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Traditionally, pharmaceutical companies have often shied away from technological innovation for fear of falling into regulatory non-compliance.
The US Food and Drug Administration (FDA) has defined a framework -- referred to as Process Analytical Technology (PAT)
-- that promotes voluntary implementation of innovative pharmaceutical development, manufacturing, and quality assurance.
Specifically, PAT is a system for designing, analyzing, and controlling manufacturing through timely measurements
(i.e., during processing) of critical quality and performance attributes of raw and in-process materials and operations
with the goal of ensuring final product quality.
Quality by Design
TrakSYS™ is an effective Process Analytical Technology (PAT) enabler that safely introduces innovations that drive
productivity without risking non-compliance. TrakSYS takes the guess work and takes the guess work out of the
decision-making process by providing the required information to the right people – when they need it – regardless of where they are.
By analyzing the impact of a multitude of variables across the value chain on product quality, yield, schedule compliance, goal attainment,
and cost, TrakSYS™ empowers the stakeholders to make fact-based decisions that can deliver on the promise of quality by design.
That’s why many of the largest global pharmaceutical and medical device companies have chosen TrakSYS™ to be an integral part of their
operational excellence and continuous improvement initiatives.
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