Maintaining Accurate System Configuration Information
In environments where strict tracing records are kept, such as manufacturing of pharmaceuticals, you should maintain detailed and dated records of control program settings, routing registration records, and BOM registration records. These records are important for product recall and for quality assurance.
You should also set up procedures like the following to help you record and regulate any changes to these WLT control settings.
• Consider defining designated roles with permissions to WLT control programs.
• Maintain an external system where you can record any control changes. This might be a simple spreadsheet, or an automated data-mining utility that records any control changes automatically.
• Avoid making manual changes to routing or BOM registrations. Instead, you should use the registration start and end dates to manage changes.
Example: When lot/serial number formats change, create a WLT routing registration with the new NRM ID. Set the effective date for the new registration to a date immediately following the effective end date of the registration being changed. When a change needs to be expedited, change the effective end date of the registration being changed to correspond with the new registration’s start effective date.
In addition to control records, you should also create, maintain, and adhere to a delete/archive schedule for all WLT historical information. Set up procedures that let you maintain correct and accurate historical tracing records that have been deleted from your system and archived elsewhere. Consider setting up procedures that let you easily locate and extract tracing records from archived tracing records.