# SOPhIA-QA - SOP Foundation Platform for Life Sciences SMEs

> SOPhIA-QA helps life-sciences SMEs and startups create QA-review-ready SOP drafts, forms, and regulatory evidence handoff material before audits, diligence, submissions, or partner qualification.

## About SOPhIA-QA

SOPhIA-QA is an AI-assisted SOP foundation platform for Biotech, MedTech, CRO, lab, and regulated-service teams. It is not an eQMS and does not replace qualified QA/RA review, approval, document control, training, CAPA, audit, or change-control systems.

SOPhIA-QA is operated by Binoron, LLC, a Delaware limited liability company:

Binoron, LLC
1111B S Governors Ave # 47095
Dover, DE 19904
United States

## Key Features

- **SOP foundation builder**: Create structured SOP drafts from regulator-aware templates
- **SOP Readiness Analysis**: Free analysis to identify likely SOP foundation gaps
- **Regulatory evidence support**: Surface sources, freshness, and review status for human verification
- **GxP- and ISO 13485-aware templates**: Drafting support for life-sciences quality workflows
- **Export to DOCX/PDF**: Handoff drafts for review and implementation

## Target Audience

- Biotech startups and SMEs
- MedTech startups and SMEs
- Contract Research Organizations (CROs)
- Lab and regulated-service providers
- Life-sciences teams building a SOP foundation before a full eQMS is needed or affordable

## Supported Context

- GxP: GMP, GDP, GLP, GCP
- ISO 13485 context for medical devices
- ICH, FDA, EMA, MDR/IVDR, and related regulatory evidence where validated sources are available

## Important Limitation

SOPhIA-QA outputs are drafts. Customers must adapt, verify, approve, and control documents through qualified QA/RA personnel and their own quality system.

## Contact

- Website: https://sophia-qa.com
- Email: support@sophia-qa.com
- LinkedIn: https://www.linkedin.com/company/sophia-qa

## Documentation

- Blog: https://sophia-qa.com/blog
- AI Governance: https://sophia-qa.com/ai-governance
- Legal Notice: https://sophia-qa.com/legal
- Privacy Policy: https://sophia-qa.com/privacy
- Terms of Service: https://sophia-qa.com/terms
- Cookie Policy: https://sophia-qa.com/cookies
- Refund, Cancellation, and Subscription Policy: https://sophia-qa.com/refunds
- Subprocessors: https://sophia-qa.com/subprocessors
- Accessibility Statement: https://sophia-qa.com/accessibility