Data integrity PIC S

where appropriate, or used as a “summary report” where the requirements of
a “true copy” are not met (e.g. summary of complex analytical data).
7.7.2 It is conceivable for raw data generated by electronic means to be retained
in an acceptable paper or pdf format, where it can be justified that a static
record maintains the integrity of the original data. However, the data retention
process should record all data, (including metadata) for all activities which
directly or indirectly impact on all aspects of the quality of medicinal products,
(e.g. for records of analysis this may include: raw data, metadata, relevant
audit trail and result files, software / system configuration settings specific to
each analytical run, and all data processing runs (including methods and
audit trails) necessary for reconstruction of a given raw data set). It would
also require a documented means to verify that the printed records were an
accurate representation. This approach is likely to be onerous in its
administration to enable a GMP/GDP compliant record.
7.7.3 Many electronic records are important to retain in their dynamic format, to
enable interaction with the data. Data should be retained in a dynamic form
where this is critical to its integrity or later verification. Risk management
principles should be utilised to support and justify whether and how long data
should be stored in a dynamic format.
7.7.4 At the receiving site, these records (true copies) may either be managed in a
paper or electronic format (e.g., PDF) and should be controlled according to
an approved QA procedure.
7.7.5 Care should be taken to ensure that documents are appropriately
authenticated as “true copies” in a manner that allows the authenticity of the
document to be readily verified, e.g. through the use of handwritten or
electronic signatures or generated following a validated process for creating
true copies.
Item How should the “true copy” be issued and controlled?
1. Creating a “true copy” of a paper document.
At the company who issues the true copy:
- Obtain the original of the document to be copied
- Photocopy the original document ensuring that no information from
the original copy is lost;
- Verify the authenticity of the copied document and sign and date the
new hardcopy as a “true copy”;
The “True Copy” may now be sent to the intended recipient.
Creating a “true copy” of a electronic document.
A ‘true copy’ of an electronic record should be created by electronic means
(electronic file copy), including all required metadata. Creating pdf versions
of electronic data should be prohibited, where there is the potential for loss
of metadata.
The “True Copy” may now be sent to the intended recipient.
A distribution list of all issued “true copies” (soft/hard) should be maintained.
PI 041-1 18 of 63 1 July 2021