Quality Services for Life Sciences

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.

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

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.