FDA: Data Integrity and Compliance With Drug CGMP, December 2018
According to the FDA, data integrity refers to the completeness, consistency, and accuracy of data. Data should be attributable, legible, contemporaneously recorded, either original or true copy, and accurate as well as complete, consistent, enduring and available (ALCOA+).
By design, iStudyReporter is addressing these requirements of the guidances.
End-to-end data integrity is a build-in feature of iStudyReporter by having
- validated interfaces to Watson and other LIMS systems (Remote Collector),
- the table sections in the created documents protected
- created documents being transferred to eCTD systems using native interfaces