Add-On Modules (bolt on to any package)

• CSA for Analytics Pipelines (NGS/PV/HEOR): URS → risk assessment → test scripts → traceability for data/compute lineage

• Human-in-the-Loop Design: decision thresholds, escalation rules, reviewer checklists

• HEOR/Value Dossier Support: time-to-task, error-rate, and utilization metrics to quantify benefit

• Vendor & Model Assessment: rubric-based evaluations (hosted LLMs, embeddings, retrieval stacks)

• SOP Refresh: CSV/CSA alignment, monitoring-light SOPs, log-retention and access controls

• Training & Enablement: 2-hour workshops for QA/IT/R&D; “how to read the evidence” for stakeholders

• Tool Qualification

  • Scope: Risk-based Part 11/CSA checks for your platform (Ketryx/Sware/Jira/SharePoint): e-sig/audit trail, URS↔traceability, roles/segregation, backup/restore, identity preservation in integrations.

  • Deliverables: Mini-URS, supplier-leveraged assessment, targeted OQ/PQ scripts, executed evidence,

  • Validation Summary Report, periodic-review cadence.

  • Who cares: QA/CSV + IT/Sec