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