Computer Systems Validation
Ensure that your technology systems and processes are compliant
From CFR Part 11 to HIPAA requirements and more, validation of computer systems, software and processes is essential for life sciences companies. Do you have SOPs in place for password protection? Are potential vendors compliant with your requirements? Do you have a plan for data migration?
Third-party IT vendors can provide validation packages with their systems, but they lack compliance necessary to satisfy regulatory authorities. Safis Solutions, on the other hand, specializes in compliance – including compliance issues related to hardware, software, and IT systems. Our talented on-staff technology experts can help you know which questions to ask – and what the answers should be.
Our Computer Systems Validation Services
Our computer system validation services include validation master plans, testing services, SDLC and technical documentation. In particular, Safis Solutions specializes in the validation of software that is integrated with devices, instrumentation or diagnostics.
Specific areas of expertise include:
- IT quality system design and implementation
- IT validation SOP templates
- Assistance with vendor selection and auditing of computer systems
Learn about our other types of auditing services »
- Requirements gathering and development
- Design and development of systems
Learn about our quality systems service »
- Data migration
- Software testing and verification
- System documentation
- IT quality SOPs