During 2011-2012, Genentech used a cloud-based process to manage 3 FDA GCP sponsor inspections. Cloud-based applications such as gDoc and gChat were used to track inspection requests, global team availability and capture lessons learnt in real time.
This poster is aimed to provide an overview of an innovative cloud-based approach successfully used to manage multiple GCP sponsor inspections resulting in time savings, efficient use of resources, streamlined communication and reduced paperwork.
"Before the start of an inspection, gDoc was created with restricted edit/view access for prep room and inspection room staff. This gDoc would capture details of requests including request #, date/time of request, request assignment, and request completion date/time. Requests from the inspector were captured using the gDoc in the inspection room, which would be visible in real time in the prep room. The prep room leader could use gChat to request clarification on a request if needed. When compared to a paper-based inspection request process, this model accounted for significant time savings. For example, if 100 inspection requests were made, an average saving of 5-10 minutes per request would translate to 8-16 hours or 1-2 working days of time lost in transit (i.e., writing the request and physically delivering it to the prep room). This model also allowed the prep room staff to focus on document QC and interview prep. The number of runners were decreased from 3-4 to 1-2, primarily to deliver completed requests to the inspection room. When compared to other electronic inspection request processes such as emailing requests to the prep room, this model eliminated the need for a separate tracking tool or additional data entry. The team stayed in control of the progress of all requests. In addition, daily summaries of complete and outstanding requests can be provided to relevant staff and management without extra efforts to clean the request log."
The cloud-based approach in managing inspections offers clear benefits. It is an attractive option for streamlining the backstage operations during an inspection, regardless of the focus of the inspection.