Release 1.8 of PRISYM 360 introduces new features to help medical device and clinical trials organizations to achieve complete label integrity and to meet the strictest FDA & EU regulatory requirements.
The new release includes new features for:
- Master & Country Label Text (MLT/CLT) which helps clinical research organizations to use the concept of Master Label Texts to define the textual content for their clinical labels. The 1.8 release introduces features to aid with the definition of Master & Country Label Texts. It also provides a wizard which can automatically generate Country Label Text records for approval or printing.
- Help Topics which provide a mechanism to add contextual help to PRISYM 360. Help Topics are used to create a link between screens or content in PRISYM 360 to a PDF file. Out-Of-The-Box PRISYM 360 1.8 will come with preconfigured Help Topics which utilize the user manuals to provide contextual help to users.
- Name Templates which enable organizations to control the naming conventions used for content stored within PRISYM 360. Name Templates can be assigned to Phrase Keys, Entities and Folders at a system level, or further granularity can be achieved with the use of overrides.
Additionally, there has been enhancements made to Regulatory Rules, Approval Workflows and several other functional areas.
- Regulatory Rules enables organizations to pre-define what content should be present on a label design. In PRISYM 360 1.8 Regulatory Rules has been extended to support two new types of Regulatory Rule; Data Options and Data Values.
- Approval Workflow defines the steps and groups through which approval requests are routed. PRISYM 360 1.8 introduces a configurable option which enables reviewers to be able to annotate and provide feedback after a negative vote has been cast. The release also provides multiple ways to keep users notified of the progress of Approval Requests. Users can now be kept up to date regardless of their involvement in the approval process. The organizations can also now choose to have the user who casts the final positive vote on any given entity to be set as the final approver for that entity and they have an option to mark approval requests with a high priority flag.
Simon Jones, VP Global Products at PRISYM ID, explains: “The new features are not only enhancing the user experience, they are also helping medical device and clinical trials organizations to reduce the risk of label errors whilst helping to streamline production workflows. The 1.8 release is strengthening the benefit to our customers of our focus on life sciences labeling.”