Automating CAPA Processes
in FDA and ISO compliance environments
Corrective and Preventive Action (CAPA) — the
overall effort to investigate and correct quality
issues to prevent recurrence — is the crux of any
quality system. It is a regulatory requirement that
both FDA inspectors and ISO auditors consider
singularly critical. When implemented properly, a
CAPA software system improves product quality and safety,
increases customer satisfaction, and more
importantly, ensures FDA and ISO compliance.
MasterControl CAPA™ is a robust, easy-to-use
software application designed to effectively manage the corrective
action / preventive action process and integrate it
with other processes critical to regulatory
compliance, such as change control, audit, and
customer complaints.
Here's how MasterControl CAPA
software addresses some of the major challenges that
companies face in establishing and maintaining
effective corrective and preventive action
processes:
CAPA
Management Challenges
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MasterControl CAPA™ Software System
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Inefficient CAPA System
Paper-based and hybrid CAPA systems are
inexpensive initially. In the long term,
however, these systems are inefficient,
requiring tremendous man-hours in terms of
routing CAPA tasks and other documentation,
obtaining approval and signatures, and
manual search and retrieval of documents
during inspections and audits. |
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Efficient
CAPA Process Management Software
MasterControl CAPA automates routing,
notification, delivery, escalation and
approval of CAPAs and all related
documentation. It automates management of
the entire CAPA process, from initiation to
investigation and all the way through to
closure. Provides a secure, centralized, and
Web-based repository for all CAPA documents.
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Disconnected CAPA Processes
A CAPA may be triggered by Form 483
findings, ISO quality audits, customer
complaints, or some other source. With
manual and hybrid systems, these sources are
not connected, making data collection slow
and incomplete. Without connectivity,
critical information may fall through the
cracks, and the root cause investigation is
likely to be unreliable.
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Connected
CAPA Management Software System
MasterControl integrates the CAPA process
with the rest of the quality system for a
holistic approach. For example, the
resolution of a corrective action will
trigger an engineering change, an SOP
change, and retraining of employees on the
new SOP. |
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Poor CAPA
Reporting System
When customer complaints, deviations,
adverse events, and other incidents that can
trigger CAPA are collected manually, there's
no guarantee that all critical information
will be captured because it is easy to
misplace (and time-consuming to update)
paper reports. A hybrid system requires
re-entering data from hard copy into an
electronic system, a process prone to delay
and mistakes.
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Efficient CAPA
Reporting System
A CAPA form can be launched
directly from another form (i.e., customer
complaint, etc.) to streamline the CAPA
process and avoid mistakes during re-entry
of data. Links are maintained so users can
review a completed process and easily see
what triggered the CAPA.
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CAPA System:
Lack of Oversight
Poor implementation of CAPA (a top reason
for issuance of a Form 483) may stem from
the lack of ability to track and monitor
open CAPAs and proactively improve the CAPA
process.
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Increased Oversight
The MasterControl system tracks quality
incidents that can escalate into a CAPA,
such as customer complaints, audit findings,
etc. Provides advanced analytics and
reporting capability, including customizable
reports and online charting. Through the
reports, managers get a real-time view of
the CAPA process and can be more proactive
about improving their quality system. |
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