아이디에스앤트러스트

Why idsTrust?

Why do you need GxP solution?

The need for GxP solutions is being emphasized in accordance with the strengthening of government policy regulations,
the change in the quality management paradigm, the difficulty of quality management standardization, and the increase in work.

Continued strengthening of government policy regulation
GMP Guidance publication (2015) - PIC/s, ICH, WHO, etc.Mandatory issuance of GMP certificate - 3-year renewal for all manufacturing plantsOccurrence of arbitrary manufacturing cases - Frequent reporting cases due to whistleblowing
A paradigm shift in quality management
Manufacturing process and quality management dual system - Expansion of introduction of QbD (Quality by Design)A paradigm shift in quality management in the pharmaceutical industry - to a preventive approach through continuous improvement
Quality management standardization difficulties and increased work
Lack of standardization of laboratory quality control workResponse to Ministry of Food and Drug Safety audit, increased workMore documents to manage due to increased production

Why idsTrust's GxP Solution?

idsTrust develops GMP software based on its own technology and is expanding its products to GLP and GCP.
We R&D, continuously upgrade, and supply S/W with high customer needs in each field.

Participation in the design of experts familiar with the pharmaceutical industry
idsTrust's GxP solution is software jointly developed with pharmaceutical field personnel. So our solutions have the features that are most needed in the field.
Thinking of ‘achievement of customer goals’ through software supply
If you just use the S/W carelessly, it will be difficult to achieve your goal. idsTrust guides you to accurately set goals and strategies, improves processes through training
Execute S/W update reflecting customer feedback and latest guidance
We provide an average of 2-3 updates per year. Customers can focus only on achieving their goals by using the latest S/W, and CSV change management is provided
Free connection cost for customers
ERP, account linking, and linking with other GxP systems are free of charge. It is idsTrust's principle to handle when customers need it.

GxP solutions that support industry compliance,
idsTrust presents high-quality solutions based on its own technology

MES(POP)
Point of Production System
LMS
Laboratory Information Management System
EDMS
Electronic Document Management System
QMS
Quality Management System
LMS
Learning Management System
ELN
Electronic Laboratory Notebook

POP(Point of Production System)

idsTrust's POP solution manages and shares real-time information generated during manufacturing and production.
This solution implements process production progress management and facility management, and contributes to quality stabilization and productivity improvement.

Key features

01Attendance-based manpower
management and report
Worker attendance management and
report (including KPI) statistics including non-production hours
02Bi-directional LIMS linkage
through inspection request
In-process inspection / sample collection
(management of the transferee) bi-directional linkage
03Convenience function and
performance accuracy improvement
Break time and simultaneous process management by department

Main functions

Production progress
Enables on-site monitoring and response by providing real-time information for each stage of the production process
Analysis report(1)
(Management of manpower by department)Provides various analysis indicators to identify trends and support decision-making
Analysis report(2)
(Work daily report)Provides various analysis indicators to identify trends and support decision-making
Analysis report(3)
(Facility efficiency analysis)Provides various analysis indicators to identify trends and support decision-making
Analysis report(4)
(Yield inquiry)Provides various analysis indicators to identify trends and support decision-making
Test request (administrator)
LIMS bi-directional linkage through process test request
Test request (terminal)
In-process inspection, product inspection request and judgment result
Convenience features
It is easy to calculate performance by considering break times when calculating manpower

Expected effects

Stabilization of quality and improvement of productivity
Manage and monitor the production process in real time.
Management of information generated during manufacturing and production
The performance of each process is managed as real-time data.
Reduction of process wait and proper cost
Shorter manufacturing lead times reduce waiting times.

LIMS(Laboratory Information Management System)

idsTrust's LIMS solution is a solution for managing the entire process of laboratory data and test results
in the GxP laboratory environment. SDMS and LAS modules provide electronic test records
through interlocking with automation devices and LES module.

Key features

01Compliance
CFR Part 11, audit trail suitable for global GMP regulations,
guaranteeing Data Integrity
02Flexibility and speed
Flexible process configuration and
fast response speed for large amounts of data
03Scalability
System linkage possible with ERP, MES, etc.,
application of multilingual language packs

Main functions

Test request
ERP linkage and self-test request creation function
Test result
The person in charge of each test item performs the test and inputs the result
Monitoring test plan
Test schedule creation and pass/fail judgment function through environment/water monitoring
Register for use
Use registration function when stock is received (automatic record of use registration when using LES stock)
Device inspection management
Device inspection function by creating a device inspection schedule
Shipment COA
Creation of shipping COA templates for each customer/country
LES implementation/review
Test result input and LES execution/review function
Audit Trail
Audit management for all activities occurring in LIMS (can be adjusted according to the plant environment)

Expected effects

Test process management and standardization
Strengthen quality by complying with US FDA cGMP regulations.
Automated test instrument data collection
Data is collected, stored, and processed
through automatic linkage with various devices.
Paperless / Enhancing Data Integrity
Data Integrity is strengthened
through Paperless for all data and history.

EDMS(Electronic Document Management System)

idsTrust's EDMS solution is a system that manages GxP documents from creation to disposal.
It provides overall GxP document management
from SOP / product standard / record / validation document.

Key features

01Integrated management
Integrated management of
life cycle for GMP documents
02Convenient creation and review
MS-Office based convenient writing and review,
document comparison function
03Output management/alarm
Output count and authority management,
document approval alarm

Main functions

My dashboard
My site, activity history, work history, and my documents can be checked at a glance
Site dashboard
At-a-glance understanding of each site’s document status,
workflow by type, and content information
Document library
All registered documents on the site can be identified at a glance
and new documents can be created
View document details
View document body, version history, ongoing workflow,
and document property information at a glance
Document approval history inquiry
Search detailed approval history information of document progress and completed workflow
Check-out/check-in
Enables MS Office to create/modify document body
Audit trail
Audit trail is possible by looking up all audits on the site by task type

Expected effects

Strengthen Data Integrity
Strengthen quality by complying with US FDA cGMP regulations.
Solve document management problems
You can manage the entire document life-cycle through online document management.
Improved convenience
It provides convenience in document creation, review, approval, and search processes.

QMS(Quality Management System)

idsTrust's QMS solution is a computerized system for overall quality management of GMP.
This solution takes real-time action on manufacturing and quality problem elements and manages quality through monitoring functions.

Key features

01Securing quality competitiveness
Automated establishment of quality process system
02Securing external competitiveness
Real-time inquiry of quality data enables rapid decision-making
03Securing external reliability
Eliminating the source of Data Integrity issues

Main functions

Dashboard
Visualize statistics about workflows, such as workflow processing status
Workflow Diagram
Define workflow steps and register and manage workflows in QMS
Choose a workflow type
Workflow can be executed by separating plant and event type
Workflow list
Fast and accurate workflow list search through various types of workflow search function
View workflow details
Check detailed workflow contents and provide useful convenience functions to users
Report
Provide data-based standard report of registered workflow
Audit Trail
Audit trail is possible by looking up all audits on the site by task type

Expected effects

Reduction of quality work cycle time
Quality-related turnaround time is reduced.
Data reliability improvement
It is easy to understand the linkage and progress of data work.
Preparing for FDA/EMA Inspection
It is possible to enhance document retention and
supplementation, and to manage document history.

LMS(Learning Management System)

idsTrust's LMS solution is a solution for managing overall training from GxP training preparation to progress and completion.
Real-time monitoring of training progress is possible, and history management is provided through electronic approval.

Key features

01High scalability
Interlocking with integrated systems such as EDMS,
multilingual language pack applied
02Strengthen Data Integrity
Strengthen Data Integrity
with paperless for all data
03Compliance with global GMP regulations
Compliance with CFR Part 11, Audit Trail
suitable for global GMP regulations

Main functions

View learning progress
View learning list and progress status for each learning
Learning details
You can check learning details, take lectures, and take quizzes
Register for learning
When using the system, select textbooks, evaluation methods, and certificates to register learning
Textbook registration
Textbook registration (direct upload of files and linkage with external systems possible)
Quiz registration
Quiz registration for evaluation (can add questions and handle multiple correct answers)
View list of approval requests
Query the progress of each person's requested approval
Group registration
You can view the list of registered groups and register new groups
User registration
LMS user registration by entering user information
(use activation period can be set)

Expected effects

Reduction of repetitive training man-hours
Training quality can be improved by reducing man-hours for repetitive training.
Quick response to inspection
Real-time data management enables rapid response during inspection.
Curriculum management/standardization
You can manage the entire learning process from preparation, progress, to completion.

ELN(Electronic Laboratory Notebook)

idsTrust's ELN is a solution that records and stores the research process and research results,
such as securing researchers' intellectual property rights, in the form of electronic documents.

Key features

01SDMS, LAS linkage
Original data can be automatically collected from experimental devices and used when writing research notes
02Substance/device management function
From warehousing registration of substances to disposal management, qualification evaluation of device
03Securing Data Integrity
Ensure Data Integrity through Audit Trail

Main functions

Dashboard
Provides experiment note status, shortcut, and schedule management function
Experiment request
Request a test by adding the person in charge of the experiment and sample information
Writing research notes
Provides registration function for writing research notes (materials, results: device parsing)
Assignment management
Provides task category management and task creation function
Stability test request
Provide stability test request function by specifying stability sample and storage information
Substance management
Provide material storage/use/move/divide function
Device use/inspection
Provide usage management according to device inspection plan
Audit trail
Audit management for all activities occurring in ELS
(can be adjusted according to the plant environment)

Expected effects

Strengthen Data Integrity
Reliability is guaranteed through point-in-time authentication and audit trails, and data integrity is strengthened.
Improving work efficiency through process standardization/digitization
Permanent data management is possible in electronic file format, and efficiency is improved through work automation.
Convenience such as device interlocking
It collects data through automatic device linkage and provides convenience in the approval process.

GxP Success Stories

GxP

Why idsTrust?

Why do you need GxP solution?

Why idsTrust's GxP Solution?

GxP solutions that support industry compliance, idsTrust presents high-quality solutions based on its own technology

POP(Point of Production System)

Key features

Main functions

Expected effects

LIMS(Laboratory Information Management System)

Key features

Main functions

Expected effects

EDMS(Electronic Document Management System)

Key features

Main functions

Expected effects

QMS(Quality Management System)

Key features

Main functions

Expected effects

LMS(Learning Management System)

Key features

Main functions

Expected effects

ELN(Electronic Laboratory Notebook)

Key features

Main functions

Expected effects

GxP solutions that support industry compliance,
idsTrust presents high-quality solutions based on its own technology