Features
Manage your storyboards, inspections, and teams in one place, with all the features you need to thrive during GXP inspections.
There are two main components to Ready Room: Inspection Readiness and Inspection Management. - Together, they allow the QA department of a life science company to prepare the rest of the company for upcoming inspections and then to manage those inspections once they are underway.
Inspection Management
The inspection management component is the heart and soul of Ready Room, allowing you to easily manage and respond to regulatory requests, even with a globally distributed team. It replaces your current ad hoc practices with a proven, visual, and intuitive workflow, greatly reducing the risk of delays and findings.
Inspection Board
The inspection board is where the magic happens. It helps your team keep track of requests, alleviate bottlenecks, and gain real-time visibility into the state of the inspection.
Create an inspection
There's no limit. Create as many inspections as you want.
It takes only seconds to create and there's nothing to configure (unless you want to). Just fill in a few fields and click "Create." Create training, mock, and actual inspections.
Workflow View
Intuitive and accessible, your team will barely need training.
Ready Room provides an open five-stage workflow, from assign to release. Each stage is represented as a column, and columns are color coded to map to a team member's persona. Requests can be dragged and dropped from column to column, and vertical position is maintained. When requests enter (or re-enter) particular columns, associated team members are notified that their attention is needed.
Table View
Prefer to view requests as a table? No problem.
At the click of a button switch to a simple table view of all requests. This is valuable because it's the table view that allows you to sort requests.
Filters
Focus on what's important.
After a few days, the inspection board can get rather busy. Use Ready Room's powerful filters to focus on what you need to see. Filter by content, label, inspector, assignee, creation time and more. Importantly, filters are persistent. This allows you to split an inspection into arbitrary workstreams, say if multiple inspectors show up.
Real-Time Updates
No more clicking refresh.
Every change to the state of the inspection is reflected immediately on every user's desktop, keeping the team perfectly in synch. Every time a request is created or updated, those changes are immediately propogated out to every user, regardless of where in the world they're sitting.
Presence
See who's looking at the inspection board.
As users enter and leave the inspection, their avatar is added and removed from the inspection screen. Now you'll always know when a team member is active.
Tabs
Quick access to common filters
See the requests an inspector actually asked for. See Staged Requests, only your requests, deleted requests, or every request ever.
Request Management
When the inspector requests answers, documentation, or a SME to interview, this is captured in a "request," which is rendered as a "card" in the UI. From the time it's created until it's released, team members can assign particpants, create responses, upload documents, add comments, and more. It's a metaphor that just works.
Create a Request
A Communicator in the 'front room' captures inspector requests effortlessly.
Add a brief summary of the requests and, if necessary, a more detail description. You can even add a custom ID, labels, and the requesting inspector. New requests show up in the "Assign" column on everyone's board.
Staged Requests
Get ready days or weeks ahead of time
There are some things that you just know the inspector's going to ask for. For these you can create 'staged' requests and send them through the workflow. Staged requests are kept separate from actual requests. If and when the inspector actually asks, just click the 'Activate' button to copy all or part of the staged request to the inspection board.
Copy Requests
Flexibility when you need it
Copy requests within the current inspection or to other inspections. Select whether to include labels and assignees. Even choose which attachments should be copied. Ideal for moving tasks from staged to active (or vice versa), breaking large requests into smaller ones, or bootstrapping a new inspection.
Assign Particpants
An Assigner in the 'back room', opens the request, reads through it, and chooses the team members that will work on it.
You can add a primary assignee, a backup assignee, and a reviewer. The assigned team members are notified immediately when the card needs their attention.
Locate Requested Documents
Use our AI-enabled TMF Locator to easily find supporting documentation
Out integration with <a href="https://openai.com>Open AI and our extensive industry experience allows us to automatically infer the TMF location of asked for documents from the natural language used in the inspection request.
Fulfill Request
Subject Matter Experts can easily attach documents
Add a rich-text (lists, tables, links) response or attach documents. File upload is an easy drag & drop operation. Files are stored securely in the cloud and there is no limit on the number of attached documents.
Interviewee Debriefs
Track interviews with an inspector
Does the inspector need to talk with a subject matter expert? Create a ticket, assign the SME, and set up a video briefing. When the interview is complete, capture debrief notes on the ticket.
Quality Control
The assigned Reviewer QCs the request
Using the integrated file viewer, a reviewer can quickly click through any attachments to verify that the response is correct and well-presented. If not, they can send it back to the SME, or send it forward to the front room Host who can release it to the inspector.
Labels
Add custom meta-data to a request
Easily create color-coded labels and add them to requests and storyboards to signal additional information to the team. Consider 'action' labels e.g., Urgent or Revise. Or labels that signal the type of request, e.g. Legal or Data Management. Labels can exist at the account level for use globally, or they can be scoped only to the inspections and storyboards within a program.
Links
Capture relationships among requests
It takes only a click to create (or remove) a bi-directional link to any other request in the inspection.
Audit Trail
See every significant change
Every change to a request's state is logged and is visible with a click. Now you'll know exactly who did what when. We even track when inspectors view or download attachments.
Collision Avoidance
See who's editing the same request you are
When more than one team member is viewing the same request, their avatars are shown to the left. And if they make any changes, the change is shown to the right. This helps to keep users from overwriting another person's work.
Team Management
After creating an inspection, it's time to start building your inspection team. Invite anyone from anywhere, including external partners, such as labs and CROs. You can even add inspectors!
Invite Team Members
Add as many people to the inspection as needed. There are no license restrictions.
Adding team members to an inspection is as simple as pasting in one or more email addresses and clicking "Invite." Users already in the system will be notified and added. New users will be invited to use Ready Room. Users can join from anywhere, they do not have to be employees of your firm.
Personas
Personas signal to the team what hat you're wearing.
There are six unrestricted personas: Communicator, Assigner, SME, Reviewer, Host, and Scribe.
There are also three restrcited personas: Restricted SME, Observer, and Inspector.
An admin gives a team member their initial persona. To accomodate dynamic and lengthy inspections, if a team member has an unrestricted persona, they can change it at any time.
Restricted SME
Limit what certain SMEs can do
The Restricted SME persona limits the user's access to just the requests assigned to them. Restricted SMEs can only add responses, documents, and comments to these requests. Furthermore, they lose access to the request once it's been approved. In addition, Restricted SMEs can not see chat or scribe notes. This is the ideal persona for external partners and internal people with minimal training.
Observer
You can look, but you cannot touch
Team members given the Observer persona have view-only access to the inspection. They can see everything, but they can change nothing. This persona is useful for senior executives or even for displaying an ongoing inspection in a common area.
Inspector
A persona that grants limited access to released requests
Adding an inspector allows you to mark a task with the requesting inspector's name. Later you can filter on that information and even upload documents to the inspector's Box or Teams account. Inspectors can also login to the system to access a very limit view of released requests. More on all this below.
Collaboration
Ready Room provides all the tools you need to keep everyone on your team communicating, collaborating, and in synch.
Notifications
Get a team member's attention
Every time a request is moved into the Fulfill column, Ready Room will notify the assignees. And when it's moved to Review, we'll notify the reviewer. We will also notify team members when they are @mentioned in comments or chat.
A notification consists of an email, a pop-up on their display, and a persistent message in the notification panel that they can click on to view.
Chat
Real time messaging.
Ready Room provides integrated chat. Every inspection has a default chat for inspection participants. Team members can create any number of separate conversations with other team members—even inspectors. Use @mentions to notify team members as described above.
Reggie
An AI-powered chatbot to assist with regulatory questions.
Start a chat with Reggie and ask it anything about the regulations and guidance surrounding drug and medical device development.
Briefings
Easily video-chat with any and all team members or inspectors
Ready Room has partnered with Whereby to provide powerful, secure, and intuitive video conferencing, screen sharing, and chat right from the inspection screen. No download is required, and it "just works" in any browser.
Briefings are ideal for setting up interviews with inspectors, troubleshooting, team debriefs, or even all-day live team calls.
Scribe Notes
Keep everyone up to date with what's happening in the front room
Using Ready Room's auto-saving rich-text editor, Scribes can keep detailed minutes of what's happening in the front room. While other team members can follow along in real-time with our auto-scrolling viewer. Team members can scroll backwards even as the scribe continues to type. Powerful auto-formatting features support the touchiest of touch typists. And Grammarly integration means fewer typos. Create as many scribe notes as necessary. One per inspector per day looks to be the norm. Scribe notes can be searched, deleted, printed, and exported.
Delivering Responses
Ultimately, formal responses and documentation need to be delivered to inspectors. Don't worry, Ready Room has you covered.
Inspector Portal
Grant limited Ready Room access to inspectors
Via the inspector portal, inspectors can get a limited view of all released requests, seeing the initial request, the formal response, and the attached documents. Inspectors can view or download (configurable) attachments. They can mark tasks complete so as to filter them out of view. They can even request clarification of a response, sending the request back to the inspection team. Finally, the portal makes Briefings easily available to inspectors so they can interview remote SMEs. Oh, and if you want to, you can disable their access at any time.
Upload to Shared Storage
Inspector won't login? No problem. Upload to Box, Teams, OneDrive, or SharePoint Online
More and more these days, inspectors are sharing with inspection teams folders from vaious storage providers. With just a few clicks, you can integrate Ready Room with Box, Microsoft Teams, OneDrive, or SharePoint online so that you can upload released documents and cover sheets for inspector access—with arbitrary sub-folders. And if the inspector doesn't have an account with a storage provider, use yours!
Download for Manual Delivery on Removable Media
Inspector insists on using a flash drive/DVD/floppy disk? We got you.
Each requests has two permanent, dynamically generated files: a cover sheet (i.e., a PDF summarizing the request and suitable for giving to an inspector) and a zip file containing all attachments and the cover sheet. You can download that zip or download each file individually for copying to other media as requests are released. Or download a zip file of every file and every cover sheet across all released requests.
Metrics, Analytics, and Visibility
Team leads need information to successfully steer an inspection to completion
Status at a Glance
The workflow board is rich with information
The continuously sychrnonized inspection board provides current status at a glance. Not only does each column have counts of requests and attachements, the location of the cards tells a story. Is the Fulfill column getting too long? Maybe there's a SME who could use assistance. Need more information about a request? Click into it to see comments and change history. In addition, subtle color cues and creative labeling can tell you if requests are being ignored, taking too long, urgent, blocked, and more.
Metrics
Powerful metrics and analytics are availble to more deeply unserstand and manage an inspection
Get rich, dynamic metrics about the number and status of requests, labels, attachments, and more. Get deeper insights into which SMEs are performing well or which may be overloaded. See the mean time it takes to release tasks by assignee and inspector. Use our powerful cumulative flow diagram (CFD) to visualize the inspection over time and spot bottleknecks or excess capacity.
CSV Output
For when you just need a pivot table
At any time, a team member can download a CSV containing every request in the system, which you can then open in Excel and manipulate as desired. Not enough? You can also download every request and every change that was ever made to it.
Inspection Readiness
Storyboards allow you to develop your 'quality story.' Unifying stakeholders on the events and decisions that took place over the course of a clinical trial. The inspection readiness component implements centralized storyboards. Ready Room storyboards replace your current storyboard solution, which is most likely a series of PowerPoint decks on a shared drive somewhere.
Storyboards
Prepare your team for upcoming inspections
Programs
Associate storyboards with multiple inspections
A program is a named collection of inspections that share storyboards. You may use this to group training, mock, and actual inspections together. Or share storyboards for a single therapeutic across FDA, EMA, and other regulatory bodies.
Storyboard Workflow
Manage storyboard development with a multi-step workflow
Ready Room provides a six-stage, drag & drop workflow to help with storyboard development: Pending, In Process, GXP Review, Documentation Review, Leadership Review, and Ready. Every stage can have a primary owner and multiple collaborators.
Table View
Prefer to view storyboards as a table? No problem.
At the click of a button switch to a simple table view of all storyboards. Use the column headers to sort storyboards as desired.
Storyboard Templates
Don't start from scratch, choose from over 200 prebuilt templates
Ready Room provides three generic templates: process, problem, and role & responsibility. More importantly, Ready Room also provides more than 200 GCP, GMP, and GVP templates. Just select the ones that apply to your clinical trial and fill in the blanks.
Tell Your Story
Create and refine storyboards over time
Use Ready Room's rich-text, auto-saving editor to create effective storyboards. Add images, tables, and links as needed. Upload relevant documents and associate metadata, such as protocol, site, and labels.
Rich Metadata
This ain't just PowerPoint
Add rich-text comments that stay with the storyboard. Use @mentions to get someone's attention. Upload supporting documentation. Add labels, category, protocol, and site.
Flash Cards
Practice, Practice, Practice
Assign storyboards to one or more team members. Use our unique "flash card" feature, to coach SMEs on how to correctly and concisely present the information to an inspector.
Filter and Sort
Find the storyboards you need
Over time, you may amass hundreds of storyboards. Use Ready Room's powerful filters to find just the ones you need. Filter by ID, assignee, label, content, category, protocol, and site. Use the table view to sort rows as desired. Easily cycle through each of the filtered and sorted storyboards.
Convert Storyboards to Inspection Requests
Deliver the information
During the inspection, you will likely be asked for the information contained in the storyboards. You can create an inspection request from a storyboard at the click of a button.
Copy Storyboards to New Programs
Reuse storyboards across programs
Even inspections that are not logically grouped together will have storyboards that are largely the same. In Ready Room you can copy storyboards across programs, so you don't have to create them from scratch every time.
Manage Storyboards
For any other use case
Print all storyboards or output to PDF. Export storyboards to CSV for use in Excel. Delete storyboards individually or in bulk. Restore deleted storyboards.
Proven inspection management for the life Sciences industry
Biotech, pharmaceutical, medical device, CMOs, CROs, and laboratories big and small are getting ready with Ready Room.
Comments
Keep the conversation where it belongs
Add rich-text comments that stay with the request. Use @mentions to get someone's attention.