Data integrity PIC S

7.8.3 It is therefore essential that summary reports are viewed as but one element
of the process for the transfer of data and that interested parties and
Inspectorates do not place sole reliance on summary report data.
7.8.4 Prior to acceptance of summary data, an evaluation of the supplier’s quality
system and compliance with data integrity principles should be established.
It is not normally acceptable nor possible to determine compliance with data
integrity principles through the use of a desk-top or similar assessment.
7.8.4.1 For external entities, this should be determined through on-site audit when
considered important in the context of quality risk management. The audit
should assure the veracity of data generated by the company, and include a
review of the mechanisms used to generate and distribute summary data and
reports.
7.8.4.2 Where summary data is distributed between different sites of the same
organisation, the evaluation of the supplying site’s compliance may be
determined through alternative means (e.g. evidence of compliance with
corporate procedures, internal audit reports, etc.).
7.8.5 Summary data should be prepared in accordance with agreed procedures
and reviewed and approved by authorised staff at the original site.
Summaries should be accompanied with a declaration signed by the
Authorised Person stating the authenticity and accuracy of the summary. The
arrangements for the generation, transfer and verification of summary reports
should be addressed within quality/technical agreements.
8 SPECIFIC DATA INTEGRITY CONSIDERATIONS FOR PAPER-
BASED SYSTEMS
8.1 Structure of Pharmaceutical Quality System and control of blank
forms/templates/records
8.1.1 The effective management of paper based documents is a key element of
GMP/GDP. Accordingly the documentation system should be designed to
meet GMP/GDP requirements and ensure that documents and records are
effectively controlled to maintain their integrity.
8.1.2 Paper records should be controlled and should remain attributable, legible,
contemporaneous, original and accurate, complete, consistent enduring
(indelible/durable), and available (ALCOA+) throughout the data lifecycle.
8.1.3 Procedures outlining good documentation practices and arrangements for
document control should be available within the Pharmaceutical Quality
System. These procedures should specify how data integrity is maintained
throughout the lifecycle of the data, including:
creation, review, and approval of master documents and procedures;
generation, distribution and control of templates used to record data
(master, logs, etc.);
retrieval and disaster recovery processes regarding records;
PI 041-1 20 of 63 1 July 2021