Post on 24-Aug-2020
transcript
powered by
Life Science
© 2019 Cognitus Consulting LLC. All rights reserved.Copyright © Kymanox. All Rights Reserved.
KYMANOX - COGNITUS STRATEGIC PARTNERSHIP• Contractual strategic alliance between Life
Science expert, Kymanox, and SAP Gold Partner, Cognitus
• Streamline FDA compliant SAP S/4 HANA solutions for Life Sciences organizations.
• Joint offering is being branded as “Gallop for Life Sciences – Powered by Kymanox” and is visible in the SAP ecosystem.
• Cognitus is primarily responsible for SAP S/4HANA expertise, Integration, and Analytics
• Kymanox is primarily responsible for Quality, Validation, and Compliance
COGNITUS PORTFOLIO• SAP S/4 HANA on-premise, STE and MTE Full Lifecycle
implementations• ECC to S/4HANA Factory Conversion Approach – Gallop• PriceFx and Vistex Implementations and Support• Digital Customer Engagements – SFDC, Microsoft Dynamics &
C/4HANA• Gallop I.E Qualified Partner Package – Project Life Cycle
Management• Revenue Compliance – IFRS15 & Lease Management
Compliance – IFRS16• Analytics – B/4HANA, Azure, Power BI• SAP Advisory Services• Mergers and Acquisitions• Success Factors and HR integration• Ariba• SAP Analytics Cloud• Concur and Fieldglass • Fiori and Technical Integration Services
KYMANOX PORTFOLIO• Professional services to pharma, biotech, and device organizations across a
full-range of CMC and clinical specialties
• Broad and deep expertise across all development, manufacturing, analytical, distribution, and clinical activities
• Focus on late-stage commercialization of FDA and EMA regulated products
• Recognized expert on FDA 483, Warning Letter, and Consent Decree Remediation
• Strong in every FDA and ISO Quality Management System
• Patient-centric approach to the SAP ecosystem that integrates regulatory requirements with business needs, accelerates implementation timelines, and mitigates regulatory risk
• In-house blend of professionals with combined domain expertise across all critical disciplines necessary for implementing compliant solutions
• Team includes business process, medical, scientific, regulatory and software experts, with practical experience in Biotechnology, Pharmaceutical, and Medical Device development and manufacturing
• SAP Multilingual training
The Kymanox Intelligent Enterprise Team is an international provider of ERP
compliance (e.g., FDA, EMA) solutions for life sciences. As pragmatic client
advocates, we offer a patient-centric, risk-based approach balanced with both
regulatory requirements and business needs.
Be More Productive.Get More Done.
KYMANOX CSV PORTFOLIO
Be More Comprehensive.Get More Done.
Suite of procedures and templates that provide a foundation for implementing a comprehensive Computer System Validation (CSV) including:• Validation Project Plans (VPPs) • Part 11, Gap, and Risk Assessments• User Requirements (URS), Software
Requirements Specifications, Software Design Specifications, Traceability Analysis, and Design Review
• Commissioning Protocols, Validation Protocols (IQ/OQ/PQ), and Final Reports
• Entire site and corporate gap assessments and subsequent remediation addressing all software and computer systems and potential CGxP impact.
• SAP and other Enterprise Resource Planning (ERP) software including all modules impacting CGMP operations.
• Commercial Off-the-Shelf (COTS) and custom software including Laboratory Information Management Systems (LIMS), Electronic Document Management Systems (EDMS), Electronic Quality Management Systems (QMS), Building Management Systems (BMS), Environmental Monitoring Systems (EMS), and complaint handling and related pharmacovigilance reporting systems.
• Graphics software used in medical devices and CGMP manufacturing.
• Laboratory instruments and automated manufacturing and utility equipment using DCS, SCADA, PLC, and HMI.
• Serialization systems per FDA Drug Supply Chain Security Act (DSCSA).
Proven Past Performance
SAP ENHANCED CUSTOMER EXPERIENCE (CX) Cognitus is a recognized SAP expert, Gold Partner, and
certified S4/Hana conversion factory across many industries and offers US-managed / off-shore talent for large-scale projects.
Kymanox provides premier professional services to pharma, biotech, and device organizations across the globe for Right-First-Time commercialization efforts across a full-range of CMC and clinical specialties.
To better serve SAP clients in Life Sciences, Cognitusand Kymanox have formed a one-team partnership to offer pre-configured SAP solutions compliant with FDA, EMA, and global regulatory bodies.
• SAP CGxP Compliance Risk – Implementation Readiness and Gap / Risk Assessments
• Pre-implementation SAP CGxP Compliance Triage
• CGxP Process Optimization for SAP .
• GAMP®5 Compliant S/4 Implementation, Testing, and Training
• Supply Chain Risk Reviews and Management
• Best-in-Class, Audit-ready Documentation
• KymanoxWORKS – SAP Validation Tools and Project Accelerators
SAP Solution Highlights
Powered by
GALLOP FOR LIFE SCIENCES
Compliant Supply Chain• Supplier Qualification and Quality Audits• Third Party Logistics• Stock Transfers• DEA/ARCOS Reporting• Material Identification and Tracking
Compliant Order to Cash• Product Recall• Returns• Purchase Orders• Stock Reorder Suggestions and
Forecasts
All Quality Management System Modules• Clinical Trial Digitization• FDA/EMA Submissions• Quality Control and Analytical• EDMS, LIMS, and TrackWise• 21 CFR Part 11 & Annex 11
Compliant Manufacturing• SOPs, Batch and Device History Records• Lot Release (Raw Materials, Intermediates
and Final Product) • QC Sampling, Testing, and Reporting• Product Expiration Management• Serialization Manufacturing Quality and
Compliance
Supply Chain Order to Cash
21 CFR Part 11 Compliance
Powered by
LIFE SCIENCES CHANNEL MANAGEMENT AND GOVERNMENT PRICING
GAMP®5 COMPLIANT S/4 IMPLEMENTATION, TESTING, AND TRAINING
Gap Assessment + Requirements
Data Integrity + Compliance + Validation + Training Plans
Leveraged Protocols
Final Reports
Project Preparation
Business Blueprint Realization Finalize
PreparationGo Live and
Support
UserRequirements
Functional Specification
Design Specification
Module (Unit) Specification
System Build / Configuration + Commissioning (DQ)
RequirementsTesting (PQ)
Functional Testing (OQ)
Integration Testing (IQ)
Module (Unit) Testing (IQ)
CLIENT
COGNITUS + KYMANOX
Legend
CGxP Quality and Compliance Phases
SAP Implementation
Phases
Training LCM + Change Management
Testing + Trace Matrix
Risk-Based Approach and Subject Matter Expertise
KEY DIFFERENTIATORS
◆ Sustainable Implementation
◆ Integrity through process & practice
◆ Solution advice for SAP S/4Hana
◆ Advisory & Special Ops
◆ Systems thinking & Best Practice Process
◆ Risk Assessments
◆ S/4HANA CGxPCompliance Triage
◆ CGxP Process Optimization
◆ GAMP®5 Compliant S/4HANA
◆ Audit Ready
◆ Validation Tools/Accelerator
◆ Solution Architects with 15+ years SAP/ Pricefx / Vistex® -B2B Experience
◆ Functional / Technical Consultants with Average 15 Years SAP Experience
◆ Integration Expertise (Cloud Platform, API, 3rd party)
Technology advice without
any bias
CGxP Compliance Risk Assessment
S/4 Expertise & B2B expertise
Global Force
◆ Only Strategic deliverables executed On-shore
◆ Cost reduction of 30%+ compared to other Integrators
◆ Global Delivery & Support tailored to specific needs
◆ Support for Localization
◆ Service, Sell, Build Partner
◆ We have IP in Apps
◆ SAP S/4HANA Qualified Conversion Factory Gallop
◆ Frist Intelligent Enterprise SAP Qualified Package
◆ Hackbot/Chatbot Winners with IRPA
Innovation
THE INTELLIGENT ENTERPRISE GUIDED OUTCOMES
NEXT GENERATION OF COMPLIANT BUSINESS PROCESSES
Embedded Intelligence | Harmonized Experience | Unified Integration | Flexible Extension
DATA
SPEED OF INNOVATIONEFFICIENCY AGILITY
Extend | Integrate | Build | ExperienceDigital Core
LIFE SCIENCE CLIENTS
LINKS• https://www.cognitusconsulting.com/en
• https://www.kymanox.com
• https://www.kymanox.com/info-sheets
• https://www.kymanoxworks.com
• https://www.galloptos4hana.com/gallop-pilot
• https://www.galloptos4hana.com/gallop-deployment
• https://www.galloptos4hana.com/resources
• https://www.hamilton.one/
• https://www.sap.com/documents/2019/10/c4353f26-6e7d-0010-87a3-c30de2ffd8ff.html
• https://www.sap.com/assetdetail/2019/10/f2ab2726-6e7d-0010-87a3-c30de2ffd8ff.html
• https://kymanox.com/2017/05/25/sap-erp-fda-compliance/
• https://www.kymanoxworks.com/product/erp-gap-assessment/
• https://kymanox.com/wp-content/uploads/2019/07/KYM_SAP-Compliance_v1.pdf
• https://www.kymanoxworks.com/kymanox-knowledge-bar-training/
+1 919.246.4896
info@kymanox.com
www.kymanox.com
KYMANOX
Brian Freymann | Director, Enterprise Solutions | brian.freymann@kymanox.com
Rolando Vega | Principal Advisor | rolando.vega@kymanox.com
Michelle Wall, PhD | Manager, Engineering Solutions | michelle.wall@kymanox.com
COGNITUS
Nitin Khanna | S/4HANA Solution Delivery Lead | nkhanna@cognitusconsulting.com
Raminder Ahlawat | Practice Lead – Life Sciences | rahlwat@cognitusconsulting.com