Compex S.A. 2/22/99 Muscle and nerve stimulation devices
2. Failure to validate computer software for its intended use according to an
established protocol, when computers or automated data processing systems are
used as part of production or the quality system, as required by 21 CFR 820.70(i).
For example, your firm failed to validate the software (TEST C2.EXE) used during
finished-device testing. Devices are released for commercial distribution based on
these tests.
