»  System Design - ICM's team of Professional Services consultants can make recommendations as to the hardware configuration that best suits your automation needs. If you do not have infrastructure in place ICM will help you acquire what is needed. . Please note ICM does not sell hardware - we work with any hardware platform supported by the Microsoft Windows 2003 operating system.

»  Closed System Design - the FDA recommends the use of a "Closed System" for deploying Part 11 compliant solutions. ICM can help you design this network to meet the FDA guidelines.

»   VIZYX implementation - ICM uses a formal methodology for deploying your solution. The first phase of the deployment is an intensive workshop called a JAD Session. In this session your requirements are defined and documented. The output of the JAD session are presented formally for review and any adjustments to ICM's understanding of the requirements are made. After the JAD process is complete ICM configures and tests as much of the solution in our LAB in order to reduce the deployment impact on our clients. When the solution clears QA, it goes through a Customer Acceptance Phase, where our Client reviews the system to ensure it meet the needs described in the user requirements documentation. Once approved the on-site deployment begins and VIZYX is implemented, test and the solution is re-reviewed before going through the Validation process.

»   System Validation - ICM provides validation services that include the validation of the operating system; database system and VIZYX. The Client is provided with full IQ/OQ/PQ documentation.

»   System Transformation - Clients who elect to move off one platform to VIZYX can make use of the ICM transformation service. This service provides for the migration of data and documents stored in a current system to the appropriate module in VIZYX.

»   System Integration - for Clients wanting to integrate VIZYX into other applications such as SAP; Oracle or others, ICM Integration Services will help facilitate this integration.

»   Post Implementation Support
Once the deployment is up and running, users have been trained and the system is live and validated. There are three levels of support available to our Clients:

»   24 Hour On-line Help-desk - ICM Clients are provided with a unique login and password to access the ICM on-line support site. Here you are able to provide feedback on errors; product improvement ideas; log training requests and other options. Once the ticket is logged it is routed to the a support representative for resolution. Responses to on-line enquiries are usually in the same business day but never longer the 24 hours on weekdays.

»   Telephone Support - depending on your support level agreement (SLA) you have a number of support hours as part of your subscription agreement. You can call the ICM support line and log a ticket on-line. In most cases the support person taking the call will try to resolve the matter with you over the phone.

On-site Support - if you have an on-site support contract with ICM, you can contact ICM through the support-line; via email or the help-desk to request on-site services and or resolution to your question. If your system is Outsourced to ICM your will have access to additional support options, which will be described in your outsource Server Level Agreement. These vary depending on the outsource level.

Outsourcing

ICM provides two types of outsourcing:

»      Traditional Outsourced Solutions
»      System Management options

Traditional Outsourcing
This solution provides for the complete management of your system. ICM provides all hardware infrastructure, software licensing, implementation and support functions for the management of the compliance infrastructure. This service may optionally include the management of existing infrastructure during periods of transition to VIZYX or the management of third party solutions integrated to VIZYX. Please contact ICM form more information

System Management Full Time Monitoring
For companies that provide the infrastructure and networking support for VIZYX, but want ICM to manage all aspects of the day to day operation of the compliance environment. This includes running daily back-ups; system health checks; support; on-going training; database optimization; system upgrades and validation.
Monthly Log Monitoring
For companies who have limited IT resources and want ICM to monitor the health of the system; provide upgrades; on-going support and training. The system checks are performed according to a regular monthly schedule and you are provided with an SOP outlining these activities.

Quarterly Monitoring (includes performing upgrades)
For companies who have IT resources and but want ICM to monitor the health of the system; provide upgrades; on-going support and training. The system checks are performed according to a regular quarterly schedule and you are provided with an SOP outlining these activities.