Prisym 360
Prisym 360
Loftware Prisym 360 for clinical trials
Loftware Prisym 360 delivers innovative content management features which incorporate industry best practice, designed specifically to meet the highly complex regulatory requirements essential for clinical supplies labeling.
PRISYM 360’s dynamic label generation methodology – label templates are designed using placeholder variables which are populated with the necessary content or values dynamically, at the time of print – offers two significant advantages over traditional label design software: Firstly, a single label template can be used to produce many different labels, as the label content can vary. This allows for the number of label designs to be reduced significantly, as a single template may be used for man
PRISYM 360 is a fixed asset management software that helps businesses design label templates utilizing placeholder variables that are automatically populated with the required information and values at the time of printing.
It provides a single label template that allows staff members to produce many different labels with custom label content. It lets users reduce the number of label designs and utilize a single template across multiple products. Employees can extract label content at the time of print in specific languages, thus ensuring the use of the latest product data, such as expiry dates, company logos, and usage or dosage instructions.
PRISYM 360 can utilize several product models to streamline different print processes. The print processes within PRISYM 360 can generate labels in multiple use cases based on content and process logic, with associated user interfaces. The user interface functionality facilitates the selection and preview of labels and the input of variables and data specific to the print job.
Clinical trial booklet design
Clinical labeling teams often utilize English MLT/CLT variants to define the content for clinical trial labels and booklets.
As the number of countries included in each study increases, with each having specific regulatory content, phrase and language requirements, so the manual process of designing and printing booklets takes more time and effort, leading to greater risk of error.
Prisym 360’s MLT/CLT solution prompts users for study information, and then automates the generation of MLT, CLT and booklet design based on its knowledge of content and design requirements. This reduces clinical label and booklet creation from weeks to hours, ensures regulatory requirements are met and reduces risk of errors.
Just-In-Time clinical label printing
With the increase in biologics studies, the cost of clinical trial stock overage and the risk of clinical packs incorrectly labelled with out of date expiration and dosage information is significant.
Clinical supplies is 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’s Print Processes perform dynamic label generation, using label templates and logic to retrieve the latest approved content in real time to enable just-in-time printing and packing production models. This ensures the latest, approved expiration and dosages information is used, as well as enabling new supply models such as direct-to-patient.
Clinical label print inspection
Clinical labeling regulations require 100% labels are inspected for errors, but manual visual inspection of printed labels is laborious, costly and error-prone. Print inspection technology should help, but is difficult to set-up, and creates an operational overhead of running two systems, labeling and print inspection.
By knowing the label’s design and content, Prisym 360’s fully integrated Vision print inspection simplifies and automates real-time inspection on both the content and design of every printed label. This minimizes effort in inspection setup and operation, and identifies more errors at time of print.
Unique features for clinical trials
Phrase and translation management
Prisym 360 can manage translations for over 150 languages and regional variations, following the Unicode standard, as well as phrases and pluralization. Missing translations for label data can be quickly and easily identified, and translation request functionality can ensure these are completed without impacting production.
Change requests and approval workflows
Users can raise change requests to label designs or content, which can be routed to specific individuals or groups for approval, and then for action. Approval workflows define the steps and groups through which approval requests are routed. A workflow step can comprise individual users that are either required to make decisions or act as optional reviewers.
Clinical master data connector
Prisym 360’s Clinical Data Connector heavily simplifies the integration of Prisym 360 with clinical trial supplies applications, by providing a flexible, pre-defined interface for the communication of data. It supports industry-common protocols and standards, such as Web Services, SOAP and REST, to maximize its compatibility with external applications.
Label randomization
Randomization functionality enables the generation of randomized label data from an uploaded source file. The resulting Randomized data file will be stored and version controlled within Prisym 360, and used to produce production labels.
Regulatory rules
Prisym 360 enables Labeling and Regulatory teams to pre-define label design and label data ‘Rules’. Automatic evaluation on whether a label conforms to Rules is performed in real-time, within Label Designer and Approval Requests, to reduce the risk of regulatory non-compliance due to incorrect label design or missing content.
Validation and GxP compliance ready
Each release of Prisym 360 is designed, tested and delivered with a full validation documentation pack, comprising auditable security protocols and lifecycle documentation based on ISPE’s GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems guidelines.
Flexible deployment options
Cloud
Prisym 360 is deployable as a Software as a Service option, with all the technology, security and upgrade benefits from a platform within a GxP validated Cloud environment.
On-premise
Where preferred, Prisym 360 can be deployed onto customers’ premises, using Installation Qualification and Operational Qualification documents provided by PRISYM ID.
Products
Labeling
Redefine how you create, manage and print labels
Loftware helps businesses of all sizes manage labeling across their operations and supply chain. Whether you have five printers or thousands, looking for cloud or on-premise, we’ve got a labeling solution that fits your business requirements.
The industry’s most comprehensive labeling solutions
All-in-one labeling solutions
By standardizing the entire label printing process into one platform, Loftware redefines how organizations manage complex and mission-critical labeling operations.
Certified integrations with business systems
With Loftware’s certified integrations to leading business applications, such as Oracle and SAP, you can connect labeling with any of your existing business systems to streamline and automate your labeling processes.
Labeling built for the Cloud
Loftware’s labeling solutions are designed to be run in the cloud, helping you achieve the highest level of print performance and reliability for your mission critical labeling.
Putting label management in the hands of business users
Our intuitive interfaces and WYSIWYG design capabilities make it easy for business users to manage the label design process. This frees up costly IT resources and creates a more efficient label design and management process.
Meeting your unique labeling requirements
You can configure our labeling solutions to support your business processes and to satisfy specific customer, industry and regulatory requirements. Our solutions also include pre-designed label templates and applications that comply with common industry regulations.
Industry best practices and first-class service
With extensive services, support and training available for all your labeling needs, we are always here when you need us…anytime, anywhere – around the globe.
Why artwork management in 90 seconds
Save time and avoid errors by eliminating manual processes such as email and spreadsheets that don’t manage packaging artwork well.
Artwork Management for Dummies
A basic guide to cloud-based packaging artwork management and how to free your team and partners from old manual processes
Pros:
- Importing and exporting data is very easy and efficient. Budget and scheduling integration is awesome!
Cons:
- It would be great to have a corresponding web-based interface where you can make changes to projects.
PRISYM 360 Pricing
Pricing overview
Value for money rating
5.0/5
Price starts from: Per User ; $30.00/Per-Month
