Data integrity PIC S
good practices for data management and integrity in regulatory GMP/GDP environments
good practices for data management and integrity in regulatory GMP/GDP environments
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12.2.1.2 Evidence of open communication of issues with clients and other regulators.
Transparent communication should be maintained throughout the
investigation and remediation stages. Regulators should be aware that
further data integrity failures may be reported as a result of the detailed
investigation. Any additional reaction to these notifications should be
proportionate to public health risks, to encourage continued reporting;
12.2.1.3 Evidence of communication of data integrity expectations across the
organisation, incorporating and encouraging processes for open reporting of
potential issues and opportunities for improvement;
12.2.1.4 The regulated user should ensure that an appropriate evaluation of the
vulnerability of electronic systems to data manipulation takes place to ensure
that follow-up actions have fully resolved all the violations. For this evaluation
the services of qualified third party consultant with the relevant expertise may
be required;
12.2.1.5 Implementation of data integrity policies in line with the principles of this
guide;
12.2.1.6 Implementation of routine data verification practices.
13 Glossary
Archiving
Long term, permanent retention of completed data and relevant metadata in its final
form for the purposes of reconstruction of the process or activity.
Audit Trail
GMP/GDP audit trails are metadata that are a record of GMP/GDP critical information
(for example the creation, modification, or deletion of GMP/GDP relevant data), which
permit the reconstruction of GMP/GDP activities.
Back-up
A copy of current (editable) data, metadata and system configuration settings (e.g.
variable settings which relate to an analytical run) maintained for the purpose of
disaster recovery.
Computerised system
A system including the input of data, electronic processing and the output of
information to be used either for reporting or automatic control.
Data
Facts, figures and statistics collected together for reference or analysis.
Data Flow Map
A graphical representation of the "flow" of data through an information system
Data Governance
The sum total of arrangements to ensure that data, irrespective of the format in which
it is generated, recorded, processed, retained and used to ensure a complete,
consistent and accurate record throughout the data lifecycle.
PI 041-1 61 of 63 1 July 2021