Designed with the healthcare industry in mind, the US FDA 21 CFR Part 11 regulations outline criteria for accepting electronic records and electronic signatures as equivalent to paper-based records and handwritten signatures. FDA 21 CFR Part 11 also provides guidelines for documenting and validating authorized change processes to systems and software involved in the creation of electronic documents. Tripwire solutions enable IT groups to close the loop in their IT change management processes.

An Ironclad Defense: Detective Control

Tripwire provides what auditors call a detective control. It delivers the hard evidence of IT configuration audit and control that auditors want. Tripwire gives you:

• Automated configuration control that isn't susceptible to human error or lapses in judgment
• Broad infrastructure coverage of changes on servers, workstations and network devices, including changes made both manually or by automated tools
• Independent evidence of change through perfect segregation of duties - the person or tool that made the change is not used to validate the change