Project Planning
Computer System and Software Validation
Risk Assessment and Analysis for 21 CFR part 11 compliance
Computer System Remediation
Software Development
User Acceptance Testing
Factory Acceptance Testing
Developing URS, FRS, and SRS
Installation Qualification (IQ)Plan
Operational Qualification (OQ) Plan
Performance Qualification (PQ) Plan
Validation Protocols IQ, OQ, PQ
Validation Protocol Execution
Validation Reports
Traceability Matrix
Writing SOPs
System Audit and Review Software Development Services