Available Now: InfoCAPA 10i
CAPA (Corrective and Preventive Action) and
Nonconformance Software
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Web application
Access it from anywhere with a PC and a browser
Comes with flexible hosting options - on our servers or
yours.
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Contact us at info@makromed.com
or 603-890-3311 x300 to conduct a convenient interactive evaluation now, using
your existing PC with no demo programs or anything else to download.
InfoCAPA CAPA and Nonconformance
Software helps you manage nonconformance and CAPA programs in support of
your quality system. It provides two distinct workflows for the
nonconformance and CAPA processes. In the nonconformance module, it lets
you initiate, investigate and disposition deviant materials, and
undertake the corresponding corrective actions. If determined, you can
escalate the nonconformance to a CAPA. The CAPA module will allow user to
assign and investigate it, conduct root cause analysis, implement the
action identified, determine the effectiveness of the action, undertake
follow-up assessment, and finally close out the CAPA.
General
- Long and impressive list of powerful business rules for
email alerts, workflow enforcements, and closing conditions.
- Extensive and distinct workflow logic for both
nonconformance and CAPA processes.
- Long and impressive list of powerful features, many of them exclusive to InfoCAPA 10i.
- Comes with a certificate
of Part 11 compliance and validation and with on-site
installation/validation documents.
Regulatory
Compliance
- Comply with FDA’s GMP/QSR regulations.
- Comply with European Union’s Medical Device
Directives (MDD).
- Meet the requirements of international quality
standards such as ISO 9000 and ISO 13485.
Nonconformance
Process
- Track deviant materials
- Investigate and disposition deviant materials
- Initiate corresponding CAPA or other actions to
address the nonconformance
CAPA Process
- Initiate CAPAs
- Investigate and conduct root cause analysis
- Implement the action identified
- Determine the effectiveness
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