Software has become an integral and essential component of many medical products. Whether used to control the diagnostic functions of a sophisticated medical device or to manage a complex manufacturing process, software plays a vital role in today’s development and delivery of medical science.

This heavy reliance on software brings with it unique regulatory requirements and challenges. Beaufort Advisors can help you understand the requirements related to software and work with you to ensure that your systems are validated in accordance with applicable regulations and standards.

Software Validation Services
»	21 CFR Part 11 compliance
»	Technology audits, risk assessments and gap analyses
»	IT strategy development and review
»	System validation master planning
»	Definition of system design requirements and specifications (user and functional)
»	Development of system-specific, process-level standard operating procedures
»	Development of software and documentation change control processes and procedures
»	Development of traceability processes and matrices
»	Development of software validation and verification plans and test protocols
»	Validation and verification test execution
»	Data analysis and generation of validation reports
»	Development of remediation plans
»	Software quality audits and design control audits
»	Commercial software and vendor qualification audits
»	Software integration and data migration
»	IQ/OQ/PQ of equipment and system components
»	Software validation and verification training

To discuss how Beaufort Advisors can help you achieve your regulatory compliance objectives, please contact us at info@beaufortadvisors.com or call 757.383.6000 .