Data integrity PIC S

8.9 Direct print-outs from electronic systems
8.9.1 Some very simple electronic systems, e.g. balances, pH meters or simple
processing equipment which do not store data, generate directly-printed
paper records. These types of systems and records provide limited
opportunity to influence the presentation of data by (re-)processing, changing
of electronic date/time stamps. In these circumstances, the original record
should be signed and dated by the person generating the record and
information to ensure traceability, such as sample ID, batch number, etc.
should be recorded on the record. These original records should be attached
to batch processing or testing records.
8.9.2 Consideration should be given to ensuring these records are enduring (see
section 8.6.1).
8.10 Document retention (Identifying record retention requirements and archiving
records)
8.10.1 The retention period of each type of records should (at a minimum) meet
those periods specified by GMP/GDP requirements. Consideration should be
given to other local or national legislation that may stipulate longer storage
periods.
8.10.2 The records can be retained internally or by using an outside storage service
subject to quality agreements. In this case, the data centre’s locations should
be identified. A risk assessment should be available to demonstrate retention
systems/facilities/services are suitable and that the residual risks are
understood.
Item Where and how should records be archived?
1. Expectation
A system should be in place describing the different steps for archiving
records (identification of archive boxes, list of records by box, retention
period, archiving location, etc.).
Instructions regarding the controls for storage, as well as access and
recovery of records should be in place.
Systems should ensure that all GMP/GDP relevant records are stored for
periods that meet GMP/GDP requirements 9 .
Specific elements that should be checked when reviewing records:
Check that the system implemented for retrieving archived records is
effective and traceable.
Check if the records are stored in an orderly manner and are easily
identifiable.
Check that records are in the defined location and appropriately
secured.
9 Note that storage periods for some documents may be dictated by other local or national legislation.
PI 041-1 29 of 63 1 July 2021