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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

Engaged quality forming a stabilized compliant business function

  • Facility/Equipment Validation
  • Manufacturing Controls
  • Distribution Management
  • Procurement/Vendor Management
  • Laboratory Controls
  • SOP’s and guidelines

Control

Established quality management system process, procedures and oversight

  • CAPA Management
  • Change Control
  • IT Controls and Validation
  • Complaints Management
  • Vendor/Supplier Quality
  • Document Management

Confirmation

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.

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Quality Strategy

Quality Strategy

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

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
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Quality Management System

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
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Computer Systems Validation

Computer Systems Validation

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

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
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Quality Technology and Digitization

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
Quality Strategy Quality Operations Quality Management System Computer Systems Validation Quality Audit Quality Technology and Digitization

Dive into our thinking:

Risk mitigation, value maximization in M&A - KPMG Quality Services

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Meet Our Team

Image of Rajesh Misra
Rajesh Misra
Principal, Life Sciences Advisory, KPMG US
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Image of Timothy Johnson
Timothy Johnson
Advisory Managing Director, C&O Commercial, KPMG US
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Image of Rajesh Misra
Rajesh Misra
Principal, Life Sciences Advisory, KPMG US
Read bio
Image of Timothy Johnson
Timothy Johnson
Advisory Managing Director, C&O Commercial, KPMG US
Read bio

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Some or all of the services described herein may not be permissible for KPMG audit clients and their affiliates or related entities.

The information contained herein is of a general nature and is not intended to address the circumstances of any particular individual or entity. Although we endeavor to provide accurate and timely information, there can be no guarantee that such information is accurate as of the date it is received or that it will continue to be accurate in the future. No one should act upon such information without appropriate professional advice after a thorough examination of the particular situation. KPMG LLP does not provide legal services.

The information contained herein is not intended to be “written advice concerning one or more Federal tax matters” subject to the requirements of section 10.37(a)(2) of Treasury Department Circular 230.

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