Regulatory Impact Assessment
Everything an assessor needs. Nothing they don’t.
Each capability addresses a distinct phase of assessment execution working together within a single isolated workflow.
Structured workflows, deep control evaluation, evidence integrity, and audit-ready reporting in one enterprise
regulatory assessment tool.
Structured Assessment Execution
- Framework-Tailored: Methodology-driven phases (plan, scope, assess, report).
- Defined Completion Criteria: Activity tracking with strict dependency controls.
- Deep Control Evaluation: Evidence integrity mapped within isolated workflows.
Audit-Ready Governance & Visibility
- Real-time Tracking: Progress visibility across controls, phases, and open RFIs
- Parallel Execution: Progress visibility across controls, phases, and open RFIs.
- • 3 Audit-Ready Deliverables: PDF report, action matrix, and compliance note.
4 Phases
Plan, Scope, Assess & Report
3
Deliverables
Report, Action Matrix & Compliance Note
100%
Audit-Ready Workflow Isolation
1 Platform
End-to-End Control Assessment
Core Capabilities
Assessment Execution Built for Precision
Explore how Vistaar’s compliance impact assessment software drives control evaluation, evidence integrity,
and reporting across life science companies , including pharma, biotech, Consumer Health,
and medical devices regulatory impact assessment initiatives.
Structured Workflows
Every assessment follows a framework-specific methodology, not a generic checklist. Every step an assessor needs to complete is captured within the regulatory impact assessment workflow. Nothing happens outside of it. Assign team members to specific phases or activities, track dependencies, and ensure regulatory assessment audit readiness so nothing is missed.
- Framework-tailored phases: plan, scope, assess, and report
- Completion criteria and dependencies on every activity
- Assign assessors to phases, objectives, or activities for parallel work
- Fully trackable: progress across phases, controls, reviews, and open RFIs through systematic regulatory assessment tracking
Area specific Phases
Each area, regulation, or guidance has its own phased methodology that mirrors how assessors actually work.
- Capture engagement details, team roles, milestones, and methodology upfront
- Define the boundary: classification, environments, stakeholders, external services
- Assess controls through multiple organized views, not one flat list
- Produce reports with narrative sections alongside auto-populated control data
Smart Control Views
Control assessment is organized into distinct views so assessors can focus on what matters right now. Filter controls by who’s responsible, which guideline they belong to, their current status, or whether they’re waiting on any response. Each view shows only the relevant controls with the right context.
- By responsibility: assess System Owner controls separately from Consumer or Provider
- By guidance: work through one guideline or mitigation strategy at a time
- By approval status: review everything that’s ready for sign-off in one place
Everything Connected
Capture external service dependencies in scoping, and the system flags controls needing responses during assessment. Everything an assessor needs to produce the final deliverable is within the workflow.
- External services identified in scoping trigger information request activities during assessment
- Ineffective controls prompt assessors to add recommendations before progressing
- Report narrative sections display related control data, evidence, and guidance
- Three deliverables generated from one assessment: PDF report, action matrix, compliance note
Realtime Progress Tracking
Assessment leads see the full picture without chasing team members. How many controls are assessed, how many are pending review, which requests are still open, and where each phase stands. The workflow is fully trackable from start to finish.
- Phase, objective, and activity completion tracked in real time
- Control status breakdown: assessed, pending review, open requests at a glance
- Multi-assessor visibility so leads can spot bottlenecks early
- Click any metric to jump directly to the filtered view
Automated Workflows
Streamline Risk Assessments with Automated Workflows
Easily streamline and automate assessments – plan, schedule, manage, and perform assessments – using Vistaar.
Book a demo to see how Vistaar replaces manual checklists
with structured, audit-ready assessment workflows.
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FAQ’s
Find answers to frequently asked questions about Vistaar’s Risk Assessment software.
Let's talk about how Vistaar can help you