Pharma ERP

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

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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.

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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

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• Salient Features
• Designed and Developed to follow cGAMP
  guidelines
• 21 CFR Part11 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

21 CFR Part 11 compliant
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- Process Flow
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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

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Manufacturing Module- some key features

• Simulating Production BOMs
• Recurring Journals
• Recurring Planing Worksheets
• Routing definition
• Capacity Requirement Planning
• Capacity Journals

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Manufacturing Module
Manufacturing Module
Reports
BOM Creation
Planned Production Order
Production Forecast
Consumption Journal
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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

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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

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Material Management Module
Material Management Module
Reports
Item maintenance
Item Journals
Transfer Order
Revaluation Journals
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An example for cGAMP based Process flow
Material Management
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Purchase Module- some key features

• Purchase Journals
• Payment Journals
• Requisition Worksheets
• Quotes
• Blanket Purchase Orders
• Purchase Orders
• Invoice handling
• Return Management

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Purchase Module
Purchase Module
Reports
Purchase Journal
Purchase Order
Purchase Invoice
Return Order
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Sales Module- some key features

• Customer Management
• Sales Journals
• Cash Receipt Journals
• Sales Quotes
• Blanket Sales Orders
• Sales Orders
• Invoice Management
• Return Order Handling

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Sales and Distribution
Sales Module
Reports
Sales Journal
Sales Order
Invoice
Order Returns
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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

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Finance Module
Finance Module
Bank Accounts
Reports
Balance Sheet
Fixed Assets
Accounts Schedules
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Quality Management Module- some key features

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

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System Architecture
Business Layer
Data Access Layer
Data Layer
Presentation Layer
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Deployment architecture
Client Terminals
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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

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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.
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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.

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4 system landscape (contd.)

• Validated Development System
• 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.

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4 system landscape (contd..)

• Validated Quality Assurance System
• 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

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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)

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Validation Process In PharmaERP

• Defined development process e.g V model, Water
  fall, Spiral, etc..
• 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

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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

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Compliance - Today and Tomorrow

• Compliance expectations change and mature

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

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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

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ERP Implementation cost components

• License Cost
• Implementation Customization Cost
• Integration Cost
• Hardware Cost
• Maintenance Cost
• Compliance Cost
• Validation Cost

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Score on Cost (ERP Vs PharmaERP)

• Adding Pharma industry specific features (GAMP)
  to a standard ERP is not cost effective

• Customization for Workflow specific to the
  organization

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Score on Cost (contd..)

• Integration effort for consolidating the inputs
  from various information systems (LIMS, DMS etc)

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ERP implementation Challenges
PharmaERP
ERP
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
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fully integrated solution
Material Management
Corporate Dash Board
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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

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The road map for tomorrow...
Thank you... How do we begin?