Quality Transformation for Life Sciences

Create an agile Quality function to meet increasing demands

The transformation imperative:

The mission of the Quality function is critical, balancing evolving  regulations, complex products and supply chains, and the need to get products to market quickly. Regulators are pushing companies to leverage technology and data to make real-time decisions related to product efficacy and patient  safety. However, life sciences companies, with complex and matrixed quality organizations, are challenged to strategically meet ever more demanding compliance requirements.

By introducing new quality operations models leveraging innovative, integrated technology, processes can be streamlined, made more robust, and continuously improved; cost can be removed; and the enterprise, and a competitive  advantage, secured.

Benefits of transformation include:

  • Conduct faster regulatory impact assessment and remediation plan
  • Employ a lean, simple, and agile Quality Management System (QMS)
  • Develop a protective and holistic approach to managing quality and compliance risk
  • Harmonize, automate, and integrate to gain efficiencies in end-to-end solutions
  • Drive a quality-centric culture that provides continuous improvement

How we help clients transform Quality:

At KPMG, we help our clients optimize their quality systems, implement new capabilities to meet compliance requirements, and develop strategies to prevent - and remediate - enforcement actions. We design operating models that address not only the needs of today, but anticipate those on the horizon.

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About Healthcare & Life Sciences at KPMG

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QMS Transformation

  • Assess and reengineer existing people, process and technology models to identify inefficiencies
  • Propose and implement robust and sustainable changes to attain desired organizational efficiency and compliance



New Regulations & Standards

  • Ensure organizational readiness for upcoming regulations and standards such as EU MDR, ISO 13485, MDSAP, etc.




Quality & Compliance Digitization

  • Assessment of the current technology infrastructure, implementation of new systems, post-merger integrations, vendor selection and management, application rationalization



Audit Remediation & Preparation

  • Health assessment of Quality Management System to applicable regulations
  • Identification of deficiencies and implementation of quality plan to attain compliance
  • Address audit findings and manage remediation efforts

KPMG Quality Transformation Approach

Health Assessment

A health assessment of a QA  organization, to determine the  maturity level of its Quality  Management Processes:

People – Organization, Talent, Cross  Functional Collaboration

Process – Effectivity, Redundancy,  Regulatory Compliance

Technology – Digitization,  Integration, State of the Art

Implementation Plan

An implementation plan that will help  mitigate regulatory exposure, support  safe and quality products on the  market and drive business objectives.

Future State of Quality Management Processes – Simplified,  effective, agile processes defining  quality systems

Technology Roadmap – Short and  long term strategy defining Quality’s  digital transformation journey

Organization and Talent  Transformation – Resource and  organization model to successfully  sustain the transformation

Steady State Strategy

A strategy to ensure sustained  compliance with continuous  improvement

Metrics – Compliance and  business measurements to  evaluate trends impacting product  and financial decisions

Technology – Ensures cutting  edge technology to ensure data is  reliable and easily available for real  time decisions

Industry Trends – Constant  review of competitors and evolving  standards to remain competitive in  the market


Unique combination of functional and technical expertise – Our teams  are comprised of professionals with deep industry experience and a wide  range of consulting and technical skills.

Leader in operating model transformation – We are recognized by  analysts as a leader in transformation, insights, and change.

We are truly objective – As a recognized trusted third party advisor, KPMG  provides objective and independent assessments.

We have a tried and tested approach – With experience working at  numerous life sciences and pharmaceutical companies, and our services are  customizable for each client’s unique needs.