d-Solutions List of Products and Services

**Overview of System Implementation Support Services for Pharmaceuticals and Medical Products** ● Current Situation Survey / Hearing / Proposal Investigation of the current situation, analysis, and issue extraction Hearing customer requirements Verification of compliance validity Preparation of RFP, product selection, supplier selection, audits ● Requirement Definition / Basic Design / Compliance Validity Preparation of requirement definition documents Preparation of basic design documents considering functionality, operation, and scalability Verification of compliance validity regarding requirements and system functions ● Detailed Design / Coding / Unit and Integration Testing (Manufacturing) Creation of detailed design documents based on the basic design documents Coding according to the detailed design documents Conducting unit and integration tests for each function, evaluating results, and making improvements Conducting QC and preparing essential documents according to quality management standards ● Comprehensive Testing / Environment Setup / Data Migration Preparation of a test plan (including IQ and OQ elements) followed by comprehensive testing If there is migration data, conducting migration tests in advance and migrating the data Conducting QC and preparing essential documents according to quality management standards ● Training / Support / Operation and Maintenance Conducting training (for users/administrators) according to the education program and maintaining training records Maintenance services (subject to consultation)

• Other Software

**Overview of Consulting Services for Pharmaceuticals and Medical Products** ● Business Consulting for Pharmaceutical Companies and Research Institutions We conduct investigations and analyses of business processes aimed at compliance with regulatory requirements, improving operational productivity, and maintaining and enhancing quality. We propose measures to address gaps in organization, structure and roles, business flows, and quality management, and support the stabilization of new processes after improvements. ● System Consulting for Pharmaceutical Companies and Research Institutions (Regarding System Evaluation and Implementation) We investigate and analyze the computer systems used in operations related to regulatory requirements to ensure the integrity, reliability, and trustworthiness of the systems, as well as the authenticity, readability, and maintainability of the electronic data handled. We provide proposals for measures to address gaps and risks that should be implemented by pharmaceutical companies and research institutions. ● Consulting for System Suppliers (Regarding Requirements for Service Suppliers to Pharmaceuticals and Medical Companies) We conduct investigations and provide guidance for improving the quality of systems required by GXP and for the preservation of processes and essential documents and records related to supplier investigations. Additionally, we participate in supplier investigations from the supplier's perspective, addressing questions and comments.

• Other Software

In the process of research and development of pharmaceuticals and post-marketing, computer systems are utilized in compliance with regulatory requirements at each stage of drug development to ensure consistently high quality through computer system validation. - Requirements Definition and Basic Design Phase Participate in meetings for requirements definition, review the User Requirements Specification (URS) and confirm business and regulatory requirements, and create a Computer System Validation (CSV) plan. Examine basic functions, configuration details, and necessary functions for business and regulation, and create a functional specification document. Conduct a risk assessment to determine the validation level based on risk levels and create a traceability matrix. - Detailed Design and Development Phase Create an Installation Qualification (IQ) plan and a list of verification items, and obtain approval. Review design and functional specification documents, create an Operational Qualification (OQ) plan, and obtain approval. Review business flow and operational design, create a Performance Qualification (PQ) plan, and obtain approval. - Verification and Reporting Phase Support OQ activities as a tester and test leader, create and obtain approval for the OQ report. Support PQ execution, create and obtain approval for the PQ report. Organize validation-related documents and records, and create a comprehensive CSV report based on the results.

• Other Software

"PV-Connect Cloud Services" is a SaaS application service for our product "PV-Connect (Safety Information Solution)." d-Solutions began offering the SaaS application service for our product PV-Connect (Safety Information Collection Solution) in July 2024. This service allows for semi-customization based on the scale of use, increasing options available. Users can now utilize the service without purchasing licenses or hardware, making it possible to try it out or start small. This service also includes a trial environment usage service for those considering system implementation. During the conceptual phase of system implementation, trialing the target system (the system being considered for implementation) serves as valuable decision-making material. Additionally, it can be used to organize requirements for the system and confirm constraints. 【Main Service Structure】 ■Trial Use (Trial Environment) ■Standard (Verification Environment, Production Environment) ■Completeness (Verification Environment, Production Environment, Training Environment) *For more details, please refer to the related links or feel free to contact us.

• Other Software

"d-PageNumbering for PDF" is an Adobe Acrobat plugin software that inserts page numbers, dates, file paths, and file names into the headers and footers of PDF documents. It allows you to output page numbers and dates in any format, with options for specifying fonts, sizes, and colors. It can be used when you want to insert page numbers and text in a uniform format into existing PDF documents or PDF documents created by merging multiple documents. 【Features】 ■ You can insert page numbers, total page counts, and dates in any format, and it is also possible to insert the document's file path. ■ You can specify fonts, sizes, and colors for output, and it is possible to specify a range for output, such as from page X to page Y. ■ The output position can be specified as header, footer, left-aligned, center-aligned, or right-aligned, and you can also specify any position. *For more details, please download the PDF or feel free to contact us.

• Other Software

"d-LinkMaker for PDF" is an Adobe Acrobat plugin software that allows you to easily create links, file links, attachment links, bookmarks, and destinations within PDF documents. You can efficiently set link information, bookmark information, and destination information in existing PDF files. By using the search function in conjunction, you can perform accurate and efficient link creation tasks. Additionally, you can pre-set link information and add links through text selection, rectangles, or image selection, and you can check, modify, or delete links from the link list screen. [Convenience (Partial)] ■ When you want to add a link to a target string using text search (you can specify the color of the text and the position of the link destination as desired) ■ When you want to add a link to a selected image ■ When you want to add arbitrary rectangle links to image-based PDF files ■ When you want to check scattered link information in a list *For more details, please download the PDF or feel free to contact us.

• Other Software

The "d-FormChecker for PDF" is a tool developed to ensure that PDFs generated can be viewed correctly in different OS and language environments. It supports UNICODE and includes various features such as bulk font checks. Additionally, it accommodates both vertical and horizontal writing. It is useful for final checks after converting documents to PDF and for checking PDFs used in information exchange with overseas offices. 【Convenience (partial)】 ■ Pre-check for application documents and reports submitted to public institutions ■ Final check after converting target documents to PDF ■ Since information published on websites is expected to be accessed by an unspecified number of users, it checks to ensure that users with different access environments can view it. *For more details, please download the PDF or feel free to contact us.

• Other IT tools

"d-FormChecker Pro" is a product that checks for usage restrictions in formats such as fonts, margins, and styles according to internal regulations, submission destinations (regulatory authorities, clients), and the purpose of submitted documents. It displays violations found in documents and materials created with Microsoft Word/Excel. Key features include text conversion, clear all highlights, batch check functionality, font checks, and various other features. Please feel free to contact us if you have any inquiries. [Main Features (Partial)] ■ Toolbar display function ■ Setting of format check conditions ■ Setting of available fonts ■ Setting of available page configurations ■ Font check *For more details, please download the PDF or feel free to contact us.

• Other Software

The "Electronic Detailed Investigation Form (eSS)" is an electronic version (PDF) of the detailed investigation form used to request a thorough investigation of safety information. By digitizing it, we provide a solution for improving the efficiency of detailed investigations, including the convenience of creating forms and implementing logical checks during input. When used as an option for our product "Adverse Event Collection and Management System (AE-Connect)," it allows for linking with electronic contact forms, enabling centralized management of the status of detailed investigation form requests, thereby contributing to smooth safety management operations. Additionally, it adopts a standard electronic file format (PDF), eliminating the need for specific applications. 【Features】 For busy healthcare professionals: - No new infrastructure is needed as it utilizes widely adopted mobile devices (iPhone, iPad, Note-PC, etc.) - Reporting can be done from anywhere (while walking, during breaks, from home, while eating, etc.) - The use of a standard electronic file format (PDF) means no specific systems are required - Input is facilitated through various selection methods (calendar input for dates, dropdown selections, checkboxes, radio buttons, etc.), making responses easy *For more details, please download the PDF or feel free to contact us.

• Other contract services

LT-Connect is a solution focused on the collection and evaluation of literature information, which is one of the safety measures in pharmaceutical operations. It screens literature information obtained from SDI service companies (primary evaluation, etc.), and if additional information is needed for secondary evaluation or if a detailed investigation is required, this function allows for investigation requests to be sent to Medical Representatives (MRs). MRs can receive requests and respond with investigation results using smartphones or iPads. The Pharmacovigilance (PV) department collects investigation results in a timely manner and determines the necessity of research reports (secondary evaluation, etc.). Additionally, if there are events that should be processed as individual reports based on literature information or detailed investigation results, they are handled as individual reports of adverse effects. This function retains all obtained literature information, screening and evaluation results, and records of MR activities related to literature information investigations, and it can share information with safety information management systems (such as Argus, ARIS, Persiv, etc.) for information that needs to be reported to regulatory authorities. It also centrally manages the collected literature information (SDI) along with PDFs.

• Sales and production cost management system for food and pharmaceutical manufacturing industries

AC-Connect: A new standard for collecting adverse event information that balances accuracy and speed, making adverse event reporting smarter. 'AE-Connect' is a system that allows medical representatives (MRs) to quickly and reliably report safety information obtained to the pharmacovigilance (PV) department using a smartphone. When an MR obtains information about an adverse event at a facility, they can input the necessary information for the initial report through the web browser on their mobile device. The initial report from the MR is immediately displayed in a list on the management screen of the safety management department (PV department), where detailed information can be confirmed. Additionally, inquiries to the MR can be made as needed. Furthermore, new information can be added as supplementary information to previously reported data. 【Features】 ■ Streamlines the time of busy MRs ■ Maintains the accuracy of reported information, allowing the PV department to receive it in a normalized and structured state through input validation features ■ Achieves data linkage with other systems using an industry-standard (E2B) interface (XML linkage) ■ Retains activity records between MRs and PV, as well as audit trails of collected data, ensuring compliance with regulations ■ Allows files to be attached to contact report information, enabling centralized management of information related to the contact report *Please feel free to contact us.

• Sales and production cost management system for food and pharmaceutical manufacturing industries

"MP-Connect" is a web solution that allows healthcare professionals to quickly communicate adverse drug reaction information directly to pharmaceutical companies in the field of drug use (medical institutions, pharmacies, research institutions). When healthcare professionals obtain information about adverse events in a medical setting, they can input the necessary information for the initial report through a web browser, enabling immediate reporting. Pharmaceutical companies operating AE-Connect can view the information reported by healthcare professionals about adverse events on the AE-Connect reception screen, where detailed information can be confirmed. 【Convenient for the following situations】 ■ Secure and easy user registration using an email address is possible. ■ Healthcare professionals do not need to carry a computer or adverse event reporting forms at all times. ■ Adverse event information can be registered with simple operations, so no special training is required. ■ Other files can also be attached to adverse event information. ■ Photos or PDFs taken with devices equipped with camera functions can be attached to adverse event information. ■ Reporting can be done regardless of location. *For more details, please download the PDF or feel free to contact us.

• Pharmaceutical and cosmetic factory software and systems