Nearly every aspect of business
operations has an effect on quality. Despite this fact,
many organizations aren’t leveraging today’s
technology to address this fundamental quality mandate.
Corrective and preventive action management is a daunting
process that most organizations struggle to handle manually;
economies of scale in many organizations highlight the limitations
of this approach. In contrast, effective management of the
CAPA process not only ensures product quality but also makes
good business sense for organizations that choose to adopt
an automated approach.
As more organizations embrace CAPA management as an essential
quality process, it’s important for them to carefully
evaluate the requirements of an effective CAPA system and
determine the most effective and practical approaches to
addressing those requirements. To achieve the greatest return
on technology investment, companies need to adopt a top-down
enterprise approach to CAPA management.
The heart of an effective CAPA program is consistency.
Consistency ensures quality. Developing an effective CAPA
management program requires a shift in thinking, from a
bottom-up to a top-down approach to system implementation.
Many organizations today implement CAPA management solutions
as bottom-up “point” solutions that are implemented
departmentally to serve the needs of specific user groups.
Bottom-up point solution implementations have limited
effectiveness in achieving operational efficiency and addressing
systemic quality problems because they lack broad enterprise
reach. These compartmentalized solutions can actually contribute
to a decrease in operational efficiency--and even threaten
quality goals--if systems lack compatibility or require
customization to achieve compatibility with the enterprise.
The nature of effective quality management involves identifying
root causes of problems or taking proactive steps to prevent
quality problems before they occur. This requires integration
of front-end and back-end systems such as enterprise resource
planning, document management and CAPA applications across
departmental business processes. These systems extend across
the enterprise to identify, detect and correct quality problems
within the organization in a closed-loop fashion. This approach
avoids disconnects that lead to inherent quality problems
that go largely undetected in most organizations. Establishing
an effective, fully integrated quality management system
can be somewhat complex, depending on the organization,
but the advanced CAPA systems available today make this
Many CAPA packages are database-oriented in their design
and architecture, enabling organizations to enter and manage
an event through a workflow process. These packages also
include support for the latest regulatory guidelines, such
as ISO standards or the Food and Drug Administration’s
21 CFR Part 11 guideline on electronic signatures. Unfortunately,
these systems lack integration with other key business processes,
which limits their overall effectiveness in addressing real
Utilizing a CAPA package has some merit in small organizations
with perhaps a single geographic location and centralized
operations. However, in most midsized and larger organizations,
CAPA events cover a broad spectrum of issues and can affect
many departments and divisions. Almost anyone in an organization
can either raise a corrective action event or be a participant
in a corrective action process at any time. This alone requires
rethinking the “point solutions” approach to
automating the corrective actions process.
CAPA management is a collaborative process requiring interaction
and input across various parts of the organization. Enterprise
access is key to ensuring successful deployment of a CAPA
Enterprise compliance management represents a holistic
approach to regulatory compliance. Collaboration and consistency
are the keys to achieving compliance and reducing associated
risks. When applied across multiple lines of business, enterprise
compliance management systems, such as CAPA, ensure that
regulatory applications are deployed in a cohesive and integrated
manner. Effective management of CAPA requires this kind
of comprehensive strategy.
Most organizations already employ a document management
system for their quality documentation. Throughout a typical
CAPA investigation, these documents are often accessed for
reference. However, because CAPA and document management
systems are often disparate and nonintegrated, error-prone
hybrid (e.g. manual/electronic) processes are developed
that can lead to additional problems.
A good CAPA program should integrate traditional document
management, ERP and other process technologies seamlessly,
enabling ready access to quality documentation throughout
the corrective action process. This approach assumes a fully
electronic workflow across the organization, utilizing 21
CFR Part 11-compliant electronic signatures, when appropriate.
In the past, the vision of enterprise compliance management
escaped many organizations. Customization was considered
the most effective way to address requirements over the
long term. In hindsight, however, the drive for customization
led to extensive system implementations that largely failed,
costing organizations millions of dollars in development,
validation and implementation. Organizations are now looking
to the vendor community for off-the-shelf applications that
can be readily deployed across the enterprise and are easy
to integrate without expensive customization. This is the
essence of enterprise compliance management systems today.
The primary issue with CAPA management is that corrective
actions often aren’t properly followed through, documented
and closed in a timely manner. This can lead to further
product quality problems and regulatory fines.
A CAPA management system must include the following key
Enterprise access and collaboration
Closed-loop corrective action plan process (providing perpetual
“triggers” and reminders to close the loop)
Compliance with current regulations
Integrated solution (vs. “point”solution) should
seamlessly integrate document management, ERP, records management,
event management, workflow, task management, records management
and project management.
Comprehensive statistical analysis
Flexible, task-oriented workflows
Enterprise collaboration is an essential requirement for
a good CAPA program. As employees execute tasks in a corrective
action plan, they exchange information, ideas and data in
a collaborative manner. This collaboration should be seamlessly
integrated into the way they do business. Many people use
e-mail for ad hoc collaboration and correspondence on quality
issues. E-mail is easy to use and readily accessible across
the enterprise, which is why it’s the communication
medium of choice in so many organizations. Most employees
have e-mail, yet e-mail isn’t always a secure, validate-able
medium. A CAPA system must be as easy to use as e-mail and
provide a higher level of security and auditing, in compliance
with regulatory requirements. To ensure successful user
adoption of a CAPA system, it must be easy to use, deployed
enterprisewide and integrated into normal business processes.
Effective records management is essential to any enterprise
compliance management system, including CAPA. CAPA systems
are inherently data-oriented, as opposed to document-oriented.
Therefore, as CAPA events are documented and closed within
the system, they become official records and require the
same level of regulatory control as all cGxP records governed
by 21 CFR Part 210 and 211. Thus, effective management of
electronic records requires a comprehensive records management
Many CAPA management system developers don’t realize
the legal consequences faced by their customers for ineffective
management of electronic records. Their CAPA system offerings
ignore the critical records-management component altogether.
For example, in the heavily regulated life sciences industry,
organizations can generate terabytes of electronic records,
but lack the ability to ensure their integrity and authenticity
as records migrate over time. An effective CAPA system should
include a foundation of a good records management strategy.
An efficient CAPA system should help organizations avoid
manual processes and unnecessary data entry. This facilitates
the successful execution, documentation and closure of corrective
Regulatory compliance is no longer considered a “necessary
evil.” Many companies are finding that, if implemented
properly, a successful CAPA management system makes good
business sense and can yield bottom-line results. As stressed
throughout this article, a good CAPA system requires an
A well-chosen CAPA management system can deliver a significant
return on an organization’s technology investment,
realized by leveraging existing technology that extend CAPA
management capabilities across the enterprise. Recent case
studies suggest that the return on investment can be as
high as 300 percent over a two-year implementation period.
In many cases, well-chosen CAPA management systems are paying
for themselves in fewer than six months.
Integrating processes and procedures across the organization
yields benefits far beyond the CAPA process. World-class
organizations are beginning to understand the long-term
value of enterprise compliance management and are adopting
CAPA systems that extend across their enterprises. These
changes will ultimately improve overall product quality
and safety, and affect our lives for years to come.
Valarie King-Bailey is chief marketing officer for
QUMAS, an Enterprise Compliance Management Systems vendor.
She is a frequent speaker on compliance issues. Letters
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