CDC Ross ERP Validation Packages :
Protocols, Tools and Consulting Services for Step-by-Step Validation
Ross ERP provides Validation Documentation, Protocols, Tool Kits and Full Cycle Services for our suite of content and quality management software products. Through these comprehensive validation packages, our customers are provided all the detailed information needed to ensure that proper validation is performed to fulfill Good Manufacturing Practice (GMP) guide-lines and that compliance with 21 CFR Part 11 is achieved.
Our Validation Toolkit includes documentation templates for:
- CSV policies and procedures
- Validation plan template
- Risk management plan
- User requirements specification templates
- Functional requirements specification templates
- Operational qualification (OQ) test traceability
- System operational SOPs
- Performance qualification template
- Validation report template
- Change control and continuous monitoring SOP templates
- FDA uniform Audit Response form
Get all the details.