Computer System Validation for a new system implementation or upgrade from an existing system to a new system requires substantial time, money, and effort. We offer a deep understanding of the underlying software, allowing us to define the scope of the validation effort accurately, ensuring efficiencies on all three counts. Our proven methodology utilizes standard validation package and ensures that the validation plan developed is comprehensive and effective in ensuring the system performs as intended and meets regulatory requirements.
Our Computer System Validation (CSV) consulting services include:
- Regulatory Compliance with authorities such as EMEA, FDA and PMDA
- 21 CFR part 11 and EU Annex 11 compliance for Software/Systems
- Standard Validation package for Safety System
- Validation strategy based on the Regulatory Guidance for:
- New Safety System implementation
- Upgrade to existing Safety System
- Data Migration
- BI Tools and Custom Reports
- Automated Regression test bed for ongoing upgrades for cloud hosted safety systems
- Implementation of CSA, risk-based approach from FDA for Validation
- Validation approach for regulatory requirements including the EMA, FDA and PMDA
- Performance Testing of Safety System
