Computer System Validation (CSV)

Computer system validation (sometimes called computer validation or CSV) is the process of documenting that a computer system meets a set of defined system requirements. Validation of computer systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records is a critical requirement of electronic record compliance, as described in the FDA 21 CFR 11.10(a) and EMA Annex 11, Section 4.

Computer System Validation Services

Our computer system validation experts have validated computer programs for all types of FDA-regulated businesses, including pharmaceutical and biologics manufacturers, medical device manufacturers, clinical research organizations, and GLP laboratories.

• Software Validation – Computer systems validation services for SAP, LIMS, Salesforce, Trackwise, and other business and laboratory data management systems
• Web Based Applications – Specialized validation services for web, cloud, and mobile applications
• MS Excel Spreadsheets – Spreadsheet security and compliance with 21 CFR 11
• MS Access Databases – Your internally-created databases made compliant with FDA requirements

Computer System Validation Training

Ofni Systems has given computer validation presentations and training classes to organizations like FOI Services, ISPE, IVT, and PDA.

• Computer System Validation – Scalable training classes on computer validation. Learn computer system validation principles and ensure compliance.
• Spreadsheet Compliance and Validation – Online training classes that discuss specific validation requirements for spreadsheet validation
• Review of Computer System Validation Documentation and Techniques – Web-based classes that provide an overview of the validation process and best practices

Computer System Validation Resources

Additional computer system validation guidance and resources from Ofni Systems

• Validation Documents – A library of information about computer system validation plans, functional specifications, and other validation documentation
• 21 CFR 11.10(a) – Read about FDA computer system validation requirements with additional commentary from Ofni Systems validation experts.
• FastVal – Control your validation process with Ofni Systems validation management system.

Additional Electronic Record Compliance Services

• Part 11 and Validation Assessments – Ofni Systems can review your electronic record compliance or create audit checklists for your organization.
• Software Testing – Stress testing, challenge testing, load testing, and other specialized software testing services for FDA-regulated businesses
• Data Migration – Migrate data from legacy systems and ensure accurate data transfer following FDA guidelines.

Maximize the Benefits of Computer System Validation

Computer validation is more than a compliance requirement. Pharmaceutical computer system validation is a unique opportunity for a business to examine their computer systems to maximize effectiveness and enhance quality. Ofni Systems ensures that your validation project clearly documents why your customers should share the high degree of confidence you hold in your company and your systems, while scaling the project to your organizational validation requirements and budget.