Specifications

57
Validation locking and
electronic signatures
After completion of a checkpoint,
an entire component or a full vali-
dation, the validation can be
locked partially or completely. To
avoid locking of incomplete items,
the application software will dis-
play a warning message and close
the lock dialog without changes if
the locking item is not complete.
Partial validation locking allows
locking a single checkpoint or a
complete component. After lock-
ing the item, no changes are possi-
ble to this particular item. It is in a
review-only mode allowing only
printing reports and reviewing the
graphics. Every locking action
automatically creates a new revi-
sion of the validation in the DMS
system. Only users with an access
level 3 (planning) or higher have
access to the locking functionality.
Each locking action requires an
electronic signature. The electron-
ic signature uses the password/
user ID combination as defined by
the FDA (figure 44). The sign-off
dialog comes with a time limit of
45 seconds. If the signature was
not executed during this period,
the dialog will close and the vali-
dation status remains unchanged.
Figure 44
Executing electronic signatures with Method Validation Pack