To provide the FDA regulated companies an easy and reliable technical remediation solution, Xyntek has developed a set of configurable software modules, ITX-CM©, that facilitates and expedites compliance of your software applications with 21 CFR Part 11 practices by providing security, audit log generation, process control, and E-signature capture. The ITX-CM© is provided with a compliance database, which acts as a central repository for all the modules. However, ITX-CM© provides a flexible means to allow other databases to be substituted depending on the corporate standards or the application.
By integrating ITX-CM© with your application, you will be able to
- Eliminate paper records
- Secure system and system related files from unauthorized access
- Maintain Audit Trail for all the activities
- Use Electronic Signatures for acknowledgement of specific tasks
- Exchange information easily and conveniently with an Enterprise Resource Planning (ERP) system
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