Data integrity PIC S

6.5 Regular management review of performance indicators (including quality
metrics)
6.5.1 There should be regular management reviews of performance indicators,
including those related to data integrity, such that significant issues are
identified, escalated and addressed in a timely manner. Caution should be
taken when key performance indicators are selected so as not to
inadvertently result in a culture in which data integrity is lower in priority.
6.5.2 The head of the Quality unit should have direct access to senior management
in order to directly communicate risks so that senior management is aware
and can allocate resources to address any issues.
6.5.3 Management can have an independent expert periodically verify the
effectiveness of their systems and controls.
6.6 Resource allocation
6.6.1 Management should allocate appropriate resources to support and sustain
good data integrity management such that the workload and pressures on
those responsible for data generation and record keeping do not increase the
likelihood of errors or the opportunity to deliberately compromise data
integrity.
6.6.2 There should be sufficient number of personnel for quality and management
oversight, IT support, conduct of investigations, and management of training
programs that are commensurate with the operations of the organisation.
6.6.3 There should be provisions to purchase equipment, software and hardware
that are appropriate for their needs, based on the criticality of the data in
question. Companies should implement technical solutions that improve
compliance with ALCOA+ 5 principles and thus mitigate weaknesses in
relation to data quality and integrity.
6.6.4 Personnel should be qualified and trained for their specific duties, with
appropriate segregation of duties, including the importance of good
documentation practices (GdocPs). There should be evidence of the
effectiveness of training on critical procedures, such as electronic data
review. The concept of good data management practices applies to all
functional departments that play a role in GMP/GDP, including areas such as
IT and engineering.
6.6.5 Data quality and integrity should be familiar to all, but data quality experts
from various levels (SMEs, supervisors, team leaders) may be called upon to
work together to conduct/support investigations, identify system gaps and
drive implementation of improvements.
6.6.6 Introduction of new roles in an organisation relating to good data
management such as a data custodian might be considered.
5 EMA guidance for GCP inspections conducted in the context of the Centralised Procedure
PI 041-1 14 of 63 1 July 2021