Tag: software validation for medical device manufacturing

Risk-Based Approach to Vendor Qualification

Risk-Based Approach to Vendor Qualification Risk-Based Approach to Vendor Qualification In the pharmaceutical and medical device industries, the qualification of vendors and materials is a critical component that ensures product quality and compliance with regulatory requirements. The FDA, EMA, and…

Step-by-Step Guide to Designing Swab Sampling Locations

Step-by-Step Guide to Designing Swab Sampling Locations Step-by-Step Guide to Designing Swab Sampling Locations In the pharmaceutical and biologics sectors, swab sampling is an essential aspect of ensuring that manufacturing equipment is adequately cleaned and sanitized. Proper swab sampling techniques…