it.lifescience

SAP S/4HANA Powered Intelligent Business Suite For Life Science Industry

Business Challenges

Compliance, Quality & Operations

  • Local and Global regulatory requirements
  • 21 CFR Part 11, cGMP and FDA guidelines
  • Streamline and shorten manufacturing life cycles
  • Higher costs of bringing drugs to market

Batch Traceability

  • Eliminate Manual intervention
  • Effective traceability and tracking of the products during the entire product chain
  • Increasing alliances, partnerships and outsourcing

Integrated Quality & Risk Management

  • Co-ordinate Product Development, Production and Formula Management
  • Ensure patient safety, prevent counterfeit products and minimize compliance cost

Corrective & Preventive Action

  • Short-term actions to address the immediate problem
  • Long-term actions to prevent the recurrence of a problem

Contract Manufacturing

  • Simplifying collaboration
  • Single collaboration platform – Internal and Third Parties

Supply Chain Optimization

  • Integrate, Automate Sourcing and Procurement
  • Full visibility into spend and supplier performance

Finance

  • Inventory Costing and Tracking
  • Financial Planning and Analysis
  • Accounting and Finance close

Scope and Deliverables

Standard S/4HANA

  • SAP Fiori
  • S/4HANA Analytics

Manufacturing

  • Regulated process Manufacturing
  • Active Ingredient Management
  • Campaign Production
  • Batch Management – Cockpit and traceability
  • Capacity overview and Scheduling

Quality Management

  • Sample Management
  • Quarantine System
  • Test Specification Management
  • Shelf Life Management
  • Certificate of Analysis

Quality Control

  • Incident Management
  • Statistical Quality Control
  • Digital Signature
  • Stability Study
  • Change Management
  • Document Standard Process

Maintenance

  • Operational and Preventive maintenance
  • Equipment Calibration

Logistics

  • Demand and Supply Planning
  • Inventory Management
  • Material Requirement Planning
  • Dispensing details
  • Sales Order Management
  • Contract Manufacturing
  • Product Returns and Product Recall

Finance

  • Accounts Payable, Accounts receivables
  • Product Cost accounting
  • Accounting and Financial close
  • Asset Accounting

Business Value

  • A fully integrated system with increased efficiency and Compliance.
  • SAP Qualified Solutions – Pre-packaged Proven Pharma solutions with successful Go-Lives
  • Proven Industry best Practices for API, Bulk and Formulations for small, medium and large scale Pharma Industries
  • Regulated Process Manufacturing
  • Solutions comply with 21 CFR Part 11 and cGMP
  • Increased operational effectiveness and productivity
  • Global adaptation of best practices
  • Improved Batch tracking Management
  • Balanced inventories and minimized stock outs

Why itelligence India

  • 15 Years of Pharma Industry Experience
  • 60 Consultants with Pharma Industry Knowledge
  • 70 Preset Process covering Regulated Manufacturing, 21 CFRPart 11 and cGMP
  • Pharma Industry Specific Dashboards & Regulatory Compliant system that withstand audits

Package Information

Total Implementation Time:
16 weeks Implementation + 4 Weeks Go Live Remote Support


Number of Users:
50


Service / Modules Included:
(* One Time Implementation Charges* Includes Implementation +SW License based on licensed 50 users)

Package Information

Total Implementation Time:
20 weeks Implementation + 4 Weeks Go Live Remote Support


Number of Users:
100


Service / Modules Included:
(* One Time Implementation Charges* Includes Implementation +SW License based on licensed 100 users)


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