Data Integrity - two new documents from PIC/S and EMA
PIC/S 041-1 "Good Practices for Data Management and Integrity
in regulated GMP/GDP environments"
The current PIC/S draft document PI 041-1 contains 41 pages of
detailed information. The document was written to provide guidance for
inspectorates. The comment period for PIC/S Participating Authorities will end
on 28 February 2017. The following activities have not been defined yet.
The introduction referred to the fact that the effectiveness of
inspection processes is determined by the veracity of the evidence provided to
the inspector and ultimately the integrity of the underlying data. Furthermore
it is critical to the inspection process that inspectors can determine and,
fully rely on the accuracy and completeness of evidence and records presented
to them. Therefore Good Data Management practices influence the integrity of
all data generated and recorded by a manufacturer and these practices should
ensure that data is accurate, complete and reliable.
The first third of the document introduces 3 basic
principles:
- Data
governance system
- Organisational
influences on successful data integrity management
- General
data integrity principles and enablers
The main part of the document focuses on the topics "Specific
DI considerations for paper-based systems" and "Specific data
integrity considerations for computerised systems". Here you can find the
expectations of inspectors for different items. Each item will discussed in
relation to "potential risk of not meeting expectations / items to be
checked".
At the end of the document you will find 4 additional chapters on
- Data
integrity considerations for outsourced activities
- Regulatory
actions in response to data integrity findings
- Remediation
of data integrity failures
- Definitions
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