Conformance To Performance

How Pharmaceutical Quality Drives Performance

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The rapid growth of the pharmaceutical and biotechnology industries has been accompanied by an escalation in the complexity of drug-safety regulations -- particularly when it comes to data integrity. What seems like an almost daily onslaught of regulatory requirements for these organizations can be overwhelming, and it is especially so for emerging and mid-sized drug companies. Drug regulators in the United States, Europe, and the United Kingdom have responded to this growth and complexity by stepping up inspections in order to stay ahead of potential product recalls.

Over the past two years, the U.S. Food and Drug Administration (FDA) and the European Union Drug Regulatory Authorities (Eudra) have issued a plethora of warnings, recalls, and product bans across the globe. Almost 80% of the warning letters issued by the FDA in 2015 and 2016 cited: good manufacturing practices (GMPs), data-integrity failures in computer-system validation, laboratory audit trails, and maintaining electronic records and systems to track lost records. According to the FDA the number of warning letters specifically associated with data integrity jumped to 41 in 2016 from just 15 the prior year.

The profits of companies that receive warning letters are directly impacted as a result of lost productivity, increased downtime at manufacturing plants, product import bans and—in some cases—drug shortages. Despite the growing number of regulations, the number of Adverse Drug Reports (ADRs) continues to climb. Since 2000, the FDA has had more than 14 million ADRs, of which 1.4 million resulted in death. ADRs have surpassed 1 million since 2013 and have been nearing 2 million each year since 2015. The increase in ADRs and calls both inside the agency and from consumer advocacy groups have resulted in more determined and detailed government monitoring of production and efficacy.

Trusted By

Sparta Systems, a Honeywell Company, brings leading-edge quality management solutions to regulated industries. With nearly three decades of experience, Sparta provides enterprise and cloud-based QMS software solutions that help companies go to market faster while minimizing product risks and ensuring compliance. Sparta is an innovator in its field and is driving smart quality with first-of-its-kind AI-enabled quality solutions. By applying the latest digital technologies, our products simplify the process of quality management and guide customers toward proactive quality.

The combination of Sparta Systems and Honeywell brings together Sparta’s quality management leadership with over 100 years of industrial and software expertise from Honeywell. Together, Sparta and Honeywell will shape the future of digital quality and operational excellence for the life sciences industry.