Everybody’s operating under a tighter budget these days. “Lean
government” has become a buzzword. Even the politicians finally seem to
have noticed lean processes that manufacturers have been studying and
implementing for decades.
The FDA has noticed, too.
To serve the FDA’s objectives of efficiency, consistency and
effectiveness, industry is being asked to revisit the way that processes
are developed and documented – standardizing the enormous amounts of
product data that manufacturers send in. Ever more responsibility is shifting to the medical device industry to track data on its outsourced supplies.
With accurate and comprehensive computer-aided inspection (CAI) you can
satisfy regulators by recording and documenting every surface data
point and every extracted dimension for future reference.