Data integrity PIC S

- clear means of differentiating approved copies of documents, e.g. by use
of a secure stamp, or paper colour code not available in the working areas
or another appropriate system;
- ensuring that only the current approved version is available for use;
- allocating a unique identifier to each blank document issued and recording
the issue of each document in a register;
- numbering every distributed copy (e.g.: copy 2 of 2) and sequential
numbering of issued pages in bound books;
- where the re-issue of additional copies of the blank template is necessary,
a controlled process regarding re-issue should be followed with all
distributed copies maintained and a justification and approval for the need
of an extra copy recorded, e.g.: “the original template record was
damaged”;
- critical GMP/GDP blank forms (e.g.: worksheets, laboratory notebooks,
batch records, control records) should be reconciled following use to
ensure the accuracy and completeness of records; and
- where copies of documents other than records, (e.g. procedures), are
printed for reference only, reconciliation may not be required, providing the
documents are time-stamped on generation, and their short-term validity
marked on the document.
Potential risk of not meeting expectations/items to be checked
Without the use of security measures, there is a risk that rewriting or
falsification of data may be made after photocopying or scanning the
template record (which gives the user another template copy to use).
Obsolete versions can be used intentionally or by error.
A filled record with an anomalous data entry could be replaced by a
new rewritten template.
All unused forms should be accounted for, and either defaced and
destroyed, or returned for secure filing.
Check that (where used) reference copies of documents are clearly
marked with the date of generation, period of validity and clear
indication that they are for reference only and not an official copy, e.g.
marked ‘uncontrolled when printed.
8.4.1 An index of all authorised master documents, (SOP’s, forms, templates and
records) should be maintained within the Pharmaceutical Quality System.
This index should mention for each type of template record at least the
following information: title, identifier including version number, location (e.g.
documentation database, effective date, next review date, etc.).
8.5 Use and control of records located at the point-of-use
8.5.1 Records should be available to operators at the point-of-use and appropriate
controls should be in place to manage these records. These controls should
be carried out to minimize the risk of damage or loss of the records and
ensure data integrity. Where necessary, measures should be taken to protect
records from being soiled (e.g. getting wet or stained by materials, etc.).
PI 041-1 24 of 63 1 July 2021