팝업레이어 알림

팝업레이어 알림이 없습니다.

Best Partner Your Business, Pharmsoft

The benefit of customers,
the benefit of partners,
and our profit.

COMPANY

Company Info.

We are an IT company that develops,
builds, and supports quality IT systems in the GxP area.

We were established in 2014 to develop a global quality IT system in line with
the Ministry of Food and Drug Safety's PIC/S subscription.
We continue to grow every year through new product development and product upgrades.
Our products are being developed in 8 categories (LIMS, ELN, LAS, QMS, EDMS, PQRS, LMS),
and all of them are implemented in the same framework environment
to maximize synergy through optimal interlocking between products.
Our program is being operated about 80 systems in 40 research institutes and factories pruducing drug,
raw material, biomedicine, medical device. It is now extended to the new product development process
and ISO operating work of the pharmaceutical company's headquarters.
Through continuous efforts, we want to grow into a leading software company in the regulatory-based industry.

OUR PARTNERSHIP

Partnership

BUSINESS

Business Area

  • Building a laboratory system

  • Establishment of quality
    assurance system

  • Atypical work management

Building a laboratory system

PharmLIMS/ELN/LAS/QMS

By building a LIMS system in the laboratory,, overall IT-ization of laboratory work is implemented. We systematize the entire process from test request to receipt, order, result review and approval, and management of samples, inventories such as reagents/standards, columns and equipment, and stability tests of pharmaceutical companies.

The ELN and LAS systems systemize the calculation sheets, logbooks and data that are not managed by the LIMS system. By automatically uploading the outputs and data of all test devices to the server and recording the necessary data in the calculation sheet and logbooks, you can dramatically reduce the number of post-test tasks and actively respond to Data Integrity issues. With the establishment of a QMS system linkage, it is possible to systemize lab inspection, OOS/OOT and to make paperless labs.

Establishment of quality assurance system

PharmEDMS/LMS/QMS/PQRS

With the introduction of PharmEDMS, we achieve breakthrough quality improvement and cost reduction by optimizing the process of preparing, reviewing, approval, training, release, distribution and collection of regulatory documents such as standards and SOPs, which are the basis of work. In particular, it is possible to perfectly respond to document-oriented due diligence by fundamentally preventing omission of work through linkage with the Education Management System (LMS).

While EDMS systematizes regulatory documents, PharmQMS systematizes the process of writing implementation documents. Real-time document creation, automatic list management and one-click tracking management are implemented by systematizing all documents and data for major quality assurance tasks such as management of change, deviation, CAPA, consumer complaints, validation and supplier evaluation. By using the Tablet PC to create various documents at the production site, it is possible to implement Paperless in connection with the MES system.

The Product Quality Assessment System (PQRS) collects all IT-based quality data and supports automatic report creation. It automatically collects data on all items such as production history, process yield, process inspection, test results, input raw materials, changes, deviations, validation status, and stability test. After automatically filling the data in the Excel form for each company, the necessary table forms and graphs are directly written in a word file. The person in charge writes a remark and sends the product quality evaluation report, and reviewers and approvers can also complete it through electronic signatures.

Atypical work management

PharmWFMS, Work Flow Management System, Work Flow Management System

PharmWFMS is a system that allows you to set up your company's various tasks in a flowchart manner. The administrator can set it infinitely, and it runs according to the set sequence. It is used as a system to support the company's backbone system with excellent flexibility and is mainly used to support unstructured work and project-like work.

By applying it to the new product development process, it intuitively manages each stage from product review to release, communicating in real time with all relevant departments, and providing real-time statistics over several years.

By applying to ISO operation and project-related tasks, it can satisfy various tasks of each organization and maximize management efficiency.

PRODUCT

Products

PharmSolution LIMS

Laboratory Information Management System

­

The Laboratory Information Management System provides systematic support for all laboratory tasks. (Laboratories of raw materials/finished products GMP plants, laboratories of laboratories, laboratories of consignment agencies, etc)

Ensure that laboratory work is carried out in accordance with the regulations, GMP regulations, and guidelines of the Ministry of Food and Drug Safety.
You can automatically print out a request for an experiment, an experimental instruction, an experimental journal, an experimental report, and related labels.

PharmSolution QMS

Quality Management System

­

It systematically supports the overall quality assurance work of the GMP factory.
Change management, Deviation, Out of Specification, CAPA, Complaint management, Audit, Validation, Qualification, Calibration etc. as a system according to company-specific SOPs.

Each itemized report and form can be registered as an Office document (Excel, Word). 100% Work Flow settings allow you to intuitively understand work flow and track/statistics by management index.

PharmSolution EDMS

Electronic Document Management System

­

It helps you organically manage the process of creating, reviewing, approving, and distributing, publishing, and collecting documents in accordance with GMP regulations. (Every page is automatically assigned a unique number when printing after document approval, so you can track it.)
Documents are available in real-time based on lookup/view/output permissions. Additionally, it supports the issuance and management of manufacturing/packaging records and experimental records.

PharmSolution WFMS

Work Flow Management System

­

It facilitates the company's long-term projects and complex tasks involving multiple teams.
Intuitive visibility into your workflow.
Meet the limited aspects of groupware or electronic payments and enable historical management and statistical analysis. (Approval and document upload in the system / Tracking and statistics by management index)

Ex) New product development, ISO operation (corruption prevention system), internal accounting standards within the company, additional processes of manufacturers, etc

PharmSolution PQRS

Product Quality Review System

­

It supports the preparation of product quality assessment reports for each item in a form that meets GMP guidelines.

A report can be created by automatically linking information such as LIMS, QMS, etc. of the item (statistical accumulation information, etc.) through setting.

PharmSolution LMS

Learning Management System

­

It supports systematic management of job description preparation, new employee education, annual education, regular education by department, legal education, and examiner education.

Education history and training history of all education can be inquired, education can be evaluated through online tests (objective and subjective), and re-education processes for absentees can be set.

PharmSolution ELN

Electronic Laboratory Notebook

­

Supports the automatic creation of test logs by item/item (excel format)

It is possible to automatically record used information such as test equipment, standard products, reagents, etc.
Automatic creation/LAS linkage/direct input can be set for each item and is confirmed by electronic signature.

PharmSolution LAS

Laboratory Automatic System

­

The report automatically registers and extracts data from the laboratory's test equipment (LC, GC, etc.) to the LAS, and automatically completes the test log when it is sent to the Electronic Laboratory Notebook (ELN)

Depending on the test device, selectively determine the interlocking method. (Upload RS232 communication/USB/PDF documents, etc.)

PharmSolution Tablet

­

­

Test information can be entered in real time through the tablet.
Helps enable paperless laboratories.

PHARM PACKAGE

Pharm Package

Competitiveness

Comparison with domestic softwares

  • Packaged product

    High quality, proven functions, many options, easy upgrades

  • Consulting skills

    Separation of consulting team, overall understanding of GxP, third-party cases

  • Project skills

    Stable performance according to standard implementation methodology

Comparison with global softwares

  • Convenience of use

    Screen configuration that users can easily search/enter

  • Various functions

    Provides various functions that help in real work

  • Upgrade

    Upgrade support available every 1-2 months

  • Establishing/Operation Costs

    Relative advantage of building cost and operating cost

Operation/Maintenance Aspects

  • Maintenance

    Operation of a help page dedicated to maintenance.
    Operation of a maintenance department

  • Change Control

    Support for CSV change control management

  • Extendability

    Package function extension applied sequentially in various ways

product composition

QMS

  • Quality Assurance

  • Process

  • Statistical Analysis

EDMS

  • Document conversion

  • Document structure

  • Document publication

PQRS

  • Document form semi-automatic setting.

  • Data interworking

  • Document preparation

LMS

  • Job management

  • Education management

  • Individual history management

LIMS

  • Test report

  • Test records

  • Statistical analysis

ELN

  • Form setting

  • Log-Book

  • Equipment interworking

LAS

  • Device connection

  • Item extraction

  • Data transfer

Tablet ELN

  • Test records log

  • Camera/Photo

  • Data transfer

  • Master Data Management

  • System & Configuration Management

  • Windows

  • MS SQL Server

  • 게시물이 없습니다.

Archives

Download Pharmsoft materials.

more