Enhancing Data Integrity: A Global Pharmaceutical’s Journey to Operational Excellence and Compliance” Data Integrity Maturity Model Pharmaceutical companies operate in a highly regulated environment where
Ensure data integrity and compliance with Data Flow Mapping (DFM). Discover how DFMs provide a detailed view of data movement, identify risks, and streamline assessments for organizations. Learn why DFM outperforms process flow mapping in safeguarding data quality, supporting regulatory compliance, and improving operational efficiency. Get expert insights from our team today.
In industries where safety, quality, and efficacy are paramount—such as pharmaceuticals, medical devices, biotechnology, and food and beverage—compliance with regulatory requirements is non-negotiable. Ensuring that
In highly regulated industries such as pharmaceuticals, medical devices, biotechnology, and food and beverage, compliance with regulatory requirements is crucial to ensure product quality, safety,
Understanding the Differences: 21 CFR Part 11 vs. Annex 11 Two key regulations that pharmaceutical and medical device companies need to be compliant with are
12 Tips to Help you get Ready for your Quality Audit Audit’s play a vital role in ensuring organisational effectiveness, compliance, and sustainability in a
9 Key Areas for EudraLex Annex 11 Key Areas in Annex 11 EudraLex Annex 11 is a European Union guideline that provides guidance and promotes
SHIFTING THE VALIDATION PARADIGM: From Computer Software Validation to Computer Software Assurance. In 2011 the FDA launched their “Case for Quality”. The FDA were asking
The Value of Screenshots in CSA Screenshots have become a commonly used method for visually communicating information, providing step-by-step instructions, reporting bugs, and showcasing designs.
GAMP5 2nd Edition and CSA (Computer Software Assurance) GAMP – Good Automated Manufacturing Practices was founded in 1991 and is a trademark of the International