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

Develop comprehensive validation plans and protocols in order to describe the nature, objectives, and testing demands of a given computerized system.

Risk-Based Validation Approach

Performing risk assessments on your computerized systems to evaluate their criticality, and a risk-based strategy where validation efforts are focused in high-risk areas.

System Installation Qualification (IQ)

Ensuring that your computerized systems are correctly installed and fulfill all required specifications: a good basis for operational functionality.

Operational Qualification (OQ)

Test to see if your systems can function as required under all anticipated operational conditions.

Performance Qualification (PQ)

Conduct performance qualification to confirm that your systems consistently achieve results meeting predetermined criteria in actual usage situations.

Data Integrity and Security Validation

To see that your systems maintain data integrity and security in compliance with FDA 21 CFR Part 11

Change Control and Revalidation

Operationally speaking, monitoring system changes and upgrading through implementation of change control procedures: all changes must be validated in compliance with regulatory criteria.

CSV Documentation and Reporting

All validation activities are subject to comprehensive documentation, including validation protocols, test scripts, summary reports, and traceability matrices to demonstrate compliance.

BioBoston Consulting’s CSV Services: keeping your systems compliant

Our Computer System Validation (CSV) services offer the expertise and support that life sciences companies need in order to ensure their computerized systems are compliant, secure and reliable. Let us help you validate systems under regulatory requirements and maintain data integrity.

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.