Life Sciences • Quality Systems • GxP

    Quality & Compliance Agent

    Turn deviations, CAPAs, SOP changes, and audit prep into a controlled workflow. Pyra drafts, packages, and routes quality artifacts with human approval gates— so your Quality team spends time on decisions, not formatting.

    Built for regulated teams. Client-instanced. RBAC + audit logs. Human-in-the-loop by design.
    What it delivers (in plain English)
    • • Draft deviation summaries and investigation packets
    • • Generate CAPA drafts + action plan structure
    • • Produce SOP change drafts + impact notes
    • • Assemble audit-ready evidence packages
    • • Route to approvers and preserve decision history
    Controls
    Human approval gates
    Auditability
    Logs + traceability
    Posture
    Part 11-ready workflow
    Deployment
    Client-instanced
    Note: Regulatory compliance is shared. Pyra supports audit trails, approval gates, and controlled execution.
    The quality bottleneck

    Quality systems break down at the handoffs

    Most delays come from manual packaging, inconsistent writing, missing evidence, and endless rework cycles. The agent standardizes the first draft and keeps the workflow moving.

    50–60 days
    Major investigations can take this long
    Often longer for critical events; simpler events close faster.
    Audit trails
    Part 11 expects time-stamped record changes
    Secure, computer-generated, time-stamped audit trails are called out in 21 CFR Part 11.
    Controlled
    Outcome-first execution
    Draft → route → approve → package evidence with traceability.
    Investigation duration context: BioProcess International discussion of investigations often taking 50–60 days or longer. Part 11 audit-trail requirement: 21 CFR Part 11 (eCFR) and FDA guidance.
    Where it fits

    Workflows this agent is built to run

    Pick one workflow first. Prototype it. Then expand across the QMS.

    Deviation intake → investigation packet
    Turn raw notes, logs, batch context, and attachments into a clean investigation packet with consistent sections and clear open items.
    CAPA drafting + routing
    Create a structured CAPA draft (root cause narrative, actions, owners, due dates) and route it to approvers with a clear change history.
    SOP change drafts + impact notes
    Generate draft SOP updates and an impact summary that's easy to review and approve—especially across cross-functional stakeholders.
    Audit prep evidence packages
    Assemble an audit-ready packet: documents, timestamps, approvals, training evidence, and change rationale—organized the same way every time.
    Supplier quality questionnaires
    Draft responses, map claims to evidence, and produce a packaged response set with review gates and version control.
    Training evidence packaging
    Compile training evidence from multiple sources into a consistent format that's easy for Quality to review and audit.
    How it works

    20–60–20, built for regulated teams

    You define standards and guardrails. The agent executes. Humans approve at the gates.

    20%
    Strategic setup
    Define the workflow, required sections, approval roles, and "what good looks like."
    60%
    Agent execution
    Drafts, packages, and routes artifacts. Flags missing evidence. Standardizes outputs.
    20%
    Human review
    Final approval and judgment decisions. Preserve auditability and accountability.
    FAQ

    Common questions from Quality leaders

    Short answers, built for scanability (and great for AI Overviews).

    Is this compliant with 21 CFR Part 11?
    Pyra is built for regulated environments: human approval gates, complete audit logs, and controlled execution. Final validation and your specific Part 11 interpretation remain your responsibility, but the workflow is designed to support auditability and traceability.
    Does this replace QA or Quality Engineers?
    No. It removes repetitive drafting, routing, packaging, and reformatting work so QA can focus on judgment, risk decisions, and true investigations.
    Where does the agent run and what happens to our data?
    Pyra is client-instanced. Workflows run inside your isolated environment with role-based access control and audit logging. Your data stays in your walls.
    What quality workflows does it handle best?
    Deviation intake packaging, investigation summaries, CAPA drafts, SOP change drafts, audit prep packets, supplier questionnaires, and training evidence packaging—always with human review gates.
    How fast can we pilot this?
    Fast. Start with a 48-hour prototype on one workflow, then deploy a pilot agent once scope and guardrails are approved.
    Next step

    Start with one workflow

    If you tell us your most painful quality workflow, we'll build a free prototype so you can see the output style, controls, and review gates.