Consulting services to meet GxP CSV requirements
SERVICES
New
The PV consulting service has been started using the GxP-compatible
patent pending
) as the basic PV CSV method
This service is a PV System post-installation support service that provides consulting on the application of GVP/CSV reliability assurance and validation methods after production operation of PV Application System with AI functions, whose application to PV: Pharmacovigilance business is rapidly spreading recently.
patent pending
)” as the basic PV CSV method.
Providing consulting services to
In preparation of RFIs (Request for Information) and RFPs (Request for Proposals) required for upgrading or replacing the Global Safety Information System, we provide consulting services to support the preparation of RFIs/RFPs based on the Pharmacovigilance Business & Procedure.
Suggestions to improve safety adverse event case data
We provide consulting services for the analysis and proposal of operational improvements for the entry of adverse event case data in the Safety Information System, case evaluation, and individual case and aggregate reports to regulatory authorities.
In particular, we will introduce and support the introduction of systems and tools that are effective for automating Intake & Triage (including the use of AI) and improving operational efficiency, especially when cases are first obtained.
Provision of safety regulatory information by
We will keep track of the release status of safety regulatory information by regulatory authorities (PMDA/MHLW, FDA, EMA, MHRA, NMPA, MFDS, etc.) in each country in a timely manner and provide information on important regulatory changes.
Providing training sessions on ICH E2B (R2)/(R3) guidelines
We provide training sessions on guidelines and technical information on adverse event reporting issued by regulatory authorities in various countries.
Support for UAT (User Acceptance Test) scripting and execution
We provide technical support for UAT Script creation and UAT execution, which are necessary for UAT (User Acceptance Test) when introducing or upgrading the safety information processing system or SAP S4/HANA.
SAP ERP System (S4/HANA, Solution Meager, MDG) GxP CSV
Provides optimization consultation for GxP CSV QMS compliance when introducing and upgrading SAP S4/HANA.
Support for PMDA EDI/GW connection testing
The validity period of the “Digital Certificates” for encryption set in the EDI Gateway (EDI GW) used for electronic reporting of individual adverse events to PMDA is 25 months (2 years and 1 month). We provide the procedure to MEDIS-DC for switching the electronic certificate and technical support during EDI connection test with PMDA.
