InfoMed - Complaint Handling and Adverse Event Reporting Software Version 9i
InfoMed version 9i is now available.
Version 9i is a full web application and offers many enhancements over Version 8, such as workflow rules, improved email notifications, enhanced reporting and trending, etc. Click here to view some of the features. For more information, please contact us at support@makromed.com.
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InfoCAPA - CAPA and Nonconformance Software Version 9i
InfoCAPA version 9i is now available. InfoCAPA allows you to manage non-conformance and Corrective/Preventive Action programs within your quality system.
Version 9i is a full web application and offers many enhancements over Version 8, such as workflow rules, email notifications, enhanced reporting and trending, etc. For more information, to schedule a demo, or to request access to a trial system, please contact us at support@makromed.com.
For more details on the features and workflow of InfoCAPA, you can also click here.
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InfoAudit - Internal and Supplier Audit Software, New Standards
We have added several new audit checklists in InfoAudit to help streamline your auditing functions with the evolving quality and regulatory standards. These include:
- Part 11 Electronic Records and Electronic Signature
- FDA's Software Validation Guidance
- ISO 13485 Quality Standard
- FDA's Good Tissue Practice Regulation
In addition, the FDA's GTP Tissue Audit template is now available for use in InfoAudit.
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Web-Enabled InfoSuite Architecture
Do you want to install InfoSuite as a thin-client system? Would you like to be able to make all system updates and changes from the server, while also benefiting from increased performance, especially for remote users? Then InfoSuite's web-enabled capability is right for you! This setup will work with either Citrix or Terminal Server.
Click on the link below to see a diagram (PDF format) of the web-enabled architecture.
Web-Enabled InfoSuite Architecture
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Part 11 Compliance Assessment Services
We now provide Part 11 compliance assessment service for your electronic records- and electronic signature-based quality system. For any system or sub-system, we would undertake the following:
- Using the current FDA's guidance document, determine if the Part 11 requirements apply to the system.
- Conduct and document risk assessment to justify not implementing Part 11 controls, where appropriate.
- Conduct Part 11 gap analysis and recommend specific actions to make the system Part 11 compliant.
- Conduct formal Part 11 compliance audit throughout the organization.
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