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Ready Room is pleased to announce support for pre-staged inspection requests.
Inspectees frequently start preparing for an inspection days before the inspector actually arrives. This is typically because the inspector has submitted a list of documents they expect to have available upon arrival, although there are other documents that inspectees like to have teed up just in case. The workflow for these pre-staged requests is identical to that for "live" requests: both need to be assigned to and fulfilled by a subject matter expert and the response and documentation need to be QCd. The difference is what happens after the Inspection Host has reviewed the documents: inspector requests are released as soon as they are available, but pre-staged requests need to be held until they are specifically requested. And this means that pre-staged requests, indistinguishable from inspector requests, tended to clutter up the Host Review column.
Users asked for a way to distinguish regular requests from pre-staged requests, so Ready Room delivered: a Communicator can now mark a request as staged upon creation, or any user can add that designation at any time thereafter. On the workflow board, staged requests are made visually distinct with a blue gradient header and a globe icon in the footer (because all the world’s a stage – or something). Now you can see at a glance which requests are staged and which are live.
In addition, a new toggle switch at the top of the Inspection Host column hides/unhides all staged requests in the column, so team members can focus on the live requests, or unhide the staged requests to search for a document that's ready to go if the inspector happens to ask for it. This feature works similarly to the toggle that hides "completed" requests in the Inspector Review column:
When editing a task, you'll now find various pieces of metadata on the top of the card, right next to the History tab, including the Staged toggle, the Complete toggle (for requests in Inspector Review), and the current state of the request.
Denise DeRenzo Lacey, RQAP-GCP, has over twenty years’ experience in clinical Quality Assurance and clinical development operations. Her practice focuses on application of quality risk management techniques for clinical studies, including risk-based approaches to auditing, data quality and integrity, and SOP development. She has provided consulting services to a wide range of pharmaceutical, medical device, biotech and CRO clients in the US and Europe and has held senior positions at Vertex Pharmaceuticals and Radius Health.