Manufacturers must not only achieve compliance but must have the evidence of doing so readily available at any time.
Take control of your data
Wayahead have developed a validated data audit trail to regulatory levels, which manages all database changes, to all fields, in all tables. It allows users to collect, store, retrieve, display and analyse all process data. Each record change is recorded to identify the date, time, user, workstation, program and the before & after data values.
The audit trail retains a complete log of all database changes, including any external program access. A copy and enquiry facility is available for local and offsite, i.e. regulatory reviews.
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, throughout the production cycle, an excellent history is maintained for each site.
All automatic interfaces between 3WS and other systems, such as ERP applications or PLC equipment, generate a detailed interface audit trail to explain exactly which data was processed on each system. The data audit trail and eSignature features address all the requirements of regulatory compliance to deliver a full EBR for any work order processed through 3WS.