K2C Audit Trail for SharePoint enables the full compliance to requirements of 21 CFR part 11 in USA, Annex 11 in Europe and many other regulations. A powerful audit trail solution allows a high control on data changes and therefore prevents a series of business risks and not just deviations to compliance standards.
The sole use of SharePoint audit trail features ensure only in theory a full compliance with regulation requirements: we can try considering a combined used of other native features, such as versioning, record declaration, security etc.: but it is very difficult and sometime impossible, especially when configuring SharePoint to implement complex processes or business cases.
K2C Audit Trail is many more powerful than SharePoint native feature, it is fully automated but also configurable in order to limit the monitoring activity to some selected lists or libraries, therefore avoiding an excessive growth of system databases.
All audit trail data are safely saved into an external database, not in SharePoint: nonetheless you can browse audit trail data from SharePoint, simply adding the K2C Audit Trail View web part to a SharePoint site page.
Main features of K2C Audit Trail:
Selection of lists or libraries to be under audit trail: this allows to limit audit trail to critical data only
Trace of end-user operation: item added, updated, deleted, checked in, checked out
Automated recording of changed values, author of change and timestamp
Automated recording of changes in metadata structure (list column added or deleted)
Automated recording of audit trail configuration changes
Views (web part) to monitor audit trail data from SharePoint, with filters and option to export data in excel
Magamenent of audit trail data in external database, safely distinct from SharePoint content databases
K2C Audit Triail and other solutions included in K2C Compliance Suite for SharePoint can be used all together to comply with a variety of current regulations, including the US CFR21 part 11 and European Annex 11. Read our free White Paper for SharePoint compliance with 21 CFR part 11.