Network Qualification

It is important to understand the difference between Validation and Qualification when bringing a company wide network or a local production network into a state of control and a compliant state. A process is validated and equipment is qualified. Many new regulations have emerged; the EU GMP guide - Annex 15, ICH's Annex 18, 21 CFR Part 11, and others that correspond to qualification of the network infrastructure and the validation of the software that resides there. Recent regulatory action has brought to light the need to have clear separation of systems and understanding where one system ends and the next begins. Controlled configuration management and qualifying the data migration is important and will keep you away from a painful learning experience that some call "garbage in - garbage out". Setting up a system to assure a state of control, bring a network into a compliant state, and network qualification and related validation is our specialty.

We can assist in many areas; some of these are defined below:

Project Management activities and assisting with a compliance strategy
Qualification of the Network Infrastructure
Network Diagrams - Defining the system and its boundaries
Criticality Assessment - defining what systems and software should be validated based on business,
compliance, product and health risks.
Validation of the software applications and databases
Define the open/closed systems and validate accordingly.
Construct a quality system for you infrastructure operations - Directives, Policies, Guidelines, and Procedures.