Life Sciences Operations
Improving our clients Regulatory, Quality, & Operations functions, addressing business needs with process transformation and technology enablement
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
