Enterprise Technology & Validation Consulting

Experienced consulting for complex systems, regulated environments, and critical business change.

Sudita provides senior-level consulting across software validation and verification, ERP implementation and support, project recovery, data migration, systems integration, business process improvement, AI adoption, and fractional technology leadership.

Consulting Services

Senior-level consulting built around business outcomes

Sudita is positioned to solve larger business and technology challenges—not simply sell isolated tasks. Each engagement can draw on a broad set of delivery capabilities based on the problem, environment, and business outcome.

V&V

Software Validation & Verification

End-to-end CSV/CSA consulting for Class I, II and III medical-device manufacturing and other regulated computerized systems.

  • New systems, ERP processes, labeling and 3D scanner validation
  • Validation remediation and maintaining the validated state
  • Independent Verification & Validation (IV&V)
  • GAMP 5, 2nd Edition aligned risk-based approach
ERP

ERP Implementation & Transformation

Hands-on leadership for new ERP implementations, major upgrades, enhancements, recovery, and enterprise change.

  • End-to-end implementation leadership
  • Requirements, testing, migration and cutover
  • ERP upgrade & enhancement project management
  • Dynamics 365 Business Central, SAP and Anaplan experience
SAP

SAP Operational Support & Stabilization

Senior consulting for complex SAP environments requiring stability, structured support, problem resolution, and controlled change.

  • SAP ECC, EPM/BPC and Fiori experience
  • Operational stabilization and production support
  • Enhancements, testing, cutovers and upgrades
  • Knowledge transfer and continuous improvement
PM

Project & Program Management

Leadership for complex enterprise initiatives that require clear governance, execution discipline, stakeholder alignment, and delivery focus.

  • ERP and enterprise application programs
  • Cross-functional and global delivery
  • Risk, issue, dependency and vendor coordination
  • Executive-level communication and decision support

Troubled Project & Program Recovery

Recovery leadership for initiatives that are behind schedule, poorly organized, unstable, or not delivering expected outcomes.

  • Rapid assessment and recovery planning
  • Governance and priority reset
  • Team rebuilding where needed
  • Execution through stabilization and delivery
DB

Data Migration, Reconciliation & Validation

Structured data-conversion consulting for ERP implementations, system replacements, carve-outs, integrations, and major upgrades.

  • Extraction, mapping, cleansing and transformation
  • Migration planning and execution
  • Record-count, balance and exception reconciliation
  • Post-migration completeness and accuracy verification

Complex Systems Integration & PunchOut

Consulting for complex integrations between ERP platforms, suppliers, procurement systems, financial platforms, and external applications.

  • PunchOut and eProcurement processes
  • Business and technical requirements
  • Integration testing and troubleshooting
  • Vendor and cross-system coordination
M&A

Business Carve-Outs & M&A Technology Integration

Technology and business-process leadership for business separation, consolidation, acquisition, and enterprise restructuring.

  • ERP and application separation or consolidation
  • Data, integrations and process dependencies
  • Testing, cutover and continuity planning
  • Cross-functional business and technology coordination
GO

Cutover, Go-Live & Operational Readiness

Structured leadership for high-risk launches and major system changes where execution, timing, dependencies, and continuity matter.

  • Cutover planning and runbooks
  • Readiness and go/no-go criteria
  • Migration, integration and testing dependencies
  • Business continuity and contingency planning
TEST

Testing & Test Management

Independent test leadership for ERP, integration, migration, and enterprise-system initiatives in regulated and non-regulated environments.

  • Test strategy and test-script development
  • Integration testing and UAT
  • Defect management and regression testing
  • AI-assisted test preparation with HITL controls
BP

Business Process Documentation & Lean Improvement

Document, understand, simplify, and improve business processes using Lean thinking and practical technology enablement.

  • Current-state and future-state process mapping
  • Roles, handoffs, controls and gaps
  • Waste, bottleneck and rework reduction
  • Automation opportunities and process redesign
REQ

Requirements Development & Management

Translate business needs into structured, actionable requirements that can drive implementation, configuration, development, and testing.

  • Requirements elicitation and documentation
  • Acceptance criteria and prioritization
  • Business-process alignment
  • Requirements change management
AI

AI Adoption, Governance & Human-in-the-Loop

Help organizations introduce AI into business and technology processes with practical governance, procedures, and human accountability.

  • AI-enabled process design
  • Human-in-the-Loop review and approval controls
  • Processes, procedures and governance
  • Lean + AI workflow acceleration
WI

Training, Knowledge Transfer & Work Instructions

Convert tribal knowledge into repeatable institutional knowledge that can be trained, supported, and sustained.

  • SME knowledge capture
  • Work instructions and training materials
  • ERP and business-process training
  • Team onboarding and knowledge transition
SOP

SOP, Procedure & Work Instruction Development

Create professional operational documentation for repeatable business, technology, validation, and quality-support processes.

  • SOP and procedure development
  • Detailed work instructions
  • Process-flow documentation
  • AI-assisted drafting with human review
APP

Quality-System & Business-Process Applications

Design and develop focused internal tools that support defined quality-system or business-process needs.

  • Inspection and quality-support tools
  • Controlled workflow applications
  • Data-capture and process-support tools
  • Validation-support applications
DATA

Data & Reporting Improvement

Improve the reliability of financial and operational information by addressing data, reconciliation, reporting, and process issues.

  • Reporting accuracy and consistency
  • Data quality and reconciliation
  • Spreadsheet-heavy process improvement
  • Financial and operational reporting support
FIN

Financial Systems Consulting

Consulting across budgeting, planning, reporting, financial platforms, and enterprise financial-system modernization.

  • SAP EPM/BPC and Anaplan experience
  • Budgeting and planning processes
  • Financial data and reporting
  • System stabilization and modernization
INT

Fractional & Interim Technology Leadership

Temporary senior leadership for organizations that need experienced technology, ERP, validation, or program leadership without a permanent hire.

  • Fractional / interim IT leadership
  • ERP and enterprise application leadership
  • Validation / CSV / CSA leadership
  • Team rebuilding and organizational recovery
Software Validation & Verification

End-to-end validation consulting with practical, risk-based execution

Sudita can lead a full validation engagement for regulated computerized systems or apply the required validation disciplines within a broader consulting engagement. The approach combines experienced professional judgment, Lean methods, AI-assisted document acceleration, and Human-in-the-Loop review and approval.

Medical-device validation experience

Support for Class I, II and III medical-device manufacturing environments, including ERP processes, labeling systems, 3D scanners, new computerized systems, inspection/quality tools, migrations, integrations, and major system changes.

Risk-based delivery can be aligned with applicable quality-system requirements and recognized industry guidance, including GAMP 5, 2nd Edition.

CSV / CSA GAMP 5, 2nd Ed. ISO 13485 21 CFR Part 11 Class I / II / III Human-in-the-Loop
Validation PlanOverall scope, governance, risk-based approach, deliverables, responsibilities and completion criteria.
Software Validation ProtocolExecution framework, testing rules, acceptance criteria, deviation handling and validation controls.
Requirements Traceability Matrix (RTM)Trace requirements through risk, testing, execution results and final disposition.
Business Process CatalogDocument validated business processes, ownership, systems, controls and supporting requirements.
Master Test StrategyDefine the overall testing approach, environments, responsibilities, evidence, defect handling and coverage.
Test Script DevelopmentDevelop risk-based test scripts, including Data Migration Validation Tests and process-specific validation tests.
Test ExecutionExecute or manage controlled validation testing with objective evidence and documented results.
RTM MaintenanceMaintain traceability as requirements, tests, results, deviations and dispositions evolve.
Remediation & RetestingManage deviations, corrections, targeted retesting, regression decisions and final disposition.
Individual Test SummariesSummarize execution, failures, remediation, evidence and final test conclusions.
Validation Summary ReportProvide the final validation conclusion, completion evidence, deviations, traceability status and release recommendation.
Validation Remediation & Maintaining Validated StateRecover incomplete or outdated validation and support ongoing review after system changes, upgrades and enhancements.
Independent Verification & Validation (IV&V)Provide independent evaluation of requirements, testing, traceability, evidence and validation completeness.
Lean + AI + Human Review

Use AI to accelerate the work—not replace professional judgment

Sudita uses controlled AI automation and Lean methods to reduce manual document effort and improve consistency while retaining Human-in-the-Loop review, approval, accountability, and decision-making.

How Sudita works

AI can accelerate drafting, traceability preparation, test documentation, work instructions, process documentation, requirements organization, and other structured consulting activities. Human review remains responsible for correctness, context, risk decisions, and final approval.

AI adoption consulting for clients

  • Identify appropriate AI-enabled workflows
  • Define Human-in-the-Loop controls and approval points
  • Create processes, procedures and governance
  • Apply Lean methods before automating inefficient work
  • Build repeatable quality and accountability into AI-assisted processes
Industry Experience

Experience across regulated, industrial, enterprise, and service environments

Sudita brings cross-industry perspective to technology, validation, ERP, data, integration, process, and project challenges.

Medical Devices
Higher Education
Oil & Gas
Infrastructure
Consumer Electronics
Third-Party Logistics (3PL)
Construction Equipment Manufacturing
Enterprise Financial Systems
How Sudita Works

Executive perspective with hands-on delivery

Sudita combines strategic leadership with practical execution. The focus is to understand the business problem, organize the work, reduce unnecessary complexity, establish control, and drive the initiative toward a measurable outcome.

From instability to controlled execution

Complex initiatives often fail because ownership, requirements, dependencies, testing, documentation, data, or decision-making are fragmented. Sudita brings structure to the environment and focuses the team on the highest-value work.

UnderstandClarify the business outcome, systems, processes, dependencies, risk and stakeholders.
StabilizeResolve the highest-impact operational, project, data, process or governance problems.
ExecuteEstablish requirements, plans, testing, controls, ownership and measurable delivery.
SustainTransfer knowledge, document critical processes, strengthen the team and leave the operation more resilient.

Enterprise platforms and complex change

Experience includes SAP, Anaplan, Dynamics 365 Business Central, financial systems, regulated validation, complex integrations, data migrations, carve-outs, business separations, M&A integration, enterprise testing, and global technology programs.

ERP & ApplicationsImplementation, operational support, stabilization, upgrades, enhancements and recovery.
Validation & TestingRisk-based validation, IV&V, test strategy, test management, remediation and maintaining validated state.
Data & IntegrationMigration, reconciliation, PunchOut, enterprise integrations and complex system dependencies.
People & ProcessTeam rebuilding, tribal-knowledge capture, work instructions, Lean improvement and AI-enabled workflows.
Selected Results

Experience demonstrated through outcomes

Representative results from enterprise application leadership, consulting, operational recovery, training, validation, and continuous improvement work.

24%

Fewer recurring incidents

Lean, ITIL, Pareto analysis and root-cause elimination improved operational reliability and reduced support demand.

5 mo.

Financial systems organization rebuilt

Re-established team capability, governance, documentation, support and institutional knowledge in a mission-critical environment.

400+

SAP users trained

Enterprise-scale user enablement supporting warehouse operations and global SAP initiatives.

Global

Cross-border program leadership

Coordinated enterprise teams and programs spanning multiple countries and business functions.

FDA

Regulated validation leadership

Led validation work for regulated manufacturing technology, including structured protocols, testing, traceability and final validation evidence.

AI + HITL

Faster structured documentation

Applied Human-in-the-Loop AI methods to requirements, testing, validation, process documentation and operational workflows.

Need experienced help with a complex technology or validation initiative?

Whether the challenge is software validation, ERP implementation, SAP operations, data migration, testing, a business carve-out, project recovery, AI adoption, process improvement, or temporary senior leadership, let’s discuss the outcome you need.