PRISYM 360 PLATFORM
Regulated Content & Label Management
PRISYM 360 overview
PRISYM 360 provides clinical trial, pharmaceutical and medical device organizations with complete label integrity to meet the strictest compliance requirements for FDA & EU regulations, specifically FDA 21 CFR Parts 11, 810, and 820.
By focusing on the data, rather than the label, PRISYM 360 enables a revolutionary 360° outlook of your master data assets and provides the ability to control and optimize them to create a fully integrated approach to label management along the complete lifecycle, from design to inspection.
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 many products. Secondly, as the label content is retrieved at the time of print, only the most up to date data, in the required local language, is used - be that expiry dates, company logos or usage or dosage instructions.
PRISYM 360 can manage different print processes which support a wide range of production models. Each PRISYM 360 Print Process comprises content and process logic, with associated user interfaces, for generating labels to print in different use cases. The user interface facilitates the selection and preview of labels as well as the input of variables and data specific to the print job, such as expiry dates, at time of print.
FDA 21 CFR Part 11 compliance
Unlike enterprise labeling platforms, PRISYM 360 was designed from the outset to support for electronic records, electronic signatures and audit logging, simplifying FDA 21CFR part 11 compliance.
PRISYM 360 stores all data and actions as Electronic Records, and these cannot be subsequently changed or deleted which ensures the data is retained. These records can generate human readable copies or be exported in electronic format. Full Electronic Signature captures username, date and time and signature reason for all activities requiring e-signature verification.
PRISYM 360 enforces comprehensive version and revision control on every data component. If approved entities are changed, their version number is incremented automatically, changes are subject to approval, and are audit logged. Extensive audit log searching and filtering options aid in fast and accurate reporting to aid in regulatory audits.
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.
Significantly, GAMP 5 advises regulated organizations to leverage their system supplier’s knowledge, experience and documentation in order to perform validation. It is this approach that PRISYM ID encourages in order to avoid duplication of effort.
PRISYM 360 is developed using definitive and structured testing practices, based on standard software development lifecycle models, which result in a significant amount of evidence-based documentation. This includes Installation Qualification (IQ) and Operational Qualification (OQ) documents, which can be leveraged to assist in the creation of Performance Qualification (PQ) documentation, to facilitate a more rapid deployment whilst minimizing risk to project delivery.
PRISYM 360 comprises unique functionality to manage label content, the design of the content, as well as the processes necessary to request, review, approve and print / output regulated content for use in labels, inserts and packaging. Significantly PRISYM 360 includes label inspection technology to prove the label printed is the label expected. These features encapsulate the industry best practices we have identified in our 15+ years of clinical research and medical device labeling implementations, so new users can capitalize on the experience of their peers, to maximize efficiency and compliance. The following are examples:
LANGUAGE AND PHRASE MANAGEMENT
The software supports multi-language labels, the languages and phrases printed can be determined automatically based upon the country data. Managing language phrases and translations is a complex task. 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.
To extend functionality to artwork teams using Adobe Creative Cloud, PRISYM 360 includes an Adobe InDesign plugin to make content accessible from it. In addition, Adobe InDesign files can be uploaded to PRISYM 360, along with pdf versions, to be managed, approved, version controlled and searched. Integration with industry leading artwork comparison tools allows artwork files to be automatically proofed for differences and errors.
CHANGE REQUESTS AND APPROVAL WORKFLOWS
Users can raise requests for changes to label designs or content, which can be routed to specific individuals or groups for approval, and then for action. They include descriptions of the change, the content that requires the changes and links to any related content. Once a change request has been completed, an approval request can be automatically generated to route this changed content for approval. A change request dashboard offers a simple, clear view of the number and status of all active change requests.
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. Additionally, workflow steps may comprise groups of users for voting; quorums can be set to specify the minimum number of positive votes required to pass the approval step.
Once defined, approval workflows can be saved as templates for easy use or amendments, with each workflow template subject to approval and version control. Approval step milestones can be set to aid tracking of approval workflow progression, with clear display through an approvals workflow dashboard.
As PRISYM 360 keeps track of the usage links between content, it can quickly provide details of the labels, booklets or multi-page documents that make use of certain content, such as specific images or phrases. This is often referred to as ‘where used’. Searching on content entities will provide results in either a detailed table which can be exported, or in a graphical relationship view that enables the navigation of content links visually. This proves invaluable when a logo, product name or compliance statement needs to be changed for example, and finding all the places where it is used would otherwise prove a significant administrative activity.
PRISYM 360 Vision ensures labels are automatically extensively inspected as part of the label print process. By comparing a captured image of the printed label with the precise expected output, including design, barcodes and variable data, printing errors are automatically identified, alerted and recorded, even if undetectable by the human eye. PRISYM 360’s inspection technology is the only solution that compares data element accuracy as opposed to field level comparison.
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.
Where preferred, PRISYM 360 can be deployed onto customers’ premises, using Installation Qualification and Operational Qualification documents provided by PRISYM ID.
PRISYM 360’s integration with SAP helps ensure that accurate data is automatically used for labeling purposes. The use of standardized SAP technology, such as iDoc or web services via SAP Process Integration/Process Orchestration, means master data for labeling can be imported into PRISYM 360 for review, revisions and electronic approval. Transactional production data such as work order and batch data can be imported or referenced in real-time, with automated, unattended printing triggered from within the SAP environment ensuring that the right data is printed at exactly the right time.
PRISYM 360 includes integration with Oracle Enterprise Business Suite and Oracle Fusion applications using web services to provide real-time transfer of data from your key Oracle applications into PRISYM 360. PRISYM 360 can retrieve product information such as the GTIN (Global Trade Item Number) from Oracle Master Data Management and Agile PLM applications, and production data including lot and serial numbers from Oracle Pedigree and Serialization Manager (OPSM). Manufacturing and distribution processes can be adapted to ensure timely synchronization of data and accurate printing of labels.