Software Qualification

Computer systems validation has evolved greatly over the last two decades. In light of the FDA's new "GMPs for the 21st Century Initiative", it is of great importance to provide an efficient, systematic approach to computer system validation. ASI's Computer Systems Validation (CSV) methodology strives to achieve the Three R's; Reliability, Robustness and Repeatability for any application ASI validates. ASI's System Development Life Cycle Methodology (SDLC) is based on GAMP5 and ISO standards.

ASI has hands-on experience with validation of the following computerized systems:

  • Process Control Systems
  • Maintenance Management Systems
  • Data Historians
  • Calibration Management Systems
  • Manufacturing Execution Systems
  • Real Time Performance Management Systems
  • SCADA Systems
  • Databases
  • Quality Management Systems
  • Laboratory Information Management Systems
  • CAPA Management Systems
  • Building Management Systems
  • Document Management Systems
  • Environmental Monitoring Systems
  • Complaint Management Systems
 

 

Computer/Software Validation Expertise

  • Software Purchasing Controls
  • Software Design & Coding Standards
  • Software Quality Planning
  • Risk Assessment
  • Vendor Assessment/Supplier Audit
  • Establishment of Requirements
  • User Requirements Specification
  • Functional Specification
  • Detailed Design Documents
  • Configuration Specification
  • System Development Testing
  • Integration Testing
  • Factory Acceptance Test
  • Site Acceptance Test
  • System HIQ/SIQ
  • System SOQ
  • System PQ
  • Traceability Matrix
  • Summary Report
  • Software Design & Review
  • Software Document Control & Review
  • Software Change Management
  • Software Resource Management