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Computer System Validation (CSV/CSA/PLC)

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About Us

In GxP-regulated industries, computerized and automated systems are at the core of quality, compliance and patient safety. We deliver comprehensive lifecycle validation services across all GxP-relevant systems, spanning manufacturing, quality, engineering, laboratories, IT and business operations. Our approach covers standalone, networked, automated and enterprise systems from planning through retirement with regulatory expertise, engineering understanding and practical execution, ensuring compliance without unnecessary burden. Validation is performed using a structured, risk-based lifecycle methodology aligned with global regulatory expectations.

What We Do for You

Computer System Validation (CSV)

End-to-end lifecycle validation of GxP computerized systems aligned with GAMP® 5 and global regulatory expectations.

PLC & Automation System Validation

Validation of PLC, SCADA, and automated control systems ensuring process reliability, data integrity, and compliance

Computer Software Assurance (CSA)

Risk-based assurance approach focusing on critical thinking, patient safety, and elimination of overvalidation.

Gap Assessment

Structured evaluation of existing systems and documentation against regulatory and data integrity requirements

Risk Assessment

GxP impact and functional risk assessment using a defensible, documented methodology to define validation scope and testing depth

Computer System Validation (CSV)

We provide end-to-end validation of all GxP-relevant computerized systems, regardless of platform, deployment model, or complexity.

  • ERP, LIMS, QMS, DMS, TMS, BMS, MES, etc.
  • Custom-built and configurable software
  • On-premise, cloud, hybrid and SaaS systems
  • Systems used across QA, QC, Manufacturing, Engineering, IT, R&D, HR, Supply Chain, Regulatory and Management

CSV Scope Includes:

  • Validation Master Plan (VMP)
  • System Impact & GxP Assessment
  • Risk Assessment & Intended Use Definition
  • URS, FS, DS & Traceability Matrix
  • IQ, OQ, PQ Execution
  • Data Integrity & Part 11 Compliance
  • Change Management & Periodic Review

PLC & Automation System Validation

We provide validation for automation and control systems used in regulated manufacturing and utility environments.

  • PLC, SCADA, DCS, BMS systems
  • Manufacturing equipment and utilities
  • IO verification & functional testing
  • Alarm, interlock, and fail-safe verification

Integration with MES, ERP and quality systems. Our validation ensures process reliability, compliance and data integrity in automated environments.

Computer Software Assurance (CSA)

Aligned with the latest FDA CSA guidance, our CSA services focus on critical thinking and risk-based assurance, rather than excessive documentation.
  • Criticality and risk-based system assessment
  • Reduced testing for non-critical functions
  • Assurance activities focused on patient and product impact
  • SaaS and cloud-friendly validation models
  • Efficient, compliant documentation suitable for inspections

Gap Assessment

We conduct structured Gap Assessments to evaluate existing systems, documentation, and validation practices against
current regulatory expectations.

Assessment Areas:

  • Compliance review (21 CFR Part 11, EU Annex 11)
  • Data Integrity (ALCOA+) assessment
  • Documentation and lifecycle gap analysis
  • Remediation roadmap and action plan.

Why Choose Cleanstep?

 Trusted expertise | Proven methodology | Regulatory confidence | Reliable delivery.

  • Risk-Based Validation Approach
  • End-to-End CSV Lifecycle Support
  • Regulatory, Technical Expertise & Audit-Ready Documentation,

Need to Validate Your Computerized Systems?

Partner with Cleanstep Pharma and Engineering Solutions. for reliable, risk-based, and regulatory-compliant Computer System Validation (CSV) services. Our experienced validation professionals help ensure your computerized systems meet GAMP® 5, 21 CFR Part 11, EU GMP Annex 11, and GxP requirements through comprehensive validation, audit-ready documentation, and efficient project execution.

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