InfoCAPA

Available Now: InfoCAPA 9i

CAPA (Corrective and Preventive Action) and Nonconformance Software

CAPA Software

 Web application

Access it from anywhere with a PC and a browser

Comes with flexible hosting options - on our servers or yours.

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. In the CAPA module it lets you initiate a request for CAPA, 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 9i.
  • 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

Click here to download a brochure on InfoCAPA 9i CAPA and Nonconformance Software.