Medical stamping validation is a different world from automotive. We run catheter components and spinal implant blanks on a 110T servo press and the documentation burden is real but manageable if you set it up right from the start.
Biggest lesson: build the validation protocol around the force curve, not just dimensional inspection. FDA auditors love seeing that you monitor the process signature on every single stroke. We set force curve envelopes with upper and lower bounds at 10 crank angle positions through the forming zone. Any stroke that falls outside the envelope triggers an automatic part divert and alarm. In 3 years of production we have had zero escapes to the customer.
For the IQ/OQ/PQ cycle: do not skip the thermal stability study during OQ. Run the press for 4 hours at production speed and log force and dimensional data every 15 minutes. Medical parts are tight enough that the 0.01-0.02mm thermal drift matters. We found our press needed 45 minutes to stabilize, so the first 200 parts of every shift go through 100% CMM inspection instead of the normal sampling plan.
On data retention: we store raw force curves in binary format, about 1.5KB per stroke. At 40 SPM running 16 hours/day that is roughly 35GB per year. We keep 10 years online (FDA wants 7 but our quality team wants margin). A simple SQL database with the stroke timestamp, part serial, and a pointer to the binary file works fine. Do not try to store the curves as CSV in the database, the storage bloat is 10x.