Data integrity PIC S

6.2.2 Management should make personnel aware of the importance of their role in
ensuring data quality and the implication of their activities to assuring product
quality and protecting patient safety.
6.2.3 Policies should clearly define the expectation of ethical behaviour, such as
honesty. This should be communicated to and be well understood by all
personnel. The communication should not be limited only to knowing the
requirements, but also why they were established and the consequences of
failing to fulfil the requirements.
6.2.4 Unwanted behaviours, such as deliberate data falsification, unauthorised
changes, destruction of data, or other conduct that compromises data quality
should be addressed promptly. Examples of unwanted behaviours and
attitudes should be documented in the company policies. Actions to be taken
in response to unwanted behaviours should be documented. However, care
should be taken to ensure that actions taken, (such as disciplinary actions)
do not impede any subsequent investigation into the data integrity issues
identified, e.g. severe retribution may prevent other staff members from
disclosing information of value to the investigation.
6.2.5 The display of behaviours that conform to good practices for data
management and integrity should be actively encouraged and recognised
appropriately.
6.2.6 There should be a confidential escalation program supported by company
policies and procedures whereby it encourages personnel to bring instances
of possible breaches of policies to the attention of senior management
without consequence for the informer/employee. The potential for breaches
of the policies by senior management should be recognised and a suitable
reporting mechanism for those cases should be available.
6.2.7 Where possible, management should implement systems with controls that
by default, uphold the intent and requirements of company policies.
6.3 Quality culture
6.3.1 Management should aim to create a work environment (i.e. quality culture)
that is transparent and open, one in which personnel are encouraged to freely
communicate failures and mistakes, including potential data reliability issues,
so that corrective and preventive actions can be taken. Organisational
reporting structure should permit the information flow between personnel at
all levels.
6.3.2 It is the collection of values, beliefs, thinking, and behaviours demonstrated
consistently by management, team leaders, quality personnel and all
personnel that contribute to creating a quality culture to assure data quality
and integrity.
6.3.3 Management can foster quality culture by:
Ensuring awareness and understanding of expectations (e.g. Code of
Values and Ethics and Code of Conduct),
Leading by example, management should demonstrate the behaviours
they expect to see,
Being accountable for actions and decisions, particularly delegated
activities,
PI 041-1 12 of 63 1 July 2021