Supply Chain Security for Life Sciences

Leading global organizations to meet their Serialization, Traceability, and Device Tracking compliance requirements and optimize their business operations.

Serialization & Traceability

We help Rx Manufacturers, Re-packagers, and Distributors meet their compliance requirements and also to implement processes and controls that achieve improvements in quality and reduction in operational and administrative expenses through pharmaceutical serialization and traceability.

Legislation and regulations such as the U.S. DSCSA and the EU FMD required rapid deployment of technologies and integrations. If not carefully planned, designed, qualified, and implemented, the organization’s solution landscape can become a disparate collection of software versions, configurations, functionalities, and integrations, contributing to a company’s overall operating costs and compliance risks.

KPMG is equipped to review your entire Serialization, Traceability, and Reporting solution landscape, or to focus on a specific operational / functional area based on your operating environment, risks, and opportunities. 

Stage 1: Drive Serialization and Product Tracking compliance


New / revised manufacturing sites, lines and equipment


New / revised products, legislation, and business development / markets


New / revised suppliers
(3PL, 3PPs, CMOs)


New / revised customers


New / revised systems and data

 

 

 

 

 

 

Stage 2: Build Serialization and Product Tracking sustainability

 

Change Control System

 

Labeling & Artwork System


 

Quick Hit Sustainability Mechanisms

 

Regulatory Intelligence


 


Trade Agreements


QA Agreements
 

Device Tracking

We help global device Manufacturers modernize their complaints handling and device tracking processes with enabling technologies scaled to their specific needs, in order to modernize their device tracking platform and improve their overall quality management system. 

Device Tracking regulations such as US FDA 21 CFR Part 821 and Canada Medical Devices Regulations Part 1 Section 66-68 require tracking of certain implanted devices these requirements are intended to facilitate notification and recall in the event a device presents a serious risk to health that requires prompt attention.

Our flexible device tracking solution addresses the end-to-end device tracking process by integrating the device tracking, complaints, warranty claims and regulatory reporting processes, within a scalable, low-code, cloud platform.

Customer portal
(for device registration, data verification, Service requests)



 

Other intake
(email, fax)

Document processing
(doc capture, OCR, batching)

Integration
(Internal & External systems)

Device tracking system

(workflow-based application to maintain data on device location and status)

Master data

Transaction data

  
Collect 
data
Maintain
data
Provide
service
 
  • Data migration
  • Data privacy
  • Localization

Field Actions Management
(workflow-based application to manage field actions and feedback)

Mailing & letter generation
(templates, mailing groups, tracking mail, responses)

Quality process audit
(audit data & process, quality coaching)

Reporting
(std./ad-hoc reports, dashboards, alerts)

Contact us

Dave Colombo

Dave Colombo

Director, Life Sciences Advisory, KPMG US

+1 317-616-2505
Sarath Ramakrishnan

Sarath Ramakrishnan

Director, Life Sciences Advisory, KPMG US

+1 312-665-1174
Rajesh Misra

Rajesh Misra

Principal, Life Sciences Advisory, KPMG US

+1-617-988-1184