Services

Computer System Validation

Forza Pharma Consulting delivers full-scope Computer System Validation (CSV) services to ensure that GxP-regulated software and automated systems meet compliance and performance standards. We help clients achieve FDA 21 CFR Part 11 and EU Annex 11 compliance while optimizing data integrity and business continuity.

Areas of Expertise

• Risk-based validation planning for on-premises and SaaS applications
• Electronic records/electronic signatures compliance (ER/ES)
• IT change management
• Release management
• Data integrity assessments and remediation
• Business continuity planning, incident management, and disaster recovery

Systems We Support

• Quality management systems (QMS)
• Document management systems (EDMS)
• Training / learning management systems (LMS)
• Validation lifecycle management systems (VLMS)
• Content management systems (CMS)
• Analytical software platforms
• Laboratory information management systems (LIMS)
• Manufacturing execution systems (MES)
• Enterprise resource planning (ERP) platforms
• DCS, PLC, SCADA automation systems
• Single sign-on (SSO) integrations

Partner with Forza Pharma Consulting to ensure your critical computer systems meet global compliance standards.