| 2 |
The system produces exact, complete and readable copies of
all records (acquired data, audit trail, electronic signatures, etc.)
in electronic format or paper format throughout the retention
period. |
11.10 (b) |
| 3 |
Electronic records can be retrieved in full throughout the
retention period. |
11.10 (c) |
| 4 |
The system produces an audit trail automatically. |
11.10 (e) |
| 5 |
The system maintains all audit trails |
11.10 (e) |
| 6 |
The audit trail is easy to use and work with. |
11.10 (e) |
| 7 |
For records which are critical according to regulations, the
following operations are specified in the audit trail :
- creation
- revision
- deletion
|
11.10 (e) |
| 8 |
The audit trail contains:
- exact time and date of the action
- nature of the operation
- name of the operator who performed the operation (for
GLP/GMP, the reason for the modification must be
provided but not necessarily in this audit trail).
|
11.10 (e) |
| 9 |
In case of revision or deletion, the audit trail will maintain the old
and new data. |
11.10 (e) |
| 10 |
The audit trail is kept for as long as the record to which it is
associated. |
11.10 (e) |
| 11 |
The system is built such that the sequence of
possible/impossible operations matches exactly with the
execution of the actual physical tasks. |
11.10 (f) |
| 12 |
During each work session, the user name will appear clearly on
each screen/page |
|
| 13 |
All electronic signatures (appearing on the screen, as well as on
printouts) clearly identify the name of the signatory, the date
and time of the signature as well as the meaning of the
signature. |
11.50 |
| 14 |
The meaning or reason for signing are:
|
11.50 |
| 15 |
An electronic signature is linked to the electronic record to
which it pertains
|
11.70 |
| 16 |
The link between the electronic signature and the electronic
record cannot be broken
|
11.70 |
| 17 |
An electronic signature which is associated with an electronic
record cannot be transferred to another electronic record by any
means or by anyone.
|
11.70 |
| 18 |
The electronic signature contains at least 2 elements:
|
11.200 (a) |
| 19 |
When the signatures are not executed during a continuous
session, the two elements for the signatures are executed if one
wants to execute an electronic signature.
|
11.200 (a) |
| 20 |
If a user leaves his work area during the session, the system
interrupts the work after a pre-determined amount of time.
|
|
| 21 |
In case of system interruption during a session, the user must
log in again to re-start the session.
|
|
