Computer System Validation (CSV/CSA)
Computerized system validation (CSV) (Computerised system validation in European countries, and usually referred to as "Computer Systems Validation") is the process of testing/validating/qualifying a regulated (e.g., US FDA 21 CFR Part 11[1]) computerized system to ensure that it does exactly what it is designed to do in a consistent and reproducible manner that is as safe, secure and reliable as paper-based records. This is widely used in the Pharmaceutical, Life Sciences and BioTech industries and is a cousin of Software Testing but with a more formal and documented approach. The validation process begins with validation planning, system requirements definition, testing and verification activities, and validation reporting. The system lifecycle then enters the operational phase and continues until system retirement and retention of system data based on regulatory rules.
Similarly, The Rules Governing Medicinal Products in the European Union, Volume 4, Annex 11: Computerised Systems applies to all forms of computerized systems used as part of a GMP regulated activities and defines Computer System Validation Elements [2]
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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
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Computer System Validation Training
Ofni Systems has given computer validation presentations and training classes to organizations like FOI Services, ISPE, IVT, and PDA.
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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.
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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.