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.
MEETING THE CHALLENGE
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
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
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,