Introduction

Offered by CCE Software, India and Novatek International, Canada for Pharmaceutical Manufacturing Industries

Company Introduction
CCE Software (P) Ltd, India
CCE Software focuses on business solutions based on intelligent use of the technology. Our core service area include: Application Development (Client Server / Workflow) Web Development E-Business - Consulting Business Process consulting Project Management Professional Service

NovaTek International, Canada

Novatek is known worldwide for leadership in pioneering 21 CFR Part 11 compliant
solutions for the entire product life cycle of healthcare quality operations. Novatek provides solutions for manufacturing, packaging, and quality assurance and control.

What is an ERP?
ERP is a business process management solution that provides organizations with consolidated inventory, manufacturing, warehousing, financials, multi-site reporting and relationship and knowledge management capabilities. Employees, customers and partners are provided with access to information across the entire enterprise value chain.

Why Do I need an ERP system?

Clients commonly realize the following benefits from ERP: Increased operational effectiveness & productivity Timely and targeted information feedback system for decision support Efficient inventory management

Improved Planning
Improved customer service

Salient Features Designed and Developed to follow cGAMP guidelines 21 CFR Part11 Compliant
21 CFR Part 11 compliant

Electronic Batch Record Management (EBRM) Recipe Management Regulated FIFO & FEFO concepts of inventory control Multi-location warehouse Management System Seamless integration to Nova-LIMS

- Process Flow
Master Recipe Workcentre Hierarchy Shop Floor In-Process Control cGMP
guidelines

Computer Aided Manufacturing

Sales Forecast

c Pa ka

Process Flow

Sales Forecast

Production Planning & Control

Scheduling

Production

Stores Warehouse
(Finished Products)

ng gi

Dispatch

Routing

Capacity Planning

Inspection Plan

Inspection Record

Finished Goods

Audit Report cGMP

cGMP guidelines

BOM

Materials Management (Inventory)

Quality Assurance

Warehouse Management System

Raw Material Qurantine,Approved, Rejected

Purchase Management

Payable

Finance Management Costing

Receivable

Modules
Manufacturing

Material Management Quality Control Nova-LIMS

Central Database

Purchase

Sales

Finance

Manufacturing Module - some key features

Create and manage Production BOMs Production Forecasting Consumption Journal Posting Output Journal Posting Automated Material Plan generation Production Order Management

Manufacturing Module - some key features

Simulating Production BOMs Recurring Journals Recurring Planing Worksheets Routing definition

Capacity Requirement Planning

Capacity Journals

Manufacturing Module
Manufacturing Module BOM Creation Reports

Production Forecast

Consumption Journal

Planned Production Order

Material Management Module - some key features

Item types - Regular items and Non stock items Addresses both GMP and non-GMP items Managing both Value and Quantity based Registers Facility to define and manage multiple warehouse locations Multiple levels of BOM Detailed statistics based on locations and periods Stock Reconciliation At warehouse / item(s) level

Material Management Module - some key features

Provision to effect changes to item valuation

Alerts and notifications on Shelf Life

Storage Differentiations for Quarantine / Approved / Rejected items. Item tracking based on Expiry dates and Serial No. / Lot numbers Bar code interface integration Batch posting of journals

Material Management Module

Material Management Module Reports

Item maintenance

Item Journals

Transfer Order

Revaluation Journals

An example for cGAMP based Process flow Material Management

$ $
$

Manufacturing

Warehouse

Purchasing

Receiving

Quanrantine Inventory

Re-Engineer

Quality Assurance

Rejected Inventory

Return to Vendor

Approved Inventory Dispose

Shipping
$

Manufacturing

Warehouse

Customer Sale

Purchase Module - some key features

Purchase Journals Payment Journals Requisition Worksheets

Quotes
Blanket Purchase Orders Purchase Orders

Invoice handling
Return Management

Purchase Module
Purchase Module

Purchase Journal

Reports

Purchase Order

Purchase Invoice

Return Order

Sales Module - some key features

Customer Management Sales Journals Cash Receipt Journals Sales Quotes

Blanket Sales Orders

Sales Orders

Invoice Management
Return Order Handling

Sales and Distribution

Sales Module Reports

Sales Journal

Sales Order

Invoice

Order Returns

Finance Module - some key features

Chart Of Account Definition

Bank Account Management

Budget planning

Multi Dimensional Analysis

General Journals Recurring Journals Bank Account Reconciliation Posting Groups Setup

Finance Module
Finance Module Bank Accounts Reports

Accounts Schedules

Fixed Assets

Balance Sheet

Quality Management Module - some key features

Vendor Approval Raw Material Approval In-Process Approval Finished Product Approval Integration with Nova-LIMS (Optional)

System Architecture
Client Tier Server Tier
Data & Legacy Access Components

Data Tier
Database

Business Logic Components

Legacy Systems

Presentation Layer

Business Layer

Data Access Layer

Data Layer

Deployment architecture
Corp.App Server Corp. users Client Terminals

Corporate Server
SBU Server SBU Server Ethernet or Serial

Client Terminals

Architectural Benefits
Dynamic load balancing - Performance bottlenecks eliminated by distributed processes between multiple servers. Trusted Deployment - Critical business processes are run in the server.

Compliancy upgrades - Managed largely at component level. Hence the impact on other business layers is reduced.
Scalable deployment model - Addition of new SBUs with out affecting existing deployments Easier Change management - Change only server components

Implementation and Deployment Landscape

Our experience with working within the pharmaceutical Industry has lead us to define a 4 system landscape. We believe this gives the best possible solution to implement ERP within this type of industry.

Four System Landscape

Un-Validated Development Server

Validated Development Server

Validated Quality Assurance

Validated Production Server

How the 4 System Landscape works

Un-validated Development system
This is effectively a "sandbox" system / client, a "try it out" system.

Changes would not be recorded on the system, no changes will be

transported out of this system.

By having this "sandbox" system users will be able to better define the Customization requirements that are necessary. By working with both our PharmaERP consultants and yourself together, and this is very important, "together" you will produce more detailed customization requirements.

Our Developers and consultants will configure the system until we have a demo system showing how PharmaERP could run the users processes.

4 system landscape
Validated Development System

(contd.)

This system installation would follow the GAMP model and would be under change control and form the initial installation of the hardware and software. The developer / configurer will apply changes as required but under change control, all supported by documentation. The configuration will be done in a single client called "The Master Client. This "Master Client" is the key to the success of your ERP project. From this client, all changes will be moved through to the other systems and eventually will run your business processes.

Without proper control over this environment, you will have problems, and
problems cost money ! You now have control.

4 system landscape
Validated Quality Assurance System

(contd..)

This system is where all the validated testing (IQ/PQ/OQ)will take place. Data will be loaded in a controlled manner to support testing. The installation would follow the GAMP model and would be controlled under change control from the initial installation,until a change has passed its own test case or been fully approved by the appropriate personnel.

Validated Production System

This is your Production system. From this system you will run your business process to support your company

Validation
Overview
Establish documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes, and operating, maintaining and controlling that system in a manner that complies with current regulatory requirements (source USFDA)

Cost Non-Conformance
Validation is a process that if conducted correctly will assure the regulated bodies that your systems are working correctly as designed if during an USFDA inspection the investigator finds erroneous, incomplete or missing specifications the system may be deemed not to be under a state of control Form 483 =$1000s Warning Letter =$100,000s Product Recall =$Millions Product Approv. =$Millions Imp Detention =$Millions Consent Decree =$150m
(Source USFDA)

Validation Process In PharmaERP etc.. Defined development process e.g V model, Water fall, Spiral,
Validation plan Documented requirements (URS) Documented design specifications (SDD) Design reviews Documented unit specifications Code Reviews Documented testing with evidence Documented evidence of installation

Defined change control process (in development and after go-live)

Documented security arrangements (system access) Complete traceablity Responsibility for sign off

Validation report

Authentication

Authorization

Identification

Data Integrity

21 CFR Part 11
Product Functionality

Audit

Security Administration

Data Disposal

Audit Trail

Complete and independent audit trail based on 21CFRpart11

The audit trail can be viewed by the Sys Admin. Any access, data entry, or modifications are recorded by date, time, user, action, module.

Change Control with reason for change

Compliance - Today and Tomorrow

Compliance expectations change and mature provides upgrades for these changes.

The architecture is scalable enough to accommodate any regulation related changes with minimal impact.
A dedicated team working on Compliance upgrades.

Integration
Seamless Integration with Raw Material Analyzer

Seamless Integration with Finished Product Analyzer

Seamless Integration with Environmental Monitoring Program

Seamless Integration with Stability Program

Seamless Integration with Calibration and Preventive Maintenance Program

Seamless Integration with Document Management System, Audit and Training Program

ERP Implementation cost components

License Cost Implementation & Customization Cost Integration Cost Hardware Cost Maintenance Cost Compliance Cost

Validation Cost

Score on Cost
(ERP Vs PharmaERP)

Adding Pharma industry specific features (GAMP) to a standard ERP is not cost effective is designed as per cGAMP Guidelines and hence covers key pharma processes. Customization for Workflow specific to the organization has a built in Workflow manager that enables customizing the workflow in a simple way.

Score on Cost

(contd..)

Integration effort for consolidating the inputs from various information systems (LIMS, DMS etc) is seamlessly integrated with LIMS and DMS. Cost of compliance and validation is either very high or not viable is fully compliant and offers a standard validation package

ERP implementation Challenges

ERP PharmaERP

Dynamic Business process changes Includes cGAMP processes

Regulatory guidelines

Is fully compliant with 21CFR Part 11

Complex Integration requirements

Seamlessly integrated with LIMS and DMS

Regulatory upgrade Tedious or

not possible

Continuous Regulatory upgrades

fully integrated solution

Material Management

Quality Assurance Nova-LIMS

Manufacturing

Corporate Dash Board

Finance Purchasing

Sales

To summarize

Specially designed and developed for pharmaceutical

manufacturing Compliant to cGAMP and 21CFR Part 11 Fully Validated for IQ, OQ, PQ Reduced implementation cost

Reduced implementation time frame

Integrated with Nova-LIMS and DMS Regular updates to ensure latest Compliance

The road map for tomorrow...

Thank you... How do we begin?