MONITORING 'KEY' TO SUCCESSFUL OUTSOURCING, EXPERT SAYS

Skilled use of outsourcing can save drugmakers money, time and headaches, but it doesn't absolve them of ultimate responsibility for their product and data, a former FDA official said.

With the use of outsourcing for many functions expected to increase, former Special Assistant to the Associate Commissioner for Regulatory Affairs and now EduQuest President Martin Browning warned companies to remember to carefully vet their partners and conduct ongoing monitoring after the real work has begun. However, don't rely too much on audits, he advised. "Those are a snapshot in time only," he said. In fact, audits alone are a "very poor" way to keep tabs on a company's outsource partners' performance, he stressed during an Aug. 31 audioconference sponsored by FDAnews.

"Diligent monitoring is the real key to maintaining quality and a better way to assess the health of a company," Browning said.

An effective monitoring program should be in writing, he said. Companies must also train their employees and make certain the outsourcing partner understands the requirements -- technical and regulatory, among them -- of the company and the FDA. "Constantly measure compliance."

Monitoring is particularly important in the area of IT outsourcing, an area that is likely to grow faster than most, he noted. "If you outsource IT, you are still responsible for assuring that all required activities are performed and documented," Browning said.