In GxP environments, speed only matters when you can prove control. Pyra agents help teams reduce manual effort in Quality, Regulatory/Clinical Ops, Medical Affairs enablement, and Commercial Ops—while keeping approvals human-owned.
Each agent is built for a specific workflow and deployed with governance: role-based access, human review gates, and audit-friendly operation. Part 11 includes expectations like secure, time-stamped audit trails for record changes.
Drafts controlled documentation, assembles evidence packs, builds audit-ready summaries, and standardizes repeatable quality workflows.
Evidence packaging, submission support workflows, controlled summaries, and review-ready artifacts—built around traceability and approvals.
Builds MSL-ready briefs, medical information drafts, and Q&A support using controlled sources, then routes for approval.
We design for "control first": your team sets scope and guardrails, the agent executes the repeatable work, and humans approve the outcome. Regulators are increasingly publishing principles and guidance for responsible AI use, which makes traceability and governance non-negotiable.
Pyra automates controlled, repeatable operational workflows—quality documentation support, evidence packaging, audit prep, controlled content workflows, and commercial ops enablement—while keeping humans in approval control.
Pyra workflows are designed around governance: role-based access, traceable actions, and audit-friendly operation. Part 11 includes expectations like secure, time-stamped audit trails for record changes and retention aligned to the record lifecycle.
Pyra can draft and assemble content, but final approvals remain with your Medical/Legal/Regulatory process. We bias toward controlled sources and approved repositories to reduce risk.
Regulators are actively publishing principles and guidance for responsible AI use across the drug lifecycle. The direction is clear: use AI, but prove control, traceability, and patient safety posture.