Signature/Record Linking - 11​.70

21 CFR Part 11:

“Electronic signatures and handwritten signatures executed to electronic records shall be linked to their respective electronic records to ensure that the signatures cannot be excised, copied, or otherwise transferred to falsify an electronic record by ordinary means.”

The following tables contain user information for either “Done by” or “Check by” signature. The user information is associated to the individual records (see Table 2 for detailed column information).

• AuditEvent

• BatchAdmin

• BatchDetail

• ProcessVarChange

• MaterialInputChange

• OperatorComment

• BatchQuestion

• EquipStatus

• DocViewEvent

For example, Figure 33 depicts records from the AuditEvent table containing the user id for either “Check By” or “Done By" signature. The AVEVA Batch Management interface does not provide any way to manipulate the signature associated with a record once they are entered.

Furthermore, once a user signs in an AVEVA Batch Management user interface, the signature popup is closed and a subsequent user has no way to copy the previous user password in order to falsify a signature.

The BatchHistory database tables are not accessible to the AVEVA Batch Management regular users but can be accessed through SQL Server management studio. In order to prevent someone to change the content of a record, the BatchHistory and BatchArchive database users shall be strictly controlled.

The event records are maintained in a SQL Server relational database. If, despite the security setup around the servers and database, the risk of having a user accessing the database to manipulate the records is considered significant, an MS SQL Audit trail should be setup by the database administrator.