February 25th, 2021 | 33:36

Understanding the 2021 Regulatory Expectation for Data & Metadata Integrity

Data integrity means complete, consistent, and accurate recording of data. Data integrity is critical throughout current good manufacturing practice (cGMP) to ensure product quality. Evidenced by increased regulatory citations for inadequate data integrity, regulatory bodies like the FDA, have increased their expectations for the quality, compliance and integrity of data (including metadata) providing detailed instructions to the industry in their Final Guidance on Data Integrity and Compliance in December 2018.

Driven by digital transformation with highly sophisticated data systems, storage of data in the cloud, the internet highway; the implementation of good data practices and necessary controls are needed now. Companies not prepared could stumble leading to regulatory actions.

In this webinar, we’ll discuss FDA, WHO and the UK MHRA and the harmonization of these guidances and include:
Brief explanation of definitions (such as metadata)

  • Examples of stumbling blocks that could lead to regulatory actions
  • Practical illustrations to better understand guidances and regulatory requirements
  • Controls and security that need to be in place
  • Data Validation and Retention/Archive

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