FDA Inspection Readiness, Rehearsal, Request Management, Response - and Risk Reduction

Inspection Readiness, Rehearsal, Request Management, Response - and Risk Reduction

Be ready for:

On-site inspection, virtual visit, or working from home. Announced or unannounced inspection. Internal audit or partner due diligence review.
Be ready for anything.

Take control of your next GXP Inspection before it’s announced.

Ready Room is a cloud-based solution that helps your team prepare for an inspection throughout the program and execute flawlessly on inspection day:

Ready Room’s custom inspection interface puts the status of every request at your fingertips whether you’re in the front room, the back room, or working from home.

STEP 1: GET READY

Develop a storyboard for a quality story

Use Ready Room’s storyboard tool to develop talking points to help interviewees respond to inspection questions.

Develop a quality storyboard
  • Storyboards pre-populated with expected GCP, GMP, and GPV inspection questions and “fill-in-the-blank” frameworks for responses.
  • References to FDA, EMA, and MHRA inspection guidances.
  • Storyboard frameworks for generic process, problem and role/responsibility questions.
  • Rich-text formatting.
  • Ability to attach unlimited documents to storyboards.
  • Labels, categories, assignments, and other metadata.

STEP 2: REHEARSE

Practice for a perfect performance

Construct a personalized deck for each prospective interviewee and use Ready Room’s “flashcard” feature to conduct practice responding to interview questions.

  • Filters to winnow deck by category, assignee, keywords, and other metadata to construct a personalized deck.
  • Flashcards with the question on one side and answer on another.
  • Unlimited training and mock inspections for unlimited practice.
  • Ability to invite both internal and external team members to practice with unlimited users.
  • Storyboard copy tool from one inspection to another for re-use or modification.
  • Storyboard export to .pdf.

STEP 3: MANAGE REQUESTS

Collaborate effortlessly with the team to manage requests

On inspection day, use Ready Room’s inspection board to capture, manage, and assign requests; enter formal responses and attach documents; and deliver responses electronically to the inspector. The color-coded board lets the whole team visualize the status of each inspection request at a glance, while scribe notes, comments, video briefings, and chat facilitate communication.

  • Capture new requests with just a few keystrokes.
  • Staging to prepare responses to expected questions before the inspection starts.
  • Simple drag-and-drop workflow to assign requests, attach documents, write formal responses to questions, and review completed tasks.
  • “Storyboard to request” feature turns a storyboard question into a request with a single click.
  • “Liveview” feature updates all team member screens in milliseconds.
  • Co-activity indicators (who else is currently working on a request).
  • Comments to keep communication flowing up and down the workflow.
  • Multiple, rich text scribe notes that can be monitored in real time from the inspection board and viewed in one or more separate tabs or windows.
  • Filter requests by assignee, inspector, or request characteristics to maintain focus
  • “Restricted SME” role for team members who contribute documents but don’t need to see all inspection activity
  • Audit trail for each request
  • Export tool to export requests singly or en masse, with a cover sheet for each
  • Inspector Portal to share documents electronically with the inspector.
  • Box integration to upload documents to preferred FDA content manager.
  • Schedule secure integrated video briefings with team members and external partners.
  • Use chat to keep the team connected.

STEP 4: RESPOND

It’s a wrap

Post-inspection, download a complete archive of inspection activity and use the debrief tool to capture potential findings and CAPAs while the inspection is fresh in everyone’s mind.

  • Debrief notes for each request to track potential findings and capture lessons learned.
  • Export tool to generate a complete request history as a permanent record of the inspection, including metrics for delivery.
  • Archive tool to deliver a zip file of all documents released to the inspector.
  • Scribe notes export to generate a .pdf file of all notes captured during the inspection.

How Do You Get Ready to Tell a Quality Story?

A clinical program is inspection-ready when the inspection team can deliver documentation to the inspector that tells a quality story about its execution. Prepare with this practical step-by-step guide to GCP inspection readiness.

Are you ready?

Find out how Ready Room can become your GXP inspection solution. No software to install. Nothing to configure.