HOME/02 Manufacturing Operations Management/Factova iPharmMES

Manufacturing Operations Management

Factova iPharmMES

The next-generation pharma & biotech digital hub that fully meets global regulations and enables AI-driven smart manufacturing

01 MES 02 iPharmMES 03 SPC 04 FDC 05 OCAP 06 RTS 07 RTD 08 RMS 09 AI Vision

WHY

Why Is It Needed?

Many pharma and biotech manufacturing sites face quality risks and operational inefficiencies due to tightening global regulations and the limits of managing complex processes.

01 Human error and weighing inaccuracies from handwritten batch records

02 Lack of data integrity and traceability at the level of global regulations (FDA 21 CFR Part 11) from raw material receipt to finished product shipment

03 Data silos and weak integration with key business systems such as ERP, LIMS, and QMS

04 Lack of real-time visibility into process changes, inventory, and bottlenecks

Factova iPharm MES embeds pharma- and biotech-specific processes and global GMP regulations into the solution, connecting every process into one flow and providing a safe, transparent, data-driven drug production environment.

KEY CAPABILITIES

Features of Factova iPharm MES

Builds order management, manufacturing procedure and record management, on-site inventory management, equipment management, system-to-system information integration, and equipment interfaces on a 21 CFR Part 11-based system.

01 Stability That Complies with Global Pharma Regulations

Complies with international MES standards, GMP, and 21 CFR Part 11 for a solution that supports global expansion without issue

02 Faster process preparation / Operational accuracy and data consistency / Management visibility

MBR-based potency calculation and automatic allocation of raw materials and supplies, with company-wide approval of production orders ERP integration automatically transmits input results and prevents material mis-loading Real-time monitoring of production results by line

03 Integration That Connects the Entire Factory

Integrated design spanning production, logistics, quality, and equipment, with operational layers unified from equipment control to business systems to data/AI

04 Heterogeneous Integration Across In-House and Third-Party Solutions

Supports integration of LG CNS solutions with the customer's third-party solutions, and a flexible, extensible architecture for future solution replacement or addition

MODULES

Functional Composition

Operation Layer

Production Orders Production Schedule Manufacturing Order Approval

Weighing Management Raw Material Weighing Material Dispensing

Production Results Remaining Quantity Management Labor Hours Raw Material Allocation WIP/Product Receipt Results Shipment Approval

Quality Management Test Request In-Process Inspection

MBR Management MBR Creation/Change Route Management

Equipment Management Equipment Use/Cleaning Electronic Logbook Management

Manufacturing/Packaging Records Process Work Records Equipment File Attachment

Dashboard Daily Process Production Report Lot Tracking

Control Layer

Historian DB

Real-Time Monitoring

Electronic Recorder

Equipment HMI

Equipment Controller

Scale/Measuring Instrument Integration

Delivers a data-driven smart factory through an integrated operating environment and heterogeneous system integration Flexible scalability supports sustainable digital transformation

IMPACT

Benefits

Paperless-based

Shop-floor productivity

25~30% improvement

Based on prevention of raw material mis-loading and automatic MBR-based potency calculation

Process defect rate

40~50% reduction

Real Impact of iPharm MES

Compliance operating cost

35% improvement

Based on ERP deployment

Data collection and review time

70~80% Reduced

With real-time equipment monitoring

Equipment downtime

20~30% reduction

Real Impact of iPharm MES

Audit readiness time

90% Reduced

Based on real-time ERP material allocation

Inventory turnover

15~20% Increased

Maximized productivity and operational efficiency

Minimized quality risk and losses

Regulatory compliance and lower management cost Global GMP compliance removes overseas regulatory risk, while MBR/ERP integration ensures data integrity and prevents human error

CUSTOMER VOICE

Voice of the Customer

"The No. 1 pharma & biotech MES, adopted by 30% of Korean pharmaceutical companies"

Operations Lead, Pharmaceutical Company H

WHY LG CNS

Why LG CNS

01 Rapid Initial Setup (Shorter Validation with a Global Standard GMP Package)

Provides pharma- and biotech-specific SOP (standard operating procedure) templates and standard functions optimized for global regulations (FDA, GMP, Data Integrity) as a pre-configured package.

Dramatically shortens build time and helps complete the validation process quickly.

02 Flexible Field Deployment (Zero-Downtime Cutover & Heterogeneous System Integration)

Based on field-proven zero-downtime cutover technology, the system is deployed reliably without stopping process lines that run 24 hours a day.

Works flexibly with a variety of existing on-site equipment and systems, including barcodes, RFID, weighing equipment, and third-party LIMS/QMS/ERP.

CASE STUDY

Innovation Without Production Stoppage: A Next-Generation AX (AI Transformation) Digital Journey Meeting Global GMP Standards at a Pharmaceutical Plant

Impact Story

Company / Plant Pharmaceutical production plant

Scope

First zero-downtime cutover in the pharma industry: replaced the system in stages over about 20 days without stopping the plant (Zero-Downtime) Dramatic reduction in human error: an operator-centered UI/UX that blocks progression to the next step if the weighed quantity does not match the target Real-time batch records and data integrity: fewer unnecessary manual entries, with transparency that supports audit trails and global regulations

REFERENCE

References

VIDEO Watch RESOURCES Materials CONTACT Contact Us

Move to top