Insight
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
Our practice
Our capabilities
Meet our team
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
Why KPMG
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.
