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Vestigo 5.3 Release Notes

Our recent 5.3 webinar covered four main topics:

  • Competency
  • Alert Pane Re-Design
  • Enhanced Security on User Accounts
  • Audit Log Expansion

For each topic, we have provided separate videos to allow users to focus on the topic of interest. Please reach out to support@mccreadiegroup.com with any questions.

COMPETENCY

Video: Protocol Specific Competencies

Video: Global Competencies

Video: Competency Reports

Several improvements have been made within the competency redesign:

  • Competencies can now be built directly on the Protocol, and users will be prompted to record completion before accessing the protocol. This streamlines viewing and completing a competency.
  • Global competency management allows for the creation of a competency library. These shared competencies can be imported and managed at the protocol level and only need to be completed one-time.
  • Competency role restrictions can be specified as Soft-Stop, Hard-Stop or No Access to provide varying levels of security.
    • When assigned a Soft stop, the user can bypass competency and follow site’s SOPs for completion.
    • When assigned a Hard Stop, the user must complete & record competency to access the protocol
    • When assigned No Access, the user cannot access the protocol
  • New reports and training logs globally and at the protocol level provide clear and concise information. The training logs will also be available to the monitor in Vestigo verify!
  • Additionally, enhanced competency checks have been built into several areas of Vestigo to ensure the user has permissions to access the protocol.

When preparing to implement Competency Management the site should consider the following factors:

Training SOP
Create a Training SOP that clearly outlines and addresses the staff member roles responsible for completing training, the types of documents that training will be performed on, the primary methods of training, and how this will be managed in Vestigo. The training SOP should also clearly inform users of the restriction levels that should be assigned to each role when creating a given competency type. Similarly, the SOP may want to outline the process for creating and managing training competencies in Vestigo.

Review User Roles & Permissions
It will then also be important to perform a review of the current User Roles and Users in the system. To do this, clean-up the system by inactivating former users and ensuring users are assigned the fewest roles to perform their required tasks. Use the Security Setting report to look at the permissions associated with each role and considering the tasks associated with each role, determine if these can be cleaned up or combined to limit the number of roles required for a given personnel.

Similarly, if there are non-pharmacy personnel in a role with pharmacy personnel, you may want to consider creating a separate role for these users if they are not to be completing training documentation.

Please remember that competencies do NOT apply to protocol-specific users. Therefore, depending upon the need, users may want to be added as protocol-specific contacts rather than being assigned a Vestigo user role. Please contact Support if you have specific questions regarding permissions or user roles.

Roll-Out Plan
Finally, it may be necessary to create a roll-out plan to transition to the use of electronic training completion in Vestigo. Some suggested approaches may be at first using competency for new protocols, or new document versions on existing studies. Users should practice creating and managing competencies on a test or dummy protocol.

ALERT PANE: ORGANIZATION AND RE-DESIGN

Video: Alerts

Vestigo Alert Pane has been re-designed improve speed, organization, and clarity among facilities of the site.
The new alert pane is tabbed by topics, grouping similar alerts together. This prioritizes, organizes and focuses the user on related items and those relevant to their daily task work.
The addition of a “My Facilities Tab” gives visibility to alerts across other facilities in which the user has role. The link to easily “switch facilities” from the alert directs the user into that facility to manage and resolve those alerts.
The ability to expand and collapse within the Facility Alert greatly enhances efficiency and speed, as results can all be viewed from within the home screen.

ENHANCED SECURITY ON USER ACCOUNTS AND EXPIRATION

Video: User Accounts

The 5.3 release will feature additional security checks to monitor Vestigo access and accounts. These measure will support safe and appropriate user access for compliance with 21 CFR Part 11. While many of these measures were already in place, they have been made much more robust with this release. On the day of Release, all users who have not had activity for 180 days within any Vestigo instance will be inactivated.

Previously, e-mail notifications were sent to detail any changes to user accounts. These emails will now contain more detail than ever, including new users, edited or updated users, locked users, and those that have been inactivated. This email will be sent to the security e-mail address designated in Application Administration. On the day of the release, the security administrator may anticipate receiving several notification emails if there are several site users who have not accessed the system in 180 days and will therefore be inactivated.

Finally, all changes to user accounts will be documented on a reportable security audit log.

As a refresher, we will now look over the Security Settings Features within Application Administration to ensure these are up to date and reflective of your site’s current security requirements.

AUDIT LOG EXPANSION

Video: Audit Logs

Audit logging capabilities in Vestigo have been expanded with the availability of new audit logs on the user interface. While previously tracked and recorded on the backend, this now gives the user enhanced readability and clarify to completely track edits and deletions.
In addition to the Protocol Audit Trail, a new Audit Trail section in Application Administration is available.
On certain transactions, an audit log link has been added in line with the grid to easily view and understand edits or changes that have taken place. Within the address book, changes to the contact record can be traced. Changes to monitor visits, drug returns, patient visits, and the subject record can all be pulled from an audit log in line with the transaction.