π οΈ Mason: [Add Change Control Regulatory Impact Assessor]#587
π οΈ Mason: [Add Change Control Regulatory Impact Assessor]#587
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π‘ What: Added a new expert-level prompt
change_control_regulatory_impact_assessor.prompt.yamlwithin theregulatory/qualitydomain. Generated corresponding documentation and index updates.π― Why: Addressed a missing gap in regulatory change control workflows by creating a highly specific prompt utilizing FDA guidelines to evaluate medical device design and process changes.
π Impact: Expands the repository's capabilities with a robust tool to perform regulatory impact assessments, ensuring compliance with 21 CFR 820.30(i) and 820.70(b).
PR created automatically by Jules for task 13524409260682221697 started by @fderuiter