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Computer Systems and Software Validation
Computerized Systems that perform regulated functions must be qualified or validated. Computerized Systems may include networks (wired and wireless), workstations, operating system software, application software, instrument software, equipment software, and interfaces with other computerized systems.
PSC offers a complete range of services for your computer validation needs. We EXCEL at SAP, TrackWise, Delta V, and custom software validations! We offer complete outsourced Quality Assurance services for software implementation and validation projects!
- Preparation of Software Validation documents:
- User Requirements Specifications (URS)
- Functional Requirements Specifications (FRS)
- Software Requirements Specifications (SRS)
- Validation Master Plan
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
- Risk Assessment
- Hazard Analysis
- Traceability Matrix
- Validation SOPs
- Execution of Validation Protocols and resolution of deviations
- Network Qualification
- Server Qualification
- 21 CFR Part 11 Gap Analysis, remediation, and validation
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