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Computer Systems Validation
Specification Development
We can assist you in the development of computer system documentation in compliance with industry standards as well as Good Automated Manufacturing Practices® (GAMP), including:
- User Requirements Specifications (URS)
- Supplier/Vendor Audits
- Functional Specifications (FS)
- Design Specifications (DS)
- Validation Master Planning (VMP)
- Software Development Life Cycle (SDLC)
System Design Services
Our professionals are trained to provide a full gamut of design services ranging from the initial concept through full system integration. Available services include:
- Design Review
- Unit Testing
- Integration Testing
- System Testing System
Procurement and Installation
Our organization can assist in solutions for any size system including:
- Project Management
- Gap Assessment
- Risk Assessment
- Vendor Leveraging
Commissioning, Qualification and Validation Services
We can provide document development and execution services for computer hardware or software systems large or small. These services include:
- Factory Acceptance Testing (FAT)
- Site Acceptance Testing (SAT)
- Commissioning Testing
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
- Requirements Traceability
System Type Expertise includes the following:
- Building, Facility, Utility Systems
- Infrastructure
- IT Applications
- Laboratory Systems
- Process Control Systems
- Enterprise Level Systems
Customer Support and Training
Our team is available to provide on-going system support and training services to supplement your company's personnel resources including, but not limited to:
- Backup and Recovery
- Data Archiving
- Continuity Planning
- Disaster Recovery
- Periodic System Reviews
- Surveillance Audits
- ISO/QMS Reviews
- Best Practices Training
- SOP Development
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