We recently updated our technology-neutral GxP Inspection Plan template and moved it to a more prominent location on our web site. We have also added a new SOP template, to help you develop a GxP inspection plan specifically when using Ready Room. The information below will help you understand and customize that template for your needs.
General information. Determine which Ready Room "Program" will be used to hold the inspection, the inspection name, the name of the inspectee, and the planned start date. Keep in mind that the Program in which the inspection is created will determine which storyboards and labels are shared with the inspection team. For the inspection name, consider a naming convention that will help orient users who have access to more than one inspection - for example, [Regulatory Authority] [Program] [GXP] Inspection [MONTH YEAR].
Enter these details into the Settings → General Information section of Ready Room.
In this section, also capture the physical location of the inspection, if the team will be co-located.
Ready Room Columns and Workflows. The inspection plan reflects Ready Room's default six-column workflow. Determine whether the Secondary Review column will be hidden or visible. Some teams prefer to have one level of review for content and another level of review for Good Documentation Practice. Other teams prefer to call in secondary reviewers on an ad hoc basis.
Adjust column names, colors, and labels to fit the team's preferred workflow. We find it is easiest for the team to understand the workflow when the Column Label is semantically close to the Column Name. We like the rainbow theme, but the colors are up to you.
Enter the settings into the Settings → Columns section of Ready Room.
Ready Room Roles and Permissions. The inspection plan reflects the default roles and permission sets. Determine the role names, colors, and permissions that will support your workflow.
Some things to consider:
- By default, the Communicator, Assigner, Subject Matter Expert, Ready Room Reviewer, Secondary Reviewer, Host, and Scribe all have the same permissions. This configuration permits the most flexibility by allowing users to exercise nearly all features and to switch among these roles at will, but it does require some training to encourage team members to "stay in their lane."
- Most teams will want to put restrictions on permissions that could potentially interact with the inspector. These are Modify Inspector Review Column; Upload to Shared Storage; Complete Request; and Invite Inspectors (to chat and briefings). In most teams we work with, the Host and Inspection Admin have these permissions, but no one else.
- Some teams prefer to "lock down" permissions so that each role can play their part, but none other. To permit a role to act within a particular column, the role must be given Modify permissions for its column and for the columns before and after it. For example, the Subject Matter Expert would have permission to modify the Assign, Fulfill, and Ready Room Review columns, but would only be able to View Host Review and Inspector Review columns (or you cam hide them entirely). If you have a small team, however, and people may need to double up on roles, this could prove restrictive.
- Existing roles may be deleted, renamed, and assigned any set of permissions. New roles may also be created, if you need more roles than the 10 default. Some teams, for example, set up a Printer role to facilitate hard-copy requests.
- Vendors and consultants can provide valuable support to small teams during inspections. Utilize the Restricted SME role as a basis for these users, modifying it as needed to give these team members access to parts of the inspection they are authorized to see.
Enter these settings into the Settings → Roles section of Ready Room.
Other Roles and Responsibilities. Non-Ready Room roles may include the Senior Executive who receives the inspection notice; a Front-Room Subject Matter Expert who supports the host; an IT representative who provides connectivity and hardware support; a Receptionist who receives the inspector; and a Runner who delivers materials and escorts the inspector to and from the inspection room. Modify, add, or delete these roles as needed.
Ready Room Team Members. Team members are organized by Core Inspection Team; Subject-Matter Experts for Interviews; Subject Matter Experts for Document Retrieval; Restricted Subject-Matter Experts, and Other Roles. First, modify the Role names to match your previous selections, then list the name, title, and phone number of every person who will be assigned a role in the inspection.
If you find that a person doesn't fit neatly into a single role, consider whether your Ready Room roles should be modified.
There is no limit on the number of users you can add to an inspection - you will not be charged extra! - and users do not have to be part of your domain. Keep in mind that users who are not under your single sign-on configuration will have to set up a separate password for Ready Room.
Add users in the Settings → Team Members section of Ready Room.
Ready Room Inspector Set-Up and Shared Storage. In this section, you will capture the inspector's real name, generate synthetic login credentials, and enter the details of any shared folders that the inspector has asked you to use for request delivery. Some things to keep in mind here:
- The inspector can see their display name in Ready Room, and inspectors who receive cover sheets with hard copy requests will see their display name on the cover sheet.
- Shared storage must be set up for any inspector that has requested documents through a shared storage repository. If two inspectors are accessing documents through the same SharePoint folder, for example, shared storage must be set up twice, once for each inspector. In order to use shared storage, an inspector's name must be captured in the request.
Set up the inspector in the Settings → Team Members section of Ready Room.
Ready Room Settings. This section captures all the questions in the Settings and AI sections of the inspection configuration UI. Determine which selections will be made, then make them in these sections.
Ready Room Request Fulfillment Process Flow. This section details the standard process flow for requests in Ready Room. Modify it with your specialized Ready Room roles, column names, and preferred workflow.
Document Repositories. In this critical section, you will list every repository that holds documents that might be requested during an inspection and summarize who has access to each repository. We've included some record types to start you thinking, but please consider your TMF index or other document that lists record repositories. There is nothing worse during an inspection than realizing that the only person who has access to a particular repository is on vacation.
Ready Room Interview Process Flow. This section details a common process flow for interviews. Modify it with your specialized Ready Room roles, column names, and preferred workflow.
Ready Room Labels. In this section, you can document labels to be used for the inspection and rules for use. We find it's better to respond to an organic need with a label than to plan too many labels in advance. Some teams use labels to reflect the following states:
- Urgency or priority
- Topic
- Potential finding or sensitive issue
- Study (for programs with multiple pivotal or inspected studies)
- Department
Review your Request Fulfillment Workflow to ensure that it captures which role is adding labels and when.
Account-level labels are defined in Account Settings. Program-level labels (preferred) can be accessed through the Program Settings or from the inspection via the "label" icon.
Business Rules. This is the place to define general business rules that don't fit into the workflows or other sections. We've included some common questions; delete, modify, or add to them as needed.
Inspection Room Set-Up. In this section you'll define the physical spaces that will be used as the inspection room (front room), back room, strategy room, and lunch room. The table captures equipment that may be required in each room. Modify as needed. This blog post may be helpful.
Advanced Requests. If the inspector asks for documents before the inspection, this section describes how they will be delivered. We find it easiest to capture and fulfill these requests via the standard Ready Room process.
Staging. This section details which documents will be staged prior to the inspection. Staged requests - what the inspector MIGHT ask for - are different from advanced requests - what the inspector has ALREADY asked for. We've listed some common staged items; modify as needed. Keep in mind that staged items can be selectively copied (for example, you can stage five protocols and then just activate the one that's asked for, leaving the others behind for other requests).
Meeting Processes. This section can be used to define roles and responsibilities for requesting and scheduling meetings and distributing meeting minutes.
Post-Inspection Tasks. Capture roles and responsibilities for any post-inspection tasks here, including deactivating inspectors, archiving inspection records, and locking the inspection.
