OUR SERVICES

IT Quality, Compliance & Regulatory Readiness

Sunny Consulting helps pharmaceutical organizations establish practical, risk-based IT Quality programs—and provides the hands-on expertise needed to implement them.

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Quality Management Systems (QMS)

“Our IT Quality processes aren't working the way they should.”

STRATEGIC

Strengthen the Framework

Assess IT Quality processes and their alignment with the broader Quality Management System to identify gaps, unnecessary complexity, inconsistent practices, and unclear accountability. Define a practical, risk-based approach for strengthening IT Quality processes, governance, roles, and integration with the enterprise QMS.

TACTICAL

Put the Process in Place

Facilitate process workshops and develop or revise procedures, work instructions, process flows, templates, RACI models, training materials, and implementation plans. Support process rollout, stakeholder training, adoption, and establishment of appropriate measures to ensure the process continues to operate effectively.

CSV / Computer Software Assurance (CSA)

“Our validation process is too complicated—and we're spending too much time on things that don't add value.”

STRATEGIC

Modernize the Approach

Assess existing CSV practices and develop a practical, risk-based validation strategy aligned with CSA principles, regulatory expectations, and industry guidance. Identify opportunities to reduce unnecessary effort, focus assurance activities on patient safety, product quality, and data integrity risk, and establish scalable governance across the system lifecycle.

TACTICAL

Execute the Validation

Support system-specific validation and assurance activities, including validation planning, risk assessments, requirements, test strategies and scripts, traceability, summary reporting, periodic reviews, and other lifecycle deliverables. Help project and system teams apply the organization's CSV/CSA approach consistently while maintaining the validated state.

Data Integrity

“We're concerned about our data integrity risk—but where do we start?”

STRATEGIC

Understand & Prioritize the Risk

Assess organizational, process, or system-level Data Integrity risk and help determine where attention is most needed. Establish risk-based assessment and remediation strategies, governance, prioritization, escalation, and sustainable oversight approaches aligned with regulatory expectations.

TACTICAL

Assess & Remediate

Perform or support system and process Data Integrity assessments, document gaps and risks, develop remediation plans and CAPAs, coordinate remediation activities, and support evidence collection and closure. Establish practical tracking and reporting mechanisms to provide visibility into remediation progress and remaining risk.

Inspection Readiness

“We have an inspection coming. Are our IT systems and teams ready?”

STRATEGIC

Prepare for the Inspection

Evaluate IT inspection readiness and identify areas of potential regulatory exposure before the inspector does. Develop an IT inspection-readiness strategy that addresses system compliance, documentation, governance, escalation, likely areas of inquiry, and preparation of the people who may need to represent IT during an inspection.

TACTICAL

Get the Team Ready

Conduct readiness assessments and mock inspection activities; prepare SMEs for potential questions; review supporting documentation; organize evidence and system information; identify and address gaps; and support inspection-room activities, responses to inspector requests, and follow-up actions.

Compliance Remediation

“We know we have a compliance problem. We need help getting it under control.”

STRATEGIC

Define the Path to Compliance

Assess the issue, associated risk, scope, and underlying drivers to establish a practical remediation strategy. Define priorities, governance, accountability, resources, escalation mechanisms, and an executable roadmap that addresses immediate compliance concerns while working toward a sustainable solution.

TACTICAL

Drive the Remediation

Perform or coordinate gap assessments, develop remediation plans and CAPAs, establish workstreams and tracking mechanisms, coordinate cross-functional execution, monitor commitments and evidence, develop metrics and dashboards, and support documentation and sustainable closure of remediation activities.

IT Quality Governance

“We have the processes—but we don't have enough visibility, accountability, or consistency.”

STRATEGIC

Establish the Operating Model

Assess how IT Quality decisions, risks, compliance issues, and performance are governed across the organization. Design or strengthen the operating model, decision rights, governance forums, roles and responsibilities, risk escalation mechanisms, performance measures, and executive oversight needed to create consistent accountability.

TACTICAL

Make Governance Work

Establish governance forums and operating rhythms; develop charters, RACI models, agendas, decision and action logs, KPIs/KRIs, dashboards, compliance metrics, and management reporting. Facilitate governance activities and help teams establish sustainable processes for monitoring risk, commitments, performance, and accountability.

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