This eLearning module reviews the importance of data integrity in drug manufacturing, common failures in data integrity, and the necessary steps that must be taken to ensure integrity of the data generated at pharmaceutical organizations.
|Who is it for||
Data integrity is relevant to all employees in drug product and drug substance manufacturing, quality assurance and quality control, management, supply chain, accounts, finance, and IT.
|Why it matters||
Consumers expect, the drugs they consume to be safe and effective. Quality and effectiveness of a drug can only be assured if the manufacturing, testing, storage and distribution that the drugs have been done as per regulations. Data recorded and maintained by pharmaceutical organizations is the only means which can provide evidence that regulations were followed. Therefore, data integrity is the bedrock of GMP environments and is key to regulators’ ability to protect public health