ProPharma Group and The Planet Group announce unified brand and expanded capabilities. Learn more > Improving Patient Health and Safety. At Every Step. From early concept development through each clinical phase, product launch, and commercialization, we partner with pharmaceutical, biotechnology, and medical device clients to tackle complex challenges. We help to ensure regulatory expectations are met, business goals are achieved, and patient health and safety is improved. Comprehensive experience, including these specialized fields: Medical Device and Diagnostic Cell and Gene Therapy Consulting Services Data Integrity Services Careers Language: Cookie Policy This website uses cookies to optimize website functionality, improve user experience, provide social media features, and analyze site traffic. You can at any time change or withdraw your consent from the cookie statement on our website. For more details, check our Privacy Policy. ACCEPT MANAGE PREFERENCES Reject

ProPharma Group and The Planet Group announce unified brand and expanded capabilities. Learn more > Home /Life Science Consulting /Quality Investigations Quality Investigations Quality Investigation and Corrective and Preventative Action (CAPA) Support A key component of any modern quality system in the pharmaceutical, biologic, and medical device industries is the risk-based response to observed manufacturing, testing, and distribution discrepancies, or as the result of product complaints. Good Manufacturing Practice (GMP) regulations and industry guidance all describe the criticality of implementing a structured approach to performing investigations with the intent of determining root cause of the discrepant issue. Determining the root cause is necessary to implement specific and effective corrective and preventative action (CAPA) to remediate and prevent reoccurrence of the issue, and consequently facilitate continuous improvement. ProPharma Group: THE Leading Investigation and CAPA Experts Contact Us PRODUCT LIFECYCLE Expertise at every stage. Development Clinical Commercial HELPFUL LINKS Contact Us Blog Events COMPANY NAME JOB TITLE EMAIL ADDRESS Careers Language: Cookie Policy This website uses cookies to optimize website functionality, improve user experience, provide social media features, and analyze site traffic. You can at any time change or withdraw your consent from the cookie statement on our website. For more details, check our Privacy Policy. ACCEPT MANAGE PREFERENCES Reject