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Computer System Validation & Clean Room Validation

FDA 21 CFR Part 11 Compliant

RAPS Affairs Solutions delivers regulatory-grade validation services for Pharmaceuticals, Bio Sciences, Medical Devices, Semiconductor, FMCG, and Food industries—ensuring data integrity, system reliability, and inspection readiness.

Talk to Our Validation Experts

Computer System Validation & Clean Room Validation

Computer System Validation (CSV) Services

FDA 21 CFR Part 11 | GAMP 5 | EU GMP Annex 11

RAPS Affairs Solutions provides end-to-end Computer System Validation (CSV) services for regulated industries to ensure computerized systems are fit for intended use, compliant, and audit-ready.

Systems We Validate

  • ERP, MES, QMS, LIMS
  • SCADA, PLC & Automation Systems 
  • Laboratory Instruments & Software 
  • Environmental Monitoring Systems (EMS) 
  • Cloud-based & AI-enabled platforms

Our CSV Lifecycle

  • Validation Master Plan (VMP) 
  • System Risk Assessment & Classification 
  • User Requirements Specification (URS) 
  • Functional & Design Specifications (FS/DS) 
  • Installation Qualification (IQ) 
  • Operational Qualification (OQ) 
  • Performance Qualification (PQ) 
  • Periodic Review & Change Control

21 CFR Part 11 Coverage

  • Electronic records & electronic signatures 
  • Secure user access and role-based controls 
  • Audit trail implementation & review 
  • Data backup, retention & recovery 
  • ALCOA++ data integrity compliance

Clean Room Area Equipment Validation

GMP | ISO 14644 | FDA 21 CFR Part 11

 We offer comprehensive clean room qualification and validation services to ensure environmental control, sterility, and regulatory compliance across controlled manufacturing environments. 

Equipment Covered

  • HVAC & Building Management Systems (BMS) 
  • Environmental Monitoring Systems (EMS) 
  • Temperature, Humidity & Differential Pressure Systems 
  • Particle Counters 
  • Laminar Air Flow (LAF) & Biosafety Cabinets 
  • Clean Room Software & Data Loggers

Qualification Approach

  • Design Qualification (DQ) 
  • Installation Qualification (IQ) 
  • Operational Qualification (OQ) 
  • Performance Qualification (PQ)

Part 11 Compliance for Clean Rooms

  • Secure access controls 
  • Audit trails for GMP data 
  • Time-stamped electronic records 
  • Data integrity & backup verification

Industries We Serve

Pharmaceuticals & Bio Sciences

  • GMP manufacturing & QC systems 
  • Sterile & non-sterile environments 
  • FDA and global regulatory compliance

Bio Labs & Research Facilities

  • LIMS validation 
  • Data integrity & audit trails

Medical Devices

  • ISO 13485 aligned CSV 
  • SaMD & automated systems 
  • FDA inspection readiness

Semiconductor Industry

  • Clean room automation systems 
  • Environmental & process control validation

FMCG Industry

  • Quality and monitoring systems
  • Data integrity for automated processes

Food Industry

  • Environmental & safety monitoring 
  • Computerized system compliance

Frequently Asked Questions

Please reach us at info@rapsaffairs.com if you cannot find an answer to your question.

Any computerized system impacting product quality, patient safety, or data integrity must be validated. 

 Yes, if the system generates, stores, or manages electronic GMP data. 

 Yes. We follow a GAMP 5 risk-based approach for modern technologies. 

 Yes. We conduct gap assessments and support remediation and re-validation. 

FDA 21 CFR Part 11, GAMP 5, EU GMP Annex 11, ISO 14644, ISO 13485, WHO GMP, and ALCOA+. 

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