Computer System Validation

For Life Science companies, computerized systems are crucial to data control, process automation, and regulatory compliance. Computer-system validation (CSV) is needed to ensure that these programs run as intended in full adherence with industry guidelines. At BioBoston Consulting, we provide comprehensive CSV services to help companies validate their computerized systems, ensuring data integrity, system security, and regulatory compliance.

Why Choose BioBoston Consulting for Computer System Validation (CSV)?

Expertise of CSV Regulations and Best Practices

Our team has in-depth knowledge of the life sciences industry regulatory layout, including FDA 21 CFR Part 11, EMA, and GAMP 5 guidelines. We help you implement CSV procedures that bring your computerized systems into full compliance with all necessary regulatory requirements while meeting the highest standards for data integrity, reliability, safety and security.

End-to-End CSV Support

From planning stage through to final validation, we cover your entire CSV needs. Our service embraces everything from developing validation plans to verifying the functionality of system, during which time we will make sure that your electronic systems work dependably and securely.

Customized CSV strategies

We understand that every system and organization is unique. Our CSV services are tailored to your company’s particular needs, ensuring that your computerized systems are validated in accordance with their complexity, business criticality and regulatory impact.

Compliance and Risk Control

Our CSV services guarantee that your systems conform to FDA, EMA and other global regulatory authorities, helping you avoid very expensive compliance issues. We conduct risk assessments to identify potential vulnerabilities and make sure that your system is secure and compliant.

Detailed Documentation:

We provide detailed documentation as part of the CSV process, ensuring that you have a complete audit trail of validation activities. This documentation supports regulatory inspections and demonstrates compliance with industry standards.

Our Computer System Validation (CSV) Services Include:

• CSV Planning and Protocol Development
• Risk-Based Validation Approach
• System Installation Qualification (IQ)
• Operational Qualification (OQ)
• Performance Qualification (PQ)
• Data Integrity and Security Validation
• Change Control and Revalidation
• CSV Documentation and Reporting
• BioBoston Consulting’s CSV Services: keeping your systems compliant

Contact Our Team

Schedule a consultation to learn how BioBoston Consulting can support your computer system validation needs and ensure the compliance and integrity of your electronic systems.