Loftware Prisym 360 for clinical trials

What is Loftware Prisym 360 for clinical trials?

Loftware Prisym 360 offers innovative content management capabilities that incorporate industry best practices, specifically designed to meet the highly complex regulatory requirements essential for clinical supply labeling.

Built to overcome the challenges of providing clinical trials

Automates the design of clinical booklets

Ensures regulatory compliance of labels and brochures

Reduces time and effort in label design and production

Simplifies GxP compliance and validation

Clinical trial booklet design

Clinical labeling teams often use MLT/CLT variants in English to define the contents of clinical trial labels and leaflets.

As the number of countries included in each study increases, each with specific regulatory content, phrase and language requirements, the manual process of creating and printing leaflets takes more time and effort, leading to a higher risk of error.

Prisym 360's MLT/CLT solution prompts users for study information and then automates mlt generation, CLT, and booklet design based on their content knowledge and design requirements. This reduces the creation of clinical labels and leaflets from weeks to hours, ensures that regulatory requirements are met, and reduces the risk of errors.

Just-in-time clinical label printing

With the increase in biological studies, the cost of overstocking clinical trials and the risk of incorrectly labeled clinical packaging with expiration date and dosage information are significant.

Clinical supplies are challenged to shift from traditional production and supply models, such as batch production, to a more flexible on-demand or Just-in-Time model.

Prisym 360 printing processes perform dynamic label generation, using label templates and logic to retrieve the latest approved content in real time to enable just-in-time print and packaging production models. This ensures that the latest and most approved expiration and dosage information is used, and allows for new delivery models, such as direct to the patient.

Clinical label printing inspection

Clinical labeling regulations require labels to be 100% inspected for errors, but manual visual inspection of printed labels is laborious, expensive, and error-prone. Print inspection technology should help, but it is difficult to configure and creates a two-system execution operational overhead, labeling, and print inspection.

By knowing the design and content of the label, Prisym 360's fully integrated Vision print inspection simplifies and automates real-time inspection of the content and design of each printed label. This minimizes effort in the configuration and operation of the inspection and identifies more errors at the time of printing.

System requirements:

CPU: 1.8 GHz dual-core processor

RAM: 2 GB

HDD/SSD: 50GB free space on main drive

Operating system: Microsoft Windows 10, Microsoft Windows 8 32-bit, Microsoft Windows 7 32-bit and Microsoft Windows Vista 32-bit

Resolution: 1024 × 768