We still need to prepare for testing by writing protocols that demonstrate all the requirements have been fulfilled and can be repeated if ever necessary.

Historical Approach to Validation

We’ll first look at the historical approach to validation, then drill down into protocol writing aspects, then finally talk about executing tests.

Let’s first get a few terms straight:

• Testing – only tests the software
• Qualification – verifies that a segment of the system is capable of performing its required function
• Validation – verifies that the entire process is capable of performing its required function (as per the predetermined requirements) and that a ‘state-of-control’ exists for the entire operation.

Our goal, as you may have concluded, is validation; not just testing or qualification, so keep that in mind throughout this section.

Quality Cannot Be Tested into Software

And never forget: quality cannot be tested into software.

Validation confirms that a quality process exists – from system initiation, development, implementation, operation and retirement.