Data Without Integrity Is Just Numbers: Data Integrity & Records

Course "Data Without Integrity Is Just Numbers: Data Integrity & Records" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
Overview:
The impact of Data Integrity issues on a regulated company can be significant: it can result in recalls of products, warning or untitled letters, import alerts, injunctions, seizures, legal action, etc. These regulatory actions can have significant financial impact to the company. However, and most importantly, Data Integrity issues can lead to potential patient harm!!
Defined by the Medicines and Healthcare Products Regulatory Agency (MHRA) as "the extent which all data are complete, consistent and accurate throughout the data lifecycle", Data Integrity is increasingly the focus of regulatory agencies round the world. Companies must now ensure that they are appropriately addressing Data Integrity and data integrity. This includes organizational, procedural and technical controls that must be considered as part of an overarching data integrity system. In addition, the effort and resources committed to Data Integrity must be commensurate with the role it plays in assuring product quality.
To ensure Data Integrity, a GxP regulated company needs to abide by principles, current regulations and industry best practices on the expectations for the management GxP regulated records and data. These principles, regulations and best practices, ensure that data is complete, consistent, accurate, secure and available throughout the record life cycle. This approach is intended to encourage innovation and technological advances while avoiding unacceptable risk to product quality, patient safety and public health.