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European Biopharmaceutical Review

The Elegant Fundamentals




It’s impossible to overstate the importance of accurate data in the pharmaceutical supply chain for the purposes of visibility, traceability, and patient safety. Without accurate data, your products may not reach your customers, or may fail to meet global market requirements. Without factual data, you jeopardise pharmacovigilance, or drug safety, which includes combatting falsified medicines. Without ‘truthful’ data, your operations will falter, and your markets will disappear.

Data integrity has always been a pillar of GMP, but it has become even more important in recent years. High-quality data in supply chain traceability systems is the foundation for analytics and data-driven technologies such as artificial intelligence, machine learning, and blockchain. If the data are bad, then the output from these systems will at best be suspect and can affect all manufacturing and supply chain activities.

Data quality is not isolated to IT organisations; it is a continuous process that must be nurtured in every organisation’s culture. Without a systematic way to start and keep data clean, bad data will happen. Furthermore, data quality in supply chain traceability systems depends on many variables. For example, how are the data entered into the system? What format(s) are they in? Does the system follow industry standards and procedures?

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Amit Sewak is the Vice President of Quality Management and Validation at rfxcel. He is an accomplished and driven quality leader with an outstanding record for developing and implementing quality assurance programmes. Amit established rfxcel’s global quality management programme and oversaw the creation of the Quality Support Team and organisational quality objectives. He is a champion for continuous process improvement and customer satisfaction. Amit has a BS in Biochemistry from San Francisco State University, US, and an MSc in Engineering Management from California State University, US.
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