Authoring effective investigations and meaningful, measurable CAPAs is critical to a company’s regulatory success. Despite the presence of robust investigation and CAPA procedures, firms are still struggling with investigations that are not comprehensive, not clear, and often cited by regulators as deficient during inspections.
Meridan has developed an Investigator Certification Program that focuses on one-on-one coaching for investigation authors by Meridan Subject Matter Experts. There is no substitute for real-world experience in drafting investigations, gained while working side-by-side with a coach who mentors on how to approach the investigation, investigate root cause and develop robust, measurable CAPAs. Following a period of coaching, the participant’s independently-authored investigations are then graded using a proprietary, weighted formula. After a number of successful, consecutive investigations pass the independent assessment, then the investigation author is certified by Meridan.
Firms that have completed the Meridan Investigator Certification Program have reported significant improvement in the quality of investigations and CAPAs.