Documentation still key in computer validation faults.

ORLANDO -- FDA inspectors are finding that the new technology allowing computer validation has not eliminated the same old problems - sufficient support data and documentation, officials told PDA's spring conference here March 2.

"We are still seeing a lot of problems with the actual validation documents," said Paul Figarole, an FDA consumer safety officer based in Tampa, FL. "It is the same old tale."

Martin Katz, an FDA compliance officer based in Longwood, FL., said the agency still has "to work out how we are going to site" problems with electronically submitted validation information. But, he said, that doesn't mean companies shouldn't already be compiling the appropriate data.

Figarole said during an inspection he wants to see "a plan, a document that says what you are going to do and why you are going to do it."

He said it's important to document the credentials of the person who is responsible for the testing. Assigning the task to the person in the office who is most knowledgeable about the personal computer he uses at home is not good enough, he said.

"I am going to be looking at whether the person is qualified," he said.

Figarole also said it is important to explain why you have chosen a specific test method. "You need to have some reason," he said, "many times we don't see the 'why'."

"Part of your job is to convince me" that sufficient effort has been made, Figarole said. The FDAer said that in his experience, "generally equipment is not the problem; problems occur more on the software end."

And, he said, do not count on the vendor's assurance that they have checked out the software.

"You have to do some work," he said, "You can't rely on that vendor." Ultimately, he said, the manufacturer, not the vendor will be held responsible if something goes wrong.

At the very least, Figarole said, a company should evaluate in writing any validation plan presented by the vendor.

"Have some documentation that shows you have thought about it," he said. Katz also cautioned vendors to protect themselves if a client decides not to thoroughly validate the software.

"If the client declines to do validation," he said, "get it in writing. Have some documentation to back it up."

Figarole said companies sometimes take shortcuts in documenting validation because of the time and money involved.

But, he added: "It is going to cost time and money to correct something that went wrong, so there should be enough time and money to do it right in the first place."