March 15, 2023
Loftware Prisym 360 release 1.17 streamlines label and booklet creation for clinical supplies
Release includes enhanced phrase and content management functionality to deliver efficiencies, improve accuracy, and streamline compliance
Portsmouth, NH — March 15, 2023 – Loftware, the global leader in Enterprise Labeling and Artwork Management solutions, today announced the general availability of Loftware Prisym 360 release 1.17. This latest release 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 labeling functions.
Clinical labeling 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 labeling can be a very resource-intensive activity, especially where processes rely on manual tasks or legacy systems.
“Loftware’s Prisym 360 labeling solution helps clinical supplies teams utilize 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 labeling functions can significantly reduce the timescales and risks associated with designing complex booklets during a study start-up phase, for example.”
For more information about mastering the translation of clinical trial labels, download Loftware’s complimentary report.
Loftware is the world’s largest cloud-based Enterprise Labeling and Artwork Management provider, offering an end-to-end labeling solution platform for companies of all sizes. Maintaining a global presence with offices in the US, UK, Germany, Slovenia, China, and Singapore, Loftware boasts over 35 years of expertise in solving labeling challenges. We help companies improve accuracy, traceability, and compliance while improving the quality, speed, and efficiency of their labeling. As the leading global provider of Enterprise Labeling and Artwork Management, along with Clinical Trials Labeling and Content Management, Loftware enables supply chain agility, supports evolving regulations, and optimizes business operations for a wide range of industries. These include automotive, chemicals, consumer products, electronics, food & beverage, manufacturing, medical device, pharmaceuticals, retail, and apparel.
- Clinical Trials