Medical Device Process Validation: What are the REAL Odds of Passing?Statistics tell us: (1) Passing a typical 3-lot PQ is not easy; (2) What to do about it. In medical device process validation (IQ OQ PQ)...
Process Validation vs QC Inspection: 5 Differences to KnowThese 5 differences result from their radically different aims and assumptions.
What is the difference between Cpk and Ppk?How they are calculated can have a profound difference in their values for the process.
The REAL odds of passing a Process Validation Statistics tell us passing a PQ is not easy! In validation we’re providing objective evidence the process is capable of successfully...