revenue and remediation following data integrity violations costing as much as $100 million.

And not only are the penalties severe, but the issue is quite prevalent. A global report found that roughly 50 percent of all Center for Drug Evaluation and Research (CDER) inspection observations issued between 2014 and 2018 cited data integrity violations, and during the same period, 79 percent of global warning letters issued by the FDA referenced data integrity issues.

So, even before the added pressures of the pandemic, this was a widespread challenge and risk. What do pharma companies need to do to address it?

Being proactive and taking cues from the FDA’s warning letters are good starting points. This includes focusing first on the specific violations found during inspections and heeding the FDA’s recommendation to, “retain a qualified consultant to assist in your remediation.”

Proactive efforts may include review and assessment of procedures identified in CGMP standards. Companies should also utilize advanced digital tools and technologies that can proactively identify data integrity lapses in electronic data of certain equipment (e.g. Chromatography Data Systems (CDS), NON-CDS, LIMS, etc.) and highlight those lapses on a real-time basis, so management can take necessary actions.

At FTI, we have supported a number of global pharma clients in establishing proactive data integrity programs as well as reactively remediating violations flagged by regulators. Our teams leverage advanced analytics to proactively identify issues in real time across large volumes of data from various systems. By establishing sophisticated monitoring and flagging of potential problems, we help our clients maintain forensically sound data management and audit trails and ensure secure access management processes. The result is a culture of data integrity, supported by technology, to withstand the demands of internal and external stressors like the pandemic.