Data Audit Trail & Electronic Batch Record (EBR)

Wayahead have developed a validated data audit trail, to regulatory level, which manages all database changes, to all fields, in all tables. Each record change, is recorded to identify the date, time, user, workstation, program and the before & after data values.

Throughout 3WS, many processes require the user to complete their Electronic Signature (eSignature), to record who they are and whether they are authorised to complete an activity. The eSignature process includes all 21CFR11 requirements. As each user is recorded against every activity, though-out the production cycle, an excellent history is maintained for each site.

All interfaces between 3WS and other systems, generate a detailed audit trail to explain exactly which data was processed on each system.

The data audit trail and eSignature features, addresses all the requirements of 21CFR11, to deliver a full EBR for an work order processed through 3WS.

Display of a Data Audit Trail update screen, against work order item (BATCHITM) record.

Auditing update

Audit report