Online Package Insert Authoring System
Create, review, manage, and convert package insert documents in a single web-based platform.Designed for medical devices and in vitro diagnostic products, PackinStar streamlines the entire document creation workflow.
Create Package Insert PDFs Online
Supports in vitro diagnostic products and medical devices.Template-based authoring ensures consistent layouts regardless of the operator.
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Convert to Multiple Document Formats
Generate SGML simultaneously when creating PDF files.Structured data can be managed and reused for other applications.
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Comprehensive Document Management
Manage document versions together with complete revision histories.
Learn More →Create Package Insert PDFs Online
Create package insert PDF documents for in vitro diagnostic products and medical devices directly through a web browser.Template-based authoring ensures consistent layouts regardless of the operator.
- Intuitive Editing Interface
- An intuitive user interface simplifies data entry for package insert PDFs.Line spacing, character spacing, and special characters required for PDF publishing can be configured easily.
- Template-Based Layout Management
- Predefined layout templates and heading structures help maintain consistent document formatting across users.Document layouts can be updated by changing templates.Templates can be customized for each company, and multiple templates can be managed within a single organization.
- Support for Multiple Document Types
- Supports package inserts for in vitro diagnostic products as well as medical devices and prescription medicines.English-language documents are also supported.
Multi-Format Document Conversion
- Simultaneous Output to Multiple Formats
- Generate HTML and SGML for PMDA submission simultaneously.Additional PDF formats can also be created from the same source data.
- Data Reuse and Management
- Manage entered content as structured data by section, enabling extraction, bulk replacement, and efficient reuse.The data can also be integrated with full-text search systems and other applications.
Comprehensive Management Features
- Version Control
- Store document data submitted for review in the system.Record revision dates, revision reasons, and modified sections.
- Review Management
- Reviewers can access and review documents directly through the web.The system records reviewers, review dates, request dates, review results, and comments.Previous versions are retained for comparison, making it easy to restore an earlier revision when necessary.
- Image Management
- Manage images for each document.PDF images can be registered for use in PDF composition.
- Management of External Documents
- Documents that are not composed within the system can also be registered as PDF files and managed through the same version control process.
Additional Features
Document List View
Display registered documents in a list and quickly find information using filtering and sorting options.
Imposition
Create print imposition layouts directly in the web browser. Page size, orientation, and other print settings can be adjusted as needed.
User Management
Manage user accounts, access permissions, and login passwords.
Contact Us for an Online Consultation
Whether you are planning to create and manage package insert PDF and SGML documents in-house, or are considering our document creation outsourcing service, we are here to help.
Our team will be happy to explain the available solutions and help you choose the approach that best fits your workflow.
We also welcome inquiries about PackinStar, product documentation, and requests for additional information.
Document & Package Insert Management
Explore solutions that streamline the creation and management of package inserts and related documents.
