Quality Services for Life Sciences

Transform Quality from strategy through implementation, to enable effective Quality Systems using emerging technologies and solutions


How KPMG can help

Our goal is to help our clients improve the effectiveness of their Quality Management Systems (QMS), implement new capabilities to meet compliance requirements, and develop strategies to achieve audit readiness. We design operating models that address not only the needs of today, but anticipate those on the horizon.


Strategy & Governance

Operation Control Confirmation
Engaged quality forming a stabilized compliant business function
  • Facility/Equipment Validation
  • Manufacturing Controls
  • Distribution Management
  • Procurement/Vendor Management
  • Laboratory Controls
  • SOP’s and guidelines
Established quality management system process, procedures and oversight
  • CAPA Management
  • Change Control
  • IT Controls and Validation
  • Complaints Management
  • Vendor/Supplier Quality
  • Document Management
Evaluation of quality management system and operational quality controls
  • Process Audit
  • Product Audit
  • System Audit
  • Audit Framework Design
  • Internal, Supplier, Vendor Audit Execution
  • Inspection Readiness and Remediation

Technology Platform and Digitization

Monitoring, Reporting and Remediation

The Value of Quality

When Quality operations, controls, and audit practices are effectively applied across the framework of the Quality Management System, life science companies experience improved operations excellence, process improvements, regulatory compliance, and product quality.

Our services

We help our clients in their Quality transformation journey from strategy through implementation and execution. Our services not only address the regulatory obligations and compliance requirements but also further enable Quality Management System effectiveness through leveraging emerging technologies and solutions.

Quality Strategy

  • Strategy development
  • Organization alignment
  • QMS Assessment
  • Key Performance Indicators
  • M&A readiness and Transaction support


Quality Operations

  • Process evaluation leveraging industry leading practices
  • Development of robust and sustainable quality controls
  • Data integrity assessment and mitigation
  • Remediation support for regulatory findings

Quality Management System

  • QMS framework, design and remediation
  • CAPA and Deviation management process, evaluation, design and execution support
  • Complaint management evaluation, design and execution support
  • Quality Manual, Policy and SOP development

Computer Systems Validation

  • Validation Strategy Assessment, design and remediation
  • Validation execution support: Protocol Development, Testing, technical writing
  • Validation strategies for new technologies and standards


Quality Audit

  • Assessment/Audit of Quality Management System across process, product and systems
  • Mitigation development, prioritization and roadmap to support continuous process improvement and Risk Reduction



Quality Technology and Digitization

  • Business process and requirements definition
  • Technology vendor selection
  • Solution architecture and design
  • Solution implementation and deployment support
  • Application rationalization and upgrade support

Contact us

Rajesh Misra

Rajesh Misra

Principal, Life Sciences Advisory, KPMG US

Timothy Johnson

Timothy Johnson

Managing Director, Life Sciences Advisory, KPMG US

+1 609-917-8801