Manufacturers subject to Good Manufacturing Practices (GMP) are required to document system modifications as well as operational changes that could affect electronic records. Audit trail reporting can be challenging in that information must be aggregated from multiple systems. In addition, there are tradeoffs between ensuring that all appropriate changes are reported in the audit trail while omitting records that are not relevant in order to make the review process manageable.
Informetric Audit Trail Reporting incorporates modules from InfoBatch™ batch reporting and, where necessary, AgileDoc® lifecycle management software to ensure that audit records reflect all events related to the electronic batch records. InfoBatch provides the batch context that is required to relate relevant audit records, while AgileDoc enables system design to be logically connected to manufacturing history.
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