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.