OUR SERVICES

IT Risk, Resilience & Recovery

We help organizations understand operational and compliance risk, prepare for disruption, and provide experienced leadership when critical regulated operations need to recover.

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IT & GxP Risk Management

“We know we have risks—but are we focused on the right ones?”

STRATEGIC

Understand & Prioritize the Risk

Assess IT and GxP operational risks and establish a practical, risk-based approach for prioritization, governance, escalation, mitigation, and leadership oversight. Help focus organizational attention and resources on risks that could meaningfully affect compliance, data integrity, product quality, or critical operations.

TACTICAL

Make Risk Visible & Manageable

Facilitate risk assessments and workshops; develop risk registers and prioritization criteria; establish mitigation plans, ownership, and escalation mechanisms; track actions and emerging risks; and develop metrics, dashboards, and reporting to provide leadership with ongoing visibility.

Business Continuity Planning

“If something happens, can we keep critical operations running—or get them back quickly?”

STRATEGIC

Prepare Before It’s Needed

Assess continuity needs for critical GxP systems and technology-dependent processes and establish practical strategies for maintaining or restoring essential operations following a disruption. Define priorities, roles, critical dependencies, governance, and recovery considerations across Business, Quality, IT, and technology partners.

TACTICAL

Build the Plan

Facilitate business continuity assessments and planning workshops; identify critical systems, processes, dependencies, and stakeholders; document continuity and recovery plans; establish roles, communications, and escalation paths; coordinate readiness activities; and support exercises and updates to keep plans relevant.

Operational Resilience

“How prepared are our critical operations for a major disruption?”

STRATEGIC

Identify the Vulnerabilities

Assess how critical regulated operations could be affected by technology failures, external events, or other significant disruptions. Identify key vulnerabilities and dependencies and define opportunities to strengthen preparedness and the organization’s ability to maintain or restore critical operations.

TACTICAL

Strengthen Readiness

Map critical processes, systems, dependencies, vendors, and stakeholders; facilitate scenario and readiness discussions; identify gaps and improvement opportunities; establish actions, ownership, tracking, and reporting; and coordinate cross-functional activities to strengthen operational resilience.

Crisis & Recovery Leadership

“Something significant has happened. We need experienced leadership to help get this under control.”

STRATEGIC

Establish the Recovery Path

Quickly establish priorities, governance, decision-making, stakeholder alignment, and a coordinated recovery strategy following a significant disruption affecting regulated systems or operations. Bring Business, Quality, IT, vendors, and leadership together around a clear path toward restoring critical capabilities.

TACTICAL

Lead the Recovery

Provide hands-on program leadership during the recovery. Establish workstreams, priorities, governance, risk and issue management, status reporting, and executive communications; coordinate cross-functional teams and technology partners; and track.

GxP System Recovery & Requalification

“The technology is coming back online—but how do we safely return it to GxP use?”

STRATEGIC

Define the Return-to-Operation Approach

Develop a risk-based strategy for recovering GxP systems following a significant disruption. Establish system priorities, Quality oversight, validation and requalification expectations, governance, and criteria for determining when systems are appropriate to return to regulated operations.

TACTICAL

Coordinate the Return to GxP Operations

Coordinate system assessments, validation and requalification activities, documentation, testing, issue resolution, Quality review, evidence collection, and status tracking needed to support the compliant restoration of GxP systems and return to operations.

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Sunny combines strategic guidance with hands-on execution, so the work does not stop at recommendations.

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