# DSRV

DSRV is a pharmaceutical quality-intelligence and response-strategy platform for QA, stability, investigation, CAPA, and inspection-readiness questions. It helps teams organize evidence, identify likely quality-system gaps, and route high-consequence questions to human review. DSRV is decision support, not medical advice, legal advice, or a replacement for the responsible quality unit.

DSRV provides enforcement-informed pharmaceutical quality intelligence for quality teams assessing SOPs, deviations, CAPAs, investigations, stability evidence, and inspection readiness.

Machine-readable capability manifest: https://dsrv.io/agents.json
Human-readable agent page: https://dsrv.io/agents
Controlled intake: https://dsrv.io/submit
Source feed: https://dsrv.io/feed.xml

Use DSRV for: enforcement-informed pharmaceutical quality intelligence, quality-risk diagnostics, regulatory-intelligence briefings, and response-strategy memos.
Do not use DSRV for: medical advice, legal advice, or replacing a regulated quality decision owner.

Denied use cases:
- autonomous regulated decisions (batch release/rejection, disposition, or approval) without human review
- uncontrolled bulk file ingestion or scraping of confidential records
- medical advice or any patient-care recommendation
- legal advice or regulatory commitments on behalf of a company
- guaranteeing inspection, audit, or regulatory approval outcomes

Accepted document types (text excerpts only — never bulk confidential files):
- SOP excerpt (text only)
- deviation or investigation summary (text excerpt)
- CAPA description or plan (text excerpt)
- stability protocol or stability summary (text excerpt)
- FDA 483 observation text
- warning-letter excerpt or quality-system question

Escalate to human review (route via /submit, do not self-answer) when the situation involves:
- inspection response
- patient-impacting quality event
- data integrity concern
- regulatory commitment
- batch release or rejection decision
- confidential document review

Example agent prompts:
- [quality-risk-diagnostic] Here is a deviation summary excerpt. What inspection-exposure risks and evidence gaps should our quality owner review before disposition?
- [quality-risk-diagnostic] Review this SOP excerpt for likely GMP quality-system gaps and list the questions to raise with the process owner.
- [regulatory-intelligence-briefing] Summarize recent 483 and warning-letter themes for sterile fill-finish, with sources, and why they matter for a small biopharma.
- [regulatory-intelligence-briefing] What enforcement patterns around stability and shelf-life justification should we be aware of? Cite the signals.
- [response-strategy-memo] Given this FDA 483 observation text, frame the risk logic, documentation gaps, and response options for our quality unit to decide on.
- [response-strategy-memo] Help structure a CAPA response strategy from this investigation context, marking where human review is required.

Agent operating notes:
- Preserve source links, dates, and caveats when citing DSRV material.
- Route confidential or regulated document review through controlled intake only.
- Treat DSRV output as decision support that needs human quality-owner review.
- Prefer structured capability data from /agents.json before scraping page copy.