Validation & Qualification Computer System Validation (CSV) Services

Ensure your computerized systems maintain data integrity and operational reliability through risk-based validation that satisfies 21 CFR Part 11 while enabling technological advancement.

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Digital compliance in an increasingly automated life science environment

Computerized systems control everything from research data to production equipment, from quality decisions to product distribution. Their failure can compromise product quality, data integrity, and regulatory compliance. Yet traditional validation approaches—developed for simpler systems—often create documentation burdens that inhibit innovation and agility.

Modern CSV requires sophisticated strategies. Risk-based approaches that focus on critical functions. Lifecycle methodologies that maintain compliance through changes. Practical solutions that balance regulatory requirements with business needs. Most importantly, validation that enables rather than constrains your digital transformation.

Our CSV specialists combine IT expertise with regulatory knowledge. We've validated systems from simple spreadsheets to complex enterprise platforms, always focusing on demonstrating control while maintaining flexibility.

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Our CSV services include:

  • CSV master planning and strategy
  • 21 CFR Part 11 assessment and remediation
  • Risk assessment and criticality determination
  • User requirements and functional specifications
  • Design qualification documentation
  • Installation and operational qualification
  • Performance qualification and user acceptance
  • Data migration validation
  • Interface and integration testing
  • Security and access control validation
  • Disaster recovery and backup validation
  • Change control and lifecycle management
  • Validation maintenance programs

System types we validate include but are not limited to:

  • Laboratory Information Management Systems (LIMS)
  • Enterprise Resource Planning (ERP)
  • Manufacturing Execution Systems (MES)
  • Electronic Batch Records (EBR)
  • Quality Management Systems (QMS)
  • Document Management Systems
  • Clinical Data Management Systems
  • Spreadsheets and databases
  • Equipment software and firmware
  • Cloud and SaaS applications

Click to expand How we validate computerized systems

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We approach CSV as a disciplined lifecycle—from planning to operation to change control. Our services fall into three core phases: Planning & Strategy, Qualification & Execution, and Lifecycle & Change Control.

  • Strategy & Planning

    • CSV Master Plan / Strategy: Define scope, roles, risk tiers, vendor expectations, and validation approach (GxP vs. non-GxP).

    • Part 11 & Data Integrity Assessment: Assess compliance with 21 CFR Part 11, ALCOA+ principles, audit trails, and electronic signature needs.

    • Risk Assessment & Criticality Scoping: Prioritize system functions by risk, defining what needs full validation vs. lighter controls.

    • User Requirements & Functional Specifications (URS / FRS): Clarify how the system must perform and interface with other systems.

    • Architecture, Interface & Integration Planning: Document system modules, data flows, external interfaces, and security dependencies.

  • Qualification & Execution

    • Design / Design Qualification (DQ): Ensure design aligns with requirements and risk assessments.

    • Installation Qualification (IQ) / Configuration Checks: Confirm system installation, hardware/firmware, folder structure, environment requirements, and dependencies.

    • Operational Qualification (OQ) / Functional Testing: Validate functions, error handling, boundary conditions, validations, security, and workflows.

    • Performance Qualification (PQ) / User Acceptance Testing (UAT): Confirm system meets requirements in production-like scenarios, with representative users.

    • Interface / Integration Testing: Validate data exchange, API calls, messaging, error conditions, and data integrity across interfacing systems.

    • Data Migration / Conversion Validation: Validate that legacy data moved into the new system retained accuracy, integrity, and traceability.

    • Security & Access Control Validation: Verify user roles, privileges, password rules, segregation of duties, audit trail settings.

    • Backup, Recovery & Disaster Recovery Checks: Test system recovery paths, backups, restore procedures, resilience to system failures.

  • Lifecycle Support & Change Control

    • Change Control & Revalidation Triggers: Define criteria (software updates, upgrades, configuration changes) that require requalification or regression testing.

    • Validation Maintenance & Periodic Review: Refresh risk assessments, review audit trails, monitor system performance, and verify ongoing compliance.

    • Vendor Management & Qualification Oversight: Assess third-party software or cloud vendors for their validation practices, compliance posture, and service-level agreements.

    • Defect / Deviation Handling & Remediation: Procedures for logging, investigating, and resolving validation deviations or software defects.

    • Audit Readiness & Documentation Support: Maintain traceability matrices, mapping, validation reports, change logs, and other required artifacts to support regulatory inspections.

    • Training & Handover: Provide system users and support teams with validated training materials and operational procedures.

  • System Types & Environments We Validate

    • LIMS (Laboratory Information Management Systems)

    • ERP / MES / EBR / QMS / Document Management Systems

    • Clinical Data Management Systems

    • Equipment software and firmware

    • Spreadsheets, databases, and analytics platforms

    • Cloud-based / SaaS / hosted systems

     


     

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The FDA Group's CSV advantage

  • Technical depth: Understand both systems and regulations
  • Risk-based focus: Validate what matters most
  • Practical approach: Documentation that's useful, not just compliant
  • Modern methods: Leverage GAMP 5 and current best practices
  • Lifecycle support: Maintain validation through changes

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Why work with The FDA Group?

 
  • Exclusive life science focus and expertise
  • Dedicated account management team
  • Right resource, first time (95% success)
  • 97% client satisfaction
  • Total Quality Guarantee

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Our Proven Process

Introductory Conversation

  • About Us
  • About You
  • Scope Of Work

Resources Definition

  • Background And Expertise
  • Location Of Resource
  • Rate Rightsizing

Proprietary Resource Selection Process

  • In-House Subject Matter Experts
  • Recruiting Team External Search
  • Resource Identification

Resource Presentation

  • CV And Rate
  • Perfect Match Summary
  • Interview Call Coordination

Agreement Processing

  • MSA And Addendums
  • Supplier Qualification
  • Kickoff Coordination

Account Management

  • Project Management Of Resource
  • Satisfaction Management of Client
  • Total Quality Guarantee

Contact us and get the conversation started.

Our resources can be utilized to meet the wide range of remediation requirements throughout the life sciences, as well as to support staffing assignments, lead and manage related activities, bridge staffing gaps, and provide long-term or interim leadership.

Please contact us to learn more about fulfilling specific validation needs. We help clients secure a wide variety of life science resources for both contracted and direct hire engagements with the perfect combination of qualifications, experience, and motivation for succeeding in challenging and demanding projects.