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Pharma ERP

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Detailed statistics based on locations and periods ... Industry has lead us to define a 4 ... The road map for tomorrow... Thank you... How do we. begin? ... – PowerPoint PPT presentation

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Title: Pharma ERP


1
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2
Introduction
Offered by CCE Software, India and Novatek
International, Canada for Pharmaceutical
Manufacturing Industries
3
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.

4
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.

5
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

6
  • 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
7
- Process Flow
8
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9
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

10
Manufacturing Module- some key features
  • Simulating Production BOMs
  • Recurring Journals
  • Recurring Planing Worksheets
  • Routing definition
  • Capacity Requirement Planning
  • Capacity Journals

11
Manufacturing Module
Manufacturing Module
Reports
BOM Creation
Planned Production Order
Production Forecast
Consumption Journal
12
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

13
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

14
Material Management Module
Material Management Module
Reports
Item maintenance
Item Journals
Transfer Order
Revaluation Journals
15
An example for cGAMP based Process flow
Material Management
16
Purchase Module- some key features
  • Purchase Journals
  • Payment Journals
  • Requisition Worksheets
  • Quotes
  • Blanket Purchase Orders
  • Purchase Orders
  • Invoice handling
  • Return Management

17
Purchase Module
Purchase Module
Reports
Purchase Journal
Purchase Order
Purchase Invoice
Return Order
18
Sales Module- some key features
  • Customer Management
  • Sales Journals
  • Cash Receipt Journals
  • Sales Quotes
  • Blanket Sales Orders
  • Sales Orders
  • Invoice Management
  • Return Order Handling

19
Sales and Distribution
Sales Module
Reports
Sales Journal
Sales Order
Invoice
Order Returns
20
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

21
Finance Module
Finance Module
Bank Accounts
Reports
Balance Sheet
Fixed Assets
Accounts Schedules
22
Quality Management Module- some key features
  • Vendor Approval
  • Raw Material Approval
  • In-Process Approval
  • Finished Product Approval
  • Integration with Nova-LIMS (Optional)

23
System Architecture
Business Layer
Data Access Layer
Data Layer
Presentation Layer
24
Deployment architecture
Client Terminals
25
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

26
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.
27
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.

28
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.

29
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

30
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)

31
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

32
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33
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

34
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.

35
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

36
ERP Implementation cost components
  • License Cost
  • Implementation Customization Cost
  • Integration Cost
  • Hardware Cost
  • Maintenance Cost
  • Compliance Cost
  • Validation Cost

37
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

38
Score on Cost (contd..)
  • Integration effort for consolidating the inputs
    from various information systems (LIMS, DMS etc)

39
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
40
fully integrated solution
Material Management
Corporate Dash Board
41
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

42
The road map for tomorrow...
Thank you... How do we begin?
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