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Maintaining Data Integrity in GMP Environments

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.

  • Data and its attributes

  • What is considered data

  • What does ALCOA and ALCOA+ stand for and how does it apply to data integrity principles

  • Understanding common terms around data: meta data, audit trails, true copies, electronic records and electronic signatures

  • Inputs from USFDA on data integrity related queries and doubts.

  • Consequences of data integrity non-compliance

  • Common data integrity failures, and the reason for such failures

  • Prevention of data integrity failures

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

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.

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