Food and Drug Administration posted a warning letter to Ningbo Huize Commodity Co., an over-the-counter (OTC) drug manufacturer, for significant current good manufacturing practice (CGMP) violations, including
data integrity issues.
While FDA expects all data to be reliable and accurate, the introduction of the final guidance emphasizes that firms should "implement meaningful and effective strategies to manage their
data integrity risks based on their process understanding and knowledge management of technologies and business models." For more information on risk assessment and analysis, see Contract Pharma's September 2017 feature, "
Data Integrity: A Practical and Risk-Based Approach." (3)
Data integrity among GMP manufacturers (reason one)
Validity is a provider of
data integrity and compliance offerings that tens of thousands of organisations worldwide rely on to trust their data.
The FDA uses the acronym ALCOA to define
data integrity, meaning, it is attributable (who did it/source data), legible (recorded in a permanent medium and it is readable), contemporaneous (data recorded in real time), original (an original or certified true copy of data), and accurate (no errors or editing performed without documented amendments).
'With Oracle Enterprise Data Management Cloud, we are providing a modern platform that streamlines business transformation efforts and enables organizations to maintain
data integrity, accuracy and consistency across all their applications in the cloud and on-premises.' Oracle Enterprise Data Management Cloud can provide benefits like faster cloud adoption, enhanced business agility, better alignment of enterprise applications and system of reference for all the enterprise data.
With an LIS, the strength of the underlying database is a fundamental element of
data integrity. For example, use of foreign key integrity constraints will prevent orphaned data from entering into the database tables.
Data integrity of Police department was recorded to be 99 percent while percentage of complaints was 14 percent.
Land Record Management System's 11% complaints were received while
data integrity remained 74%; and Domicile Service's
data integrity remained 98% while 3% complaints were received.
London, United Kingdom, October 27, 2017 --(PR.com)-- Many people within the pharmaceutical industry are confused by the concept of
data integrity?
Data integrity is comprised of these following broad actions to hide test failures and/or manufacturing deviations:
Regulatory agencies have begun to recognize the
data integrity challenges and issues.