White Paper : Quality Management and Validation in Pharmacovigilance

March 14, 2019

Quality Management and Validation in Pharmacovigilance.

Why it’s critical for pharmaceutical companies to ensure their providers have an intimate understanding of drug safety regulations – and how they translate to software development.

Most people would agree that an amateur athlete with no clear understanding of the rules should never play in a world-championship match. That’s similar to a pharmaceutical company employing a drug safety software vendor without a proper quality management system – one which includes documented validation activities and training on GxP regulations – to provide software for pharmacovigilance. In both scenarios, a team effort is required to ensure that all regulations are met and, most importantly, harm is avoided.

Today, it’s common for pharmaceutical companies to implement software solutions  that simplify the workflow for pharmacovigilance. This software often aggregates and triages literature in a centralized location for the review and reporting of adverse events. However, despite stringent regulations that govern drug safety, many developers of pharmacovigilance software do not have any quality controls in place to ensure accuracy or precision. They leave these controls up to the pharmaceutical company.

Each year, regulatory authorities like the FDA and EMA issue hundreds of observations relating to IT software quality and validation management. Quality management, and specifically validation controls, in pharmacovigilance software development are critical – they allow for a repeatable and robust software development cycle in which a standardized approach is taken through the use of standard operating procedures (SOPs), process flows and industry best practices (such as code reviews). These controls eliminate software bugs with documented “tried and true” methodology, rather than ad-hoc approaches to development. This is paramount in decreasing and even eliminating regulatory agency observations – and gives pharmaceutical companies peace of mind that the results of their searches and reviews are inclusive and accurate.

However, there is much more to validated software than documenting and testing requirements. Without the quality management support structure for validation activities, validation is simply an exercise in running test scripts.

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