To help you successfully validate a computer system remember the following:

1. Development Methodology

Select a development methodology that best suits the nature of the system – the risk analysis you do will help decide what level of validation is required. For example, if you purchase the system from a third party vendor you may be able to leverage some of the testing they have already performed to streamline the effort.

2. Capacity and Functionality

Select hardware based on capacity and functionality – vendors and IT personnel will guide this part of the process.

3. Operational Limits

Identify operational limits to establish production procedures.

4. Operational Functions

Identify operational functions associated with the

a. Users,
b. Processes
c. Regulations
d. Company standards
e. Safety requirements

5. Worst Case

Identify and test worst-case production scenarios.

6. Clearly Document

Clearly document the validation process and start by creating a master validation plan to define the effort involved.

7. Written Procedures

Ensure the availability of written procedures to maintain the validated state of the computer system.