Data integrity PIC S

Data Integrity
The degree to which data are complete, consistent, accurate, trustworthy, reliable and
that these characteristics of the data are maintained throughout the data life cycle.
The data should be collected and maintained in a secure manner, so that they are
attributable, legible, contemporaneously recorded, original (or a true copy) and
accurate. Assuring data integrity requires appropriate quality and risk management
systems, including adherence to sound scientific principles and good documentation
practices. The data should comply with ALCOA+ principles.
Data Lifecycle
All phases in the life of the data (including raw data) from initial generation and
recording through processing (including transformation or migration), use, data
retention, archive / retrieval and destruction.
Data Quality
The assurance that data produced is exactly what was intended to be produced and fit
for its intended purpose. This incorporates ALCOA + principles. 14
Data Ownership
The allocation of responsibilities for control of data to a specific process owner.
Companies should implement systems to ensure that responsibilities for systems and
their data are appropriately allocated and responsibilities undertaken.
Dynamic Record
Records, such as electronic records, that allow an interactive relationship between the
user and the record content. 13
Exception Report
A validated search tool that identifies and documents predetermined ‘abnormal’ data
or actions, which require further attention or investigation by the data reviewer.
Good Documentation Practices (GdocP)
Those measures that collectively and individually ensure documentation, whether
paper or electronic, meet data management and integrity principles, e.g. ALCOA+.
Hybrid Systems
A system for the management and control of data that typically consists of an electronic
system generating electronic data, supplemented by a defined manual system that
typically generate a paper-based record. The complete data set from a hybrid system
therefore consists of both electronic and paper data together. Hybrid systems rely on
the effective management of both sub-systems for correct operation.
Master Document
An original approved document from which controlled copies for distribution or use can
be made.
14 ‘GXP’ Data Integrity Guidance and Definitions, MHRA, March 2018
PI 041-1 62 of 63 1 July 2021