Audit Trail Manager

The Wonderware Factelligence® Audit Trail Manager module is intended for those companies seeking more granular auditing of modifications and changes to the Factelligence MES database. The Audit Trail Manager module was first created to facilitate FDA 21 CFR Part 11 compliance for our customer base. It has since been extended for use by all customers looking for advanced logging and audit reporting.

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A critical requirement of software systems for end user Part 11 compliance is their ability to generate an audit trail. An audit trail is defined as a record showing who has accessed the computer system and what operations that user has performed during a given period of time. An audit trail must satisfy the following criteria:

• It must be secure, computer generated and time stamped.
• It must not obscure previously changed data.
• It must indicate the person making the change.
• It must contain original and changed data.
• It must be available for review and copying by the FDA.

In terms of using the Audit Trail Manager module for enhancing logging or Part 11 regulatory compliance, Wonderware has several options available for our customer base. First, each relevant table within the Factelligence database can be set as "auditable" or not. The selection of which tables will be audited is part of implementation and is handled through a user interface created by Wonderware. Once the relevant tables have been selected, the customer determines whether or not inserts, updates or deletes to that table will be audited. Inserts being new records entered into the system, updates being changes made to the initial record and deletes representing a full deletion of the initial record. Upon conclusion of the configuration, all relevant transactions will have a relevant audit trail record that can be reported and viewed by the appropriate personnel. At the present time, Wonderware provides over ten (10) specific audit reports to assist with monitoring applicable changes to the system.

To request Wonderware Factelligence brochures or a demo CD, please see our downloads page.

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