Regulatory Requirements for Networks

The validation of computer networks is clearly important, but how do we go about validating them How much detail is required The FDA gave the following advice in 1983 on the topic of computer networks supporting manufacturing operations [2]  

It is possible under a computer network for manufacturing operations conducted in one part of the country to be documented in batch records on a real-time basis in some other part of the country. Such records must be immediately retrievable from the computer network at the establishment where the activity took place. 

The FDA cites clause 180 in 21 CFR 211 in relation to computer networks, which deals with records and reports for manufacturers of finished pharmaceutical products. The concern is that the computer network must maintain the integrity of data passed through the network. This links to the recent issue of 21 CFR 11 in 1997 which deals with electronic records and their security. Further information on this topic can be found in Chapter 16. 

The UK GAMP Forum provides some advice in their latest guide [3]. Basically, the same validation methodoiogy should be followed as for other automation and IT systems Categorize software components and follow a V life-cycle approach. The GAMP Guide identifies five categories of software  

Configurable software Audit appiication validate application and any bespoke code. 

---