Computer System Validation

Computer Systems Validation, Testing, And Compliance Services

If you are seeking computer system validation experts, look no further. Delta Enviro Solutions has demonstrated expertise validating computer programs for all types of regulated businesses in the energy, transportation, financial services, and life sciences (including FDA-regulated businesses such as pharmaceutical and medical device manufacturers, clinical research organizations, and GLP laboratories).

Our Systems and Equipment Validation Processes Encompass the Entire Gamut of Business Operating Systems.

  • Upgradation of Legacy Systems
  • Automation Support
  • PLC and SCADA Validation as per GAMP Requirements
  • Application Software Validation as per GAMP and EU ANX 11 and 21 CFR Part 11
  • EMS/BMS Qualification
  • Audit Trail Review Assessments
  • Periodic Review Assessments
  • ERES Assessments
  • GAP Assessments for All types Computerized Systems
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Our Process

Delta Enviro Solutions experts have a thorough understanding of federal regulations and industry-accepted software development standards. Our clientele is comprised of industries regulated by the FDA, FCC, IRS, and SEC. We utilize a five-step process for all computer system validation projects:

Draft and Approve SLC Documentation

Execute Test Protocol & Validation Scripts

Review & Approve

Closeout, Summary Report & Document

  • Project Management
  • Software Development Life Cycle
  • Gap Assessments
  • Risk Assessments
  • Validation Master Planning (VMP)
  • User Requirements Specifications (URS)
  • Functional Specifications (FS)
  • Design Specifications (DS)
  • Design Review
  • Data Archiving
  • Continuity Planning
  • Change and Configuration Management
  • Incident and Problem Management
  • Periodic System Reviews
  • Best Practices
  • Leveraging of Vendor Documentation
  • Unit Testing
  • Integration Testing
  • System Testing
  • Site Acceptance Testing (SAT)
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)
  • Requirements Traceability