Trend analysis is especially useful for monitoring process, product performance, changes, improvements and activities directly or indirectly related to pre-market and post-market. These assessments are directly connected with quality management system and risk management decisions, primarily those to determine whether an issue should be escalated to a formal corrective and preventive action (CAPA), signal management sometime followed by design changes.
Frequent trend analysis can have an extensive optimistic outcome over manufacturing, testing and release, including personnel activity, handling techniques and written measures. Trend analysis should be part of the periodic and annual product / process review with help of applicable statistical tools and software to verify and validates the process is robust. Download whitepaper to continue reading.