A database which captures, tracks, sorts, and reports audit requests is of immense value to any audit management team. Audit Utopia ™ is web-based, real-time inspection management software which accomplishes all of the above, and is 21 CFR Part 11 compliant. As a request is made, it is entered into a field and automatically date stamped, numbered, and identified by inspector. The support room is notified of a new request by an audible tone, and is able to immediate begin the process of preparing the document, and notifying the presenter of the request. The screen with all of the details of the request is then printed in the support room and attached to the document, thus providing an immediate summary of all of the critical request information as a cover sheet on the document.
Throughout the inspection, the audit team will use Audit Utopia ™ to automatically sort the requests, and set the agenda. An immediate overview of the number of open/closed requests allows for precise scheduling. At the end of each inspection day, the audit manager is immediately prepared to present to the company audit team the details of the days’ activities, and the plans for the next day. Instead of discussing “what happened” or “what was requested and why”, the team focuses on who, how, and when to present the key data.
“Successful FDA inspections are dependent on having a combination of seasoned individuals responsible for hosting, note-taking, and ‘running’ requests back and forth from the conference room. This software tool has been tested during my simulated FDA mock inspections and it serves to overall stream-line the inspection process. As a former FDA investigator, I fully endorse this software tool and recommend it to any company working in a regulated industry. It will impress any FDA investigator that comes to your facility for an inspection. Successfully managing FDA inspections is the bottom line!”
Jeff Yuen, MPH, MBA, Former Commander, FDA
Audit Utopia ™ will provide one single platform for a well-organized audit whether it’s a regulatory, customer, or internal inspection. Not only does Audit Utopia ™ manage, track, sort, and report audit requests instantly, but it streamlines communication between your inspection team in other ways. Audit Utopia ™ will automatically create an inspection team chat room for the audit intended as a temporary log of informal communication easily between team members. Private peer-to-peer chat and file transfer is also an available function within the system. Last, but not least, the robust scribe function allows simultaneous transcription of multiple inspectors conversations. More importantly, the scribe feature provides a real-time capture of the record of the inspection.
Audit Utopia TM was found to successfully:
- Reduce request entry and tracking cycle time by 83%
- Reduce observations per inspection day by 38%
- Reduce FDA 483 observations by 82%
In the end, the auditor is impressed with the speed of document retrieval, the effective control of the Quality leaders, and the overall positive, thoughtful and respectful responses of the firm. If the firm can demonstrate complete competency in this area, the auditor knows the firm’s Quality unit is in control and well managed.