life science...life sciences channel management and government pricing gamp®5 compliant s/4...

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

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/

https://www.cognitusconsulting.com/en

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

life science...life sciences channel management and government pricing gamp®5 compliant s/4...

Documents