Loftware Prisym 360 release 1.17 comprises a wide set of enhancements to Prisym 360 to simplify and accelerate the design and production of accurate clinical supplies labels and booklets. This will deliver efficiencies, improve accuracy and streamline compliance for clinical labelling functions.
Clinical labelling teams often specify English Master Label Text (MLT) content to define the governing label content for clinical study labels and booklets. Once collated and approved, this MLT content is then used to create variations for each country and region to be included in the study, commonly referred to as Country Label Text (CLT). These variations typically include country-specific phrase translations, regulatory statements, and symbols.
Prisym 360’s unique MLT/CLT functionality, along with its phrase management and regulatory rules features, guides users through the process of defining and collating clinical label and booklet content. It automates many steps by reusing approved content and translations to remove unnecessary activities. PDFs can then be swiftly generated by applying this resulting content to label or booklet layout designs.
Additionally, with support for electronic records and electronic signatures, all activities are recorded in Prisym 360’s audit log, helping clinical supplies teams to ensure GxP-compliance.
Simon Jones, Loftware VP Product Management, Life Sciences, said, ‘As pharmaceutical sponsors continue to grow new product pipelines, clinical supplies teams are seeking opportunities to simplify and streamline their operations. Clinical labelling can be a very resource-intensive activity, especially where processes rely on manual tasks or legacy systems.’
‘Loftware’s Prisym 360 labelling solution helps clinical supplies teams use software to automate the steps in collating, formatting and translating text and symbols required on clinical pack labels or booklets. This release, designed with input from users to ensure it reflects industry best practices, further improves these activities by simplifying steps, improving content reuse across studies, and enhancing booklet layout options. As a result, clinical labelling functions can significantly reduce the timescales and risks associated with designing complex booklets during a study start-up phase, for example.’
LOFTWARE
https://www.loftware.com/
