Global Quality Assurance and Regulatory Compliance: The Business Case for an Enterprise-Wide Strategy - A centralized quality control strategy may be the best solution. - BioPharm International


Global Quality Assurance and Regulatory Compliance: The Business Case for an Enterprise-Wide Strategy
A centralized quality control strategy may be the best solution.

BioPharm International
Volume 21, Issue 11

Integrated Systems Management

Enterprise-wide quality and compliance can be streamlined by a single database and management structure, or through a system of integrated tools. Information about training, vendor qualifications, subcontractor competency, and any quality deviations must be monitored from an enterprise perspective, instead of from a plant-specific view. Most importantly, problems identified at one plant can be investigated and resolved proactively at other plants; this can prevent a significant finding that can lead to a citation during a regulatory audit. Interoperability of the quality and compliance functions with other IT-based systems such as purchasing, human resources, document management, and enterprise resource planning, assures consistency of the quality program and promotes cohesive oversight of all functions.

For example, many companies are integrating document management with their training systems, enabling a document update to automatically trigger actions for employees. This solves the compliance challenge of how to efficiently distribute and track new and updated SOPs and other critical documents. Once alerted, typically by email, an employee must not only read the SOP changes, but must demonstrate understanding by passing a quiz; this increases operational efficiency and document-based compliance. Because hundreds of changes a year to SOPs are not uncommon, a manual approach to distribution is unmanageable and is a significant area of risk for the company.

Quality Systems Inspection Approach

The FDA has recently embraced a risk-based approach designed to minimize consumer safety hazards caused by quality problems. The approach prioritizes risks to optimize the FDA's inspection and enforcement resources. This risk-based approach signals a focus on enterprise-wide inspections that span country boundaries based on violations found at a single plant.

A similar strategy can be integrated into a company's compliance programs. Doing so enables the company to take immediate action when problems uncovered in one facility may exist at other plants using similar processes, equipment, or vendors. This method also facilitates compliance with FDA requirements. A commitment to consumer safety is shared by regulators and pharmaceutical companies. By sharing a common approach to quality, both regulators and the companies they regulate enhance consumer safety while minimizing the likelihood of product recalls, plant closings, or suspension of production.


Agility and cohesive thinking are critical for any biopharmaceutical company facing the volatility of the global marketplace, regulatory expectations, and scientific discoveries. What had been a collection of national and regional economies has emerged as a single, interconnected, interdependent global economy. What had been a local workforce, in which longevity and stability were prized, has become a dispersed network of employees with vastly different levels of experience, knowledge, and seniority. And what had been a relatively stable business environment for the industry now reflects an explosion of mergers and acquisitions that necessitates cultural integration, overlapping regulatory requirements, and increased use of outside contractors and subcontractors.

As globalization and a changing workforce become drivers of today's economy, biopharmaceutical companies seek a better way to manage people, plants, and processes while keeping their promise to consumers of quality and safety. That better way is an enterprise-wide quality-based compliance approach that satisfies the needs of consumers, regulators, and the company's stakeholders.

Denise Queffelec is a life sciences practice leader and David Peterson is a director of GMP and quality solutions at Kaplan EduNeering, Princeton, NJ, 609.627.5300,

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