Data integrity (DI) is an essential element in ensuring the reliability of data and information obtained and managed in biomanufacturing. The number of observations made regarding the integrity of data during inspections of good manufacturing practice (GMP) has been increasing, clearly signalling a need for companies to better understand the requirements and ensure confidence in their compliance. In 2016, the BPIT compliance SMEs collaborated to co-author an industry response to the IT data integrity guidelines provided by regulators to support companies in understanding the requirements and in ensuring clarity in their approach to compliance. Furthermore, the guidance in the response paper and the companion template, “Universal Data Integrity System Assessment Template in the Biopharmaceutical Industry”, supports companies by providing a shared view of which controls to implement within a company and offers best practices to manage risks. This results in a common response to regulators and achieves increased confidence in a company’s approach to compliance. The guidance outlines the controls required generally and those required specifically for three categories of IT systems in biomanufacturing – enterprise applications, local systems and equipment.
Data integrity (DI) for IT in the biopharmaceutical industry
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