Data Sheet
1
Data Sheet
MasterControl Field-Based
Solutions (FBS) CAPA™
If launching a formal corrective action preventive action (CAPA) is the only tool at
your disposal to handle quality issues, your company is at risk of experiencing the
proverbial death by CAPA – if it isn't already. To avoid this, quality management
systems must support an objective approach to triaging quality issues and events.
MasterControl FBS CAPA™ is a flexible, configurable best practice process
solution that provides you with the option to initiate an issue review to evaluate
a quality event using the FBS Issue Review form, or if needed, escalate directly
to CAPA using the FBS CAPA form, depending on your company's business risk
policies. Because FBS CAPA is built on MasterControl's common platform and
integrates with the full FBS Library of process solutions, you can easily assign
and launch action items, such as data gathering as part of your root cause
investigation or specific remediations as part of your CAPA plan. You can also
initiate any required document revisions directly from the FBS CAPA form. And
thanks to the interconnectedness of MasterControl's process solutions, all actions
taken to address a quality event and the rationale behind them are automatically
recorded and tracked in the system, providing a digital audit trail that streamlines
the audit process.
Development Clinical Regulatory Quality Supplier Manufacturing Postmarket
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