Data integrity PIC S

Quality monitoring
Quality and performance monitoring may indicate incentive
for data falsification (e.g. raw materials which marginally
comply with specification on a frequent basis.
10.3.5 Contract givers may work with the contract acceptor to ensure that all clientconfidential
information is encoded to de-identify clients. This would facilitate
review of source electronic data and metadata at the contract giver’s site,
without breaking confidentiality obligations to other clients. By reviewing a
larger data set, this enables a more robust assessment of the contract
acceptors data governance measures. It also permits a search for indicators
of data integrity failure, such as repeated data sets or data which does not
demonstrate the expected variability.
10.3.6 Care should be taken to ensure the authenticity and accuracy of supplied
documentation (refer section 8.11). The difference in data integrity and
traceability risks between ‘true copy’ and ‘summary report’ data should be
considered when making contractor and supply chain qualification decisions.
11 REGULATORY ACTIONS IN RESPONSE TO DATA INTEGRITY
FINDINGS
11.1 Deficiency references
11.1.1 The integrity of data is fundamental to good manufacturing practice and the
requirements for good data management are embedded in the current PIC/S
Guides to GMP/GDP for Medicinal products. The following table provides a
reference point highlighting some of these existing requirements.
ALCOA principle
Attributable
PIC/S Guide
to Good
Manufacturing
Practice for
Medicinal
products,
PE 009
(Part I):
[4.20, c & f],
[4.21, c & i],
[4.29 point 5]
Legible [4.1], [4.2],
[4.7], [4.8],
[4.9], [4.10]
PIC/S Guide
to Good
Manufacturing
Practice for
Medicinal
products,
PE 009
(Part II):
[5.43], [6.14],
[6.18], [6.52]
[6.11], [6.14],
[6.15], [6.50]
Annex 11
(Computerised
Systems)
[2], [12.1],
[12.4], [15]
[4.8], [7.1], [7.2]
[8.1], [9], [10],
[17]
PIC/S
Guide to
Good
Distribution
Practice for
Medicinal
products,
PE 011:
[4.2.4],
[4.2.5]
[4.2.3],
[4.2.9]
Contemporaneous [4.8] [6.14] [12.4], [14] [4.1], [4.2.9]
Original [4.9], [4.27],
[Paragraph
"Record"]
[6.14], [6.15],
[6.16]
[8.2], [9] [4.2.5]
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