Emerson Exchange 365

Review by exception (RBE) of electronic batch records is becoming a powerful tool for life sciences companies.  Here’s a partial list of exceptions that we developed for a project a few years back and that should be included with any review by exception report.  By no means is this a complete list.  In order to truly meet the requirements for lot acceptance I’d recommend starting at the end with the criteria needed for lot release and then working backwards during system design to ensure that elements needed for review by exception are considered from the beginning.  The list is relatively system agnostic and ultimately any review by exception system is a reporting tool.

1. Use of equipment that does not meet ready for use requirements
2. Use of raw materials or consumables that are not approved for use or have expired
3. Use of raw materials or consumables that are not specified for the process being executed
4. Critical Process Parameters that exceed designated criteria
5. Material charging exceeds limits
6. Use of Work-In-Process materials, such as media and buffers, that have expired or have exceeded acceptable process parameters
7. Filter integrity failures for Virus Filter and Final Product filters
8. Equipment or instrument malfunction or failure during process execution
9. Automated integration malfunction or failure and manual entries / manipulations required as a result of the failure
10. Forced or voided work instructions during batch record execution
11. Step changes in the process automation system (Delta V)
12. OOS Sample results
13. Deviation from any manual operational steps
14. Communication failures with third party systems such as ERP, CMMS, LIMS
15. Work instructions steps that have been annotated with operator comments
16. Aborted batches

 For more information on exception reports check out Exception Reports in Life Science paper.  It provides an in-depth look at exception reports in Life Science’s.  Got some more ideas that should be included in the list please post them.