QMS

Beyond Human Error | A Framework for Error Prevention and Mitigation
|

Beyond Human Error | A Framework for Error Prevention and Mitigation

Byipharmacist

Errors are not a reflection of individual incompetence but a result of complex interactions between human factors, system design, & environmental influences. We must abandon the naïve belief that BETTER TRAINING will MAGICALLY ERASE ERRORS and instead embrace a holistic approach. The CAPA framework focuses on both PREVENTION and REACTION to errors: PREVENTION: BUILDING A…

Deficiencies in Compliance and Quality Management Systems | FDA Warning Letter

Deficiencies in Compliance and Quality Management Systems | FDA Warning Letter

Byipharmacist

Addressing the recent FDA Form 483 issued to a firm has outlined compliance Concern: A Call for Data Integrity and Accountability – A recent FDA Form 483 issued to a firm has outlined several critical observations that highlight significant deficiencies in compliance and quality management systems where DATA INTEGRITY, RESPONSIBILITY, and ACCOUTABILITY are apparently lacking….