VENTURE CAPITAL DUE DILIGENCEQuality systems & compliance
RCRI® understands global quality and compliance requirements and has significant experience creating quality systems that comply with FDA regulations as well as those of the European Union, Japan, Canada, and Australia.
RCRI will analyze and assess current:
- Quality systems (QSR/GMP/GLP/GTP).
- SOP systems and instructions
- ISO compliance.
- Inspection history and regulatory actions including outstanding actions.
- Regulatory submissions.
- Labeling compliance.
- Postmarket surveillance activities (complaints, MDRs, and annual reporting.)
- 21 CFR Part 11 audits.
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