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  6. Are you able to manage the pharmaceutical and medical device package inserts in-house?

Are you able to manage the pharmaceutical and medical device package inserts in-house?

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last updated:Jan 09, 2025

ネクストソリューション
ネクストソリューション
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A system that contributes to reducing the effort and mistakes involved in creating and revising pharmaceutical and medical device package inserts. Managed with XML one-source! *Examples of achievements available.

The attached documents that are believed to be thoroughly managed within the company are actually also managed by external vendors (printing and production companies). Is it possible that the PDFs of the attached documents managed by pharmaceutical and medical device manufacturers are in a format that cannot be edited, such as images, making it impossible for your company to make corrections? To quickly provide information even during urgent revisions, it is necessary to mitigate external risks and create an environment where your company can respond. 'PMDOC X' is a system that contributes to reducing the effort and mistakes involved in the creation and revision of pharmaceutical and medical device attached documents. It manages pharmaceutical and medical device information in a single XML source and enables the realization of six related formats with just one button. 【Features】 - Contributes to reducing the man-hours and mistakes in revision work and maintaining consistency between documents. - Allows for importing/exporting Word documents using templates prepared in advance by our company. - Enables easy realization of a clean layout through automatic typesetting. - Allows for setting up document approval routes according to your company's operational methods. *Examples of actual implementations are available in PDF format. *For more details, please refer to the PDF materials or feel free to contact us.

    Document and Data Management
PMDOC

Are you able to manage the pharmaceutical and medical device package inserts in-house?

PMDOC X-80.jpg
PMDOC X-80.jpg
  • Related Link - https://www.nextsolution.co.jp/products/pmdoc/

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basic information

**Main Features** ■ Outputs in 6 different formats <Available 6 formats> 1. XML…For PMDA submission 2. PDF…For PMDA submission / For printing (PDF/X-1a) 3. HTML…For PMDA display confirmation / For website publication 4. Text file 5. (*)Word…Single-column template (company specified format) / *Packaging label / *Notification document / *Interview form 6. *InDesign…For printing * Optional feature. ■ Importing / Exporting Word Importing and exporting Word documents is possible using templates prepared in advance by our company. ■ Automatic typesetting with one button Automatic typesetting allows for the efficient creation of beautifully unified layouts that are not affected by the editor's skills. ■ Detailed old-new comparison Assists in approval tasks with detailed old-new comparisons before and after revisions. It clearly displays comparisons not only of text but also of images and paragraphs. ■ Approval workflow Flexible approval route settings tailored to operations aim to improve the efficiency of approval tasks.

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P4

※It may vary depending on customization, so please feel free to contact us.

Applications/Examples of results

*For examples of achievements, please download the PDF or contact us.*

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Pharmaceuticals and Medical Devices Package Insert Creation Management System PMDOC X

Pharmaceuticals and Medical Devices Package Insert Creation Management System PMDOC X

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Next Solution Pharmaceutical and Medical Device Package Insert Creation Management System PMDOC X (Pamdoc X) Case Examples

Next Solution Pharmaceutical and Medical Device Package Insert Creation Management System PMDOC X (Pamdoc X) Case Examples

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Pharmaceuticals and Medical Devices Package Insert Creation Management System Online Seminar 'page2022'

Pharmaceuticals and Medical Devices Package Insert Creation Management System "PMDOC X" Online Seminar 'page2022' [January 31, 2022 (Monday) - February 10, 2022 (Thursday)]

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"PMDOC X" is a system that contributes to reducing the effort and mistakes involved in creating and revising pharmaceutical and medical device package inserts. It manages pharmaceutical and medical device information in a single XML source and can generate six types of formats for various purposes, such as submission to the PMDA or for printing, with the push of a button. It allows for easy creation of XML and PDF documents compliant with the new pharmaceutical labeling guidelines, and revisions are automatically reflected in each document, thereby reducing the burden of revision work. 【Features】 ■ Contributes to reducing labor and mistakes in revision work and maintaining consistency between documents ■ Allows for importing/exporting Word documents using templates prepared in advance by our company ■ Achieves a clean layout easily through automatic typesetting ■ Enables setting of document approval routes according to your company's operational methods In the online seminar, we will clearly introduce the functions and benefits of implementation, along with case studies and demonstrations.

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As the digitization of documents progresses, XML, which is highly versatile and well-suited for the internet, is being utilized in various fields. Since our establishment, we have specialized in XML/SGML-related technologies, providing professional services to support the efficiency and standardization of technical manuals and the creation and management of official documents for various industries, including government agencies, pharmaceuticals, finance, and manufacturing.

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