Gallop life sciences
powered by kymanox

sap s/4hana life sciences solutions
enhanced or automated quality,
validation and compliance

Streamlining FDA compliant SAP S/4HANA solutions for Life Sciences organizations; empowering Pharmaceutical, Medical Devices, Biotechnology and Healthcare companies to automatically stay compliant with FDA, EMA, EUDAMED and PMDA regulations.

Cognitus’ SAP Qualified Partner Packaged Solution Gallop Life sciences powered by Kymanox combines intelligent technologies, industry focused best practices and automatic regulatory compliance, forming a comprehensive solution for Life sciences companies.

When it comes to Life Sciences, compliance is the key. Cognitus has years of experience providing complex and sophisticated solutions to our customers that leverage the SAP S4HANA Life sciences solutions for compliant manufacturing and distribution.

The Cognitus-Kymanox joint package provides a patient-centric approach to the SAP ecosystem by integrating FDA, EMA, EUDAMED, PMDA compliance requirements with business needs, accelerating implementation timelines and mitigating regulatory risk. It offers increased productivity and compliance for Pharma and Medical Device companies supporting Field Service Management, Return Material Authorization and Competent Authority Reporting.

Gallop Life Sciences powered by Kymanox enables a digital supply chain and simplified government pricing that is both adaptable and transparent providing real-time insights; connecting hospitals, patients, distributors and government agencies.

Gallop Life Sciences solution highlights: 21 CFR part 11 compliant Manufacturing, Supply Chain, Quality and Compliance and Order to Cash modules

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 / UDI

compliant supply chain

  • Supplier Qualification and Quality Audits

  • Third party Logistics

  • Stock Transfers

  • DEA/ARCOS Reporting

  • Material Identification and Tracking

QUALITY MANAGEMENT SYSTEM MODULES

  • Clinical Trial Digitalization

  • Non-Repudiation digital signature

  • Quality notifications

  • Corrective and Preventive Action (CAPA)

  • FDA/EMA Submissions

  • Quality Control and Analytics

  • EDMS, LIMS, TrackWise, PTC/Integration

compliant to order cash

  • Product Recall

  • Rebates, Chargeback, Returns, Repairs

  • Purchase orders

  • Service Orders

  • Stock Reorder Suggestions and Forecasts

SAP Implementation and testing based on GAMP V framework that mitigates regulatory risks and ensures a patient-centric approach

With Gallop Life Sciences Powered by Kymanox, we bring you the best of both worlds – SAP Recognized Expertise in Life sciences implementation by Cognitus, and the Life Sciences industry expertise for quality and validation by Kymanox. The partnership makes it possible for Cognitus to provide an outcome-based approach resulting in the following key differentiation.

technology advice without any bias
  • Sustainable Implementation

  • Integrity through process & practice

  • Solution advice for SAP S/4hana

  • Advisory & Special Ops

  • Systems thinking & Best Practice Process

innovation
  • Service, Sell, Build Partner

  • We have IP in Apps

  • SAP S/4HANA Qualified Conversion Factory

  • First Intelligent Enterprise SAP Qualified Package

  • Hackbot/Chatbot Winners with IRPA best practice process

cgxp compliance risk assessment
  • Risk Assessments

  • S/4HANA CGxP Compliance Triage

  • GAMP’5 Compliant S/4HANA

  • Audit Ready

  • Validation Tools/
    Accelerator

s/4 Expertise & b2b expertise
  • 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)

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

WE’RE READY
WHEN YOU ARE.