If validation documentation is done earlier, the Factory Acceptance Test (FAT) can be a simple procedure, but not always.
"It used to take only a couple of hours to make sure things were running properly during a factory acceptance test, but today it can take eight to 10 weeks to put the equipment and software through the necessary challenges to demonstrate that it will meet today's quality compliance standards," says Bikash Chatterjee, COO of consultancy Pharmatech Associates.
"We need to make sure that the equipment will meet all the user and functional requirements, which means we spend more time at the factory where it's more efficient to fix things in the supplier's factory than on the customer's shop floor," he says.
"Some customers are doing FATs in factories and are there for weeks on end," says Dave Schuh, VP of sales and marketing at MGS Machine Corp. "But the challenge is to understand the full scope of the FAT requirements, and fit it within the scope of work up front so that everyone wins." July 10, 2005
