This case study examines how a leading global pharmaceutical and medical device company leveraged Information Mapping methodology to optimize and align their quality system documentation and risk management processes with ISO 14971.
Facing challenges related to information overload, lack of structure, and misaligned processes, the company undertook a documentation overhaul. Through analysis of current documentation, collaborative design sessions, and structured writing, they transformed their Risk Management SOPs to improve clarity, emphasize ISO standards, and enhance overall quality and compliance.
The results included increased efficiency, reduced training time, improved knowledge retention, and sustained regulatory adherence.
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