6 Dimensions of Maturity for Quality and Compliance Success in Life SciencesMatthew LittlefieldPresident and Principal Analyst

EQMS Life Sciences Maturity Roadmap

Ad-hoc Controlled Proactive Agile Market Leader

Strategyand Execution

Quality disconnected from corporate objectives

Quality fully integrated with corporate objectives

Leadership and Culture

Quality is a department rather than shared responsibility

Quality integral part of overall Operational Excellence

Organizational Capabilities

Quality distinct from corporate structure. Not in goals or incentives.

Quality fully integrated into corporate structure

Business Process Excellence

Disconnected and disparate

Global integrated and harmonized

Technology Capabilities

Disconnected and disparate

Global integrated and harmonized. Fully embracing emerging capabilities.

Performance Management and KPIs

Non-role based, manual KPIs, disconnected from corporate goals

Predictive, role-based, real-time metrics connected to corporate goals

Technology Capabilities

Current System Landscape

• Enterprise Resource Planning (ERP)

• Financial data, inventory data, production routings, recipe management

• Business Intelligence (BI)

• Reporting, Analytics, Visibility

• Customer Relationship Management (CRM)

• Customer complaints, trade promotions

• Product Lifecycle Management (PLM)

• Product data, manufacturing process, quality inspection, quality by design

• Manufacturing Operations Management (MOM)

• In-line and at-line testing, statistical process control (SPC), manufacturing non-conformances

• Supply Chain Management (SCM)

• Supplier risk, scorecards, delivery scheduling, inspection

• Environment, Health, and Safety (EH&S)

• Carbon management, energy management, reporting

EQMS Architecture

EQMS Adoption

• EQMS has higher adoption rates in Life Sciences as well as more in the planning stages

Adoption of EQMS of Functionality

• Supplier Quality Management is lagging for Life Sciences

• NC/CAPA, Doc Control, and Training are leading for Life Sciences

Improving OEE

• Implementing EQMS improves median OEE by >7%

Maturity Roadmap – Technology Capabilities

Ad-hoc Controlled Proactive Agile Market Leader

Technology Capabilities

Disparate and unstandardized instances of quality processes and functionalities

Broad set of integrated and extended EQMS functionality adopted: GxP, Audit, Compliant, Risk, etc.

Standalone quality processes not connected to broader enterprise

Closed-Loop Quality through interoperability with enterprise applications

High-level quality metrics and KPIs manually collected and calculated

Deep quality and business management analytics: real-time and role-based

Information stuck in silos with resource-intensive collaboration

Cloud and Mobile enabled to extend the quality enterprise and foster collaboration

Disconnected and disparate

Social Media and IoT enabled to change the patient/customer interaction

Investments justified with soft financial savings

Investments justified with Cost of Quality model

Thank You!!Matthew LittlefieldPresident and Principal Analystmatthew.littlefield@LNSResearch.com