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.
Services
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