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
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)
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.
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.
Traditional data integrity
verification solutions [3, 4], which are based on hash functions and digital signatures, are impractical to audit cloud data remotely due to their unacceptable communication and computational overhead to retrieve the outsourced files.