The FDA and other regulatory agencies have established criteria for software-based applications developed for use within the pharmaceutical, biological, and medical device industries. Focus personnel have experience with computer systems validation activities and provide services for a full range of validation deliverables, from Validation Plans through Validation Summary Reports.


Focus delivers services and tools to help clients integrate good software-based engineering practices into their product-development methodologies for the purpose of FDA regulatory compliance. These services include:

  • User Requirement Specification
  • Functional Detailed Descriptions
  • Risk Assessment
  • Traceability Analysis
  • CSV Master Planning
  • Configuration/Change Management
  • Software Validation and Software Development Life Cycle
  • Part 11: E-records and E-signatures

These services are available for a number of applications, including:

  • Automated Processes
  • Network/IT Infrastructure
  • Software Imbedded Devices
  • Computerized Systems
  • Database systems
  • Enterprise Resource Planning systems
  • Laboratory Information Management systems