Data integrity PIC S

generation of working copies of documents for routine use, with specific
emphasis on ensuring copies of documents, e.g. SOPs and blank forms
are issued and reconciled for use in a controlled and traceable manner;
completion of paper based documents, specifying how individual
operators are identified, data entry formats, recording amendments, and
routine review for accuracy, authenticity and completeness; and
filing, retrieval, retention, archival and disposal of records.
8.2 Importance of controlling records
8.2.1 Records are critical to GMP/GDP operations and thus control is necessary to
ensure:
evidence of activities performed;
evidence of compliance with GMP/GDP requirements and company
policies, procedures and work instructions;
effectiveness of Pharmaceutical Quality System;
traceability;
process authenticity and consistency;
evidence of the good quality attributes of the medicinal products
manufactured;
in case of complaints or recalls, records could be used for investigational
purposes; and
in case of deviations or test failures, records are critical to completing an
effective investigation.
8.3 Generation, distribution and control of template records
8.3.1 Managing and controlling master documents is necessary to ensure that the
risk of someone inappropriately using and/or falsifying a record ‘by ordinary
means’ (i.e. not requiring the use of specialist fraud skills) is reduced to an
acceptable level. The following expectations should be implemented using a
quality risk management approach, considering the risk and criticality of data
recorded (see section 5.4, 5.5).
8.4 Expectations for the generation, distribution and control of records
Item Generation
1. Expectation
All documents should have a unique identifier (including the version number)
and should be checked, approved, signed and dated.
The use of uncontrolled documents should be prohibited by local procedures.
The use of temporary recording practices, e.g. scraps of paper should be
prohibited.
PI 041-1 21 of 63 1 July 2021