Computerised systems depend on infrastructure consisting of servers, cabling, routers, switches, workstations and therefore process quality. IT Infrastructure Qualification is essential with validated computerised systems, it supports validated systems, but also business critical applications not regulated, the infrastrusture must guarantee reliability, safety and resilience.
Many service interruptions are related to bad parameter settings, these can be avoided using a good configuration management system. However it is important to note that IT Infrastructure qualification is not a completed in a single push, and the management of configuration changes represents the majority of the work.
It is also worth remembering that regulatory inspections focus more and more on process and data flow, leading to more questions about IT Infrastructure.
IT Infrastructure qualification makes it possible to improve your IT deparments' understanding of the regulatory requirements.
Thanks to IT specialists trained in validation, 21 CFR Part 11, and ITIL; we are able to develop standards based, pragmatic approach to qualifying your IT Infrastructure.
Within this framework we are able to set up new or suppliment existing procedures (Support Management, Change Management, Configuration Management, Disaster Recovery, Access Management etc).
Our Consultants are certified by several major manufacturers and will be able to qualify your hardware storage configuration (SAN solutions, FibreChannel, etc).
A summary of our services:
 |
| a. IT Infrastructure Qualification Plan |
| b. Network Qualification (equipment, protocols) |
| c. Qualification of the server room |
| d. Server / Workstation qualification |
| e. Operating System Qualification |
| f. Change and Configuration Management |
| g. Business Continuity planning |
| h. Managing support, Help Desk, Incidents |
 |
| a. ITIL Evaluation process |
| b. Delegation of Managing ITIL |
| c. Qualification of support Tools for ITIL Processes and Recordings (CMDB in particular) |
| d. Assistance to complete work |
ADN also has technical expertise for the implementation and qualification of digital signatures (in particular, on the deployment of PKI architecture associated with X 509 certificates). This is particularly useful technology for implementing controls for open systems as we can create a compliant VPN for use with systems using electronic signatures or electronic records.
