Pharma SIG

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(No Transcript)
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Pharma SIG

• Presented by Adam Prince

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Agenda

• Update on iScala 2.3
• New features with Pharma impact
• 21 CFR Part 11
• Audit DB
• iScala Field Level Security
• Developing Greater Global Reach
• Latin America including Brazil Argentina
• Drug Authentication RFID

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iScala 2.3 Features (1/2)

• Improved Security
• Field level security (see later)
• Many new permissions
• Re-authentication with audit trail of
  success/failure
• SRP/MRP create PO type 0 or requisition
• Additional approval stage
• Retains full support for supplier restrictions
• Sub-contracted Manufacturing
• For any industry
• Issue batch controlled raw materials
• Product Planning (planned for FHF)
• Make/sub-contract/buy in planning (MPS)
• Forecast consumption
• Planning Time Fence

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iScala 2.3 Features (2/2)

• Sales Contracts
• Stock reservations
• Legal contracts with price framework and call-off
• ATP and LTM
• Purchase and sales with more predictability
• iScala Collect
• Bar-code solution for the warehouse
• Manufacturing and WMS planned for 2007

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21 CFR Part 11

• Authentication and no-repudiation
• iScala 2.3 Re-authentication for back-office
• At any menu point or iScala field
• Log of success and failure
• iScala password, can also link to biometric
• Digital Signatures for integration
• Prove authenticity of all imports if XML/web
  services
• Sign all outputs if XML/web services
• Non-repudiation
• Many ERP vendors rely on manual processes
• Epicor offers Audit DB via marketing partnership
• What does user group need?

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Greater Global Reach

• One version globally
• Simplified FDA and other Market Authority
  validation
• Lower cost if centralize installations
• Standard solution to deploy wherever it is needed
• iScala 2.3
• Adds support for Argentina and Brazil
• iScala 2.3 SR1
• Plan to merge in final partner versions

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Drug Authentication RFID

• iScala Collect is released with iScala 2.3
• Standard and Advanced warehouse solutions
• Manufacturing planned for H1 2007
• WMS including RFID planned for H2 2007
• Increasing trend to provide validation on the
  bottle
• RFID based solutions with programmable (active)
  tags
• What does iScala need to add to support pharma
  needs?

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Discussion Points

• Any industry groups that Epicor should be part of
• Any partnerships we should work towards
• Any features that we should be development
• What else can we do to help you?