QMS

QMS in Pharmaceuticals Industry

QMS in Pharmaceuticals Industry

In the pharmaceutical industry, quality is more than a goal—it’s a responsibility. At the heart of this responsibility lies the Quality Management System (QMS). A well-designed QMS ensures that every product is safe, effective, and compliant with regulatory standards. Key QMS tools driving success in pharma include: Risk Management Quality Risk Management is a systematic…

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

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

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….