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Digitization

The future in our hands

CPI Pharma MES – The Digital Factory

Connected Pharmaceutic Industry

Smart Factories are emerging

By applying modern digital technologies, your pharmaceutical production and all associated systems including logistics are being taken to the next level of efficiency and intelligence.

CPI Pharma MES is the core system that will take your pharmaceutical production to this next level of efficiency and intelligence by digitization.

With its gateways, CPI Pharma MES is an information hub between management systems (e.g. ERP), pharmaceutic batch record planning system, production and warehouse automation, logistics and adjacent systems like document management systems (DMS) or laboratory information and management systems (LIMS).

Electronic batch record functionality

CPI Pharma MES electronic batch record functionality (eBR) will replace traditional paper-based batch records in your production and by this dramatically increase your pharmaceutic production efficiency and eliminate the need for long-term storage of huge amounts of paper by digitized long-term eBR data storage, e. g. using digital DMS.

CPI Pharma MES eBR can start very lean with focus on operator task guidance including SOP provision and protocolling and can then be step-wise extended up to complete connection of all your systems.

Weighing & Dispensing

This module enables to precisely weigh and dispense your input material for production and digitally record the complete operation.

Track & Trace

Realtime Track & Trace in your production will be enabled with SODA functionality (Single Object Data Acquisition) down to the granularity to each individual material container, and GS1-compliant Track & Trace for secondary packaging and external logistic will be supported, including country-specific regulations.

Management Dashboards

Standardized communication between the systems of your pharmaceutic production and CPI Pharma MES make it possible to generate “smart data” from countless pieces of information. This cross-production intelligence provides an up-to-date view of the most important KPIs, e.g. OEE in CPI Pharma MES management dashboards and thus provides transparency and enables production optimizations.

 

Your Benefit

  • Increase in efficiency, transparency and quality by digitalization

  • Paperless electronic Batch Record documentation by digitization

  • Traceability and permanent data availability

  • Management cockpit for analytics and continuous improvements

  • Complete connectivity of all your systems (internet-of-things)

CPI Pharma MES modules and features at a glance

CPI CORE Module
  •  Adaptable web user interface

  •  Site specific configuration

  •  GMP and 21 CFR Part 11 compliance, e.g. Audit Trail, users and roles management

  •  Language setting

  •  CPI database and connectivity core

Batch & Order Management
  • Master Batch Record (MBR)
  • Electronic Batch Record (eBR), digitization of previous paper-based pharma batch production
  • Weighing & Dispensing (W&D)
  • Material Management
  • Digital long-term archiving of eBR data replacing paper-based archives
  • Fast access to archived eBR data
Line Manager & Connectivity Modules
  • Realtime data exchange with machines and workplaces, incl. format parameters
  • Modules for CPI connectivity with IT Systems, e.g. ERP, DMS, Warehouse
Energy Monitoring & Management
  • Collecting and monitoring of energy and media consumption data
  • Planning and control of energy and media supply
Intelligence & Analytics
  • Dashboards & Cockpits for Management and Operation
  • Monitoring of KPIs, e.g. OEE, performance gaps
  • OEE optimization features incl. AI features
  • Maximum production and data transparency
GS1 Track & Trace Level 3
  • Level 3 of GS1 compliant pharma track & trace for secondary packaging
  • Serialization & aggregation
  • Connnections to L2 and L1 production systems
  • Connection to L4 IT systems
  • Compliance to country specific regulations (EU, US, MEA, etc.)
  • Warehouse Rework
SODA Production Track & Trace
  • Single Object Data Acquisition (SODA)
  • Tracking of material and product ingredients for every single container
  • Tracking of production steps for each container
  • Complete transparency and traceability in your production
Equipment Management
  • Manages correct equipment usage at production workplaces
  • Manages equipments’ cleaning, setup and calibration
  • Double-checks equipments’ readiness for usage
  • Tracking of equipment usage within production batches
Operator Qualification Management
  • Manages operator qualification & training schedule
  • Planning & tracking of trainings
  • Double-check operators’ qualification against required qualification for each production machine and workplace during batch operation

The Digital Factory Software Suite

The Digital Factory Software Suite guarantees an increase in efficiency and quality in the processes as well as permanent data availability. Enabling paperless production using electronic batch records (eBR) with fully digitized Q-Checks and a management cockpit ensure continuous improvement on the shop floor.

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