|
MyFDA Academy e-Learning Center
MyFDA Academy e-Learning Center is now online.
MyFDA Academy is an e-learning center where people involved in the medical device, pharmaceutical,
and biotech industries can take online training courses on a variety of topics relevant to the
Quality Management System and/or Regulatory Compliance aspects of these industries.
Check the website out here.
Back to Top
InfoMed - Complaint Handling and Adverse Event Reporting
Software Version 9i - Complaint Handling and Adverse Event Reporting
Software Version 9i with Full eMDR Support
InfoMed version 9i is now available
with full eMDR support.
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.
Back to Top
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.
Back to Top
InfoAudit - Internal and Supplier Audit Software, New Standards
InfoAudit 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.
In addition, the FDA's GTP Tissue Audit template is now
available for use in InfoAudit.
Back to Top
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
Back to Top
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.
Back to Top
InfoPV - Process Validation and Test Method Validation
Software
InfoPV version 10i is now
available. InfoPV is a comprehensive software
solution for managing both process validations and test method
validations in accordance with the FDA's 21 CFR Part 820.75 regulation
and ISO 13 485 standard.
- InfoPV 10i provides a holistic approach to process
validation, starting with a high level view of the entire
manufacturing line for a product family and then zooming into the
individual process steps involved.
- It management of all validation activities to
establish that the process consistently produces an output that
meets predetermined requirements and the overall manufacturing line
produces a product that meets the finished product requirements.
- Click here for
more information.
Back to Top
|
