InfoCAPA Features

The following matrix summarizes all key elements of a sound non-conformance and CAPA system, and how these are addressed in InfoCAPA.

Element

How Makromed/InfoCAPA Addresses It

A. Vendor Qualification

Quality Commitment & Reputation

  • Makromed adheres to the quality standards of ISO 9001 & ISO 13485.
  • Makromed has been providing software solutions for quality and regulatory compliance to the healthcare industry since 1990.

Quality Performance

  • Makromed welcomes its customers to audit our operations.
  • We maintain a formal Software Development Life Cycle (SDLC) system.
  • All software documents, including software validation plan and report, are open for audits.

B. Basic Features

Up-to-date with Underlying Regulations

  • InfoCAPA lets you maintain a sound non-conformance and CAPA program that meets the requirements of various quality and regulatory standards such as FDAís GMP, QSR, and GTP regulations; ISO 9000 and ISO 13485 standards; and EUís MDD regulation.
  • InfoCAPA allows you to track, investigate and disposition deviant materials.
  • InfoCAPA lets you initiate, investigate, implement, and assess for effectiveness the corrective and preventive measures in your quality system.
  • InfoCAPA tracks and alerts for awaiting items to help ensure timely response.
  • InfoCAPA has enhanced security and audit trail features to address the electronic signature and records requirements of the 21 CFR Part 11 regulation.

Non-conformance Process from Beginning to End

  • InfoCAPA organizes the non-conformance process in a series of phases:
    • Initiate a non-conformance record.
    • Identify the equipment, environment, or material involved.
    • List the specification and the corresponding deviation encountered.
    • Assign and investigate the deviation.
    • Identify the cause of deviation.
    • Decide on the materialís disposition.
    • Implement solution.
    • If needed, escalate to and initiate a CAPA.
    • Close out the non-conformance record.

CAPA Process from Beginning to End

  • InfoCAPA organizes the CAPA process in a series of phases:
    • Review for merit and designate category and priority.
    • Assign investigation tasks and select planned Investigation tools/techiniques ( Process Map, 5 Whyís, Is/Not Is, etc).
    • Conduct root cause analysis.
    • Identify and implement the necessary action.
    • Follow-up and assess its effectiveness.
    • Close out the CAPA record.

Reports and Trends

 

  • InfoCAPA has built-in non-conformance and CAPA forms.
  • InfoCAPA has several built-in reports for tracking and organizing non-conformance and CAPA records.
  • InfoCAPA has built-in alerts for records needing attention.
  • InfoCAPA has several built-in management reports.

C. Support Features

System Configuration

  • InfoCAPAís configuration module provides the following features:
    • User control of business rules to enforce in the non-conformance and CAPA processes.

Access Security

  • InfoCAPA provides an elaborate security system to control user access of security data
    • Administrators with full access
    • Users with full edit rights
    • Users with partial rights (ex: investigators can not edit QA review)
    • ReadOnly users
    • Password rules, encrypted passwords

Audit Trail

  • InfoCAPA maintains a full audit trail of all data editing activities, using the user name and date/time stamp and showing the details of what was created/added/modified/deleted.

D. System Validation

Validation by Makromed

Click here to see the SDLC flowchart

  • Validation performed in accordance with Makromedís SDLC (Software Development Life Cycle).
  • Certificate of Validation is included with the system.
  • All validation documents are maintained at Makromed and are open for audits.

On-site Validation

  • Work templates for Installation Qualification (IQ) and Operation Qualification (OQ) are included with the system.
  • Makromed performs on-site IQ as part of the installation service, and offers on-site OQ.

E. Customer Support & Training

System Customization

  • Makromed can provide customization of InfoCAPA to your specification.
  • All customized features are validated using the same process as on standard system.
  • Customized features are carried forward to future upgrades at no additional cost.

Technical Support

  • On-site installation on any computing environment is provided.
  • 12-months of technical support and warranty is included in the base system.
  • Annual maintenance contract for extended support is available.

Training Seminars

  • 2-day on-site training seminar for end users and administrators.
  • Certificate of Training provided to all attendees.

F. Technical Issues

System Requirements

  • Windows 2005 server or higher; 4GB RAM / 150 MB disk space.

Configurations

  • Web server.†† Users access via URL on Internet Explorer browser

Database

  • InfoCAPA runs on SQL Server database

Email

  • InfoCAPA email notifications thru your SMTP email server.

Copyright © 2013 Makromed, Inc.