Independent Solutions provide full System Life-Cycle (SLC) validation for computer systems ranging from small systems to large-scale (Enterprise Resource Planning) systems in accordance with site requirements, GAMP, FDA & EU standards. This involves the development & execution (where applicable) of the following documentation:
Regulatory Assessment
Project Scope
Validation Project Plan (VPP)
User Requirements Specification (URS)
Functional Specification (FS)
Functional Design Specification (FDS)
Hardware Design Specification (HDS)
Configuration Specifications (CS)
Risk Assessments
Part 11 Compliance Assessment
Factory Acceptance Test (FAT)
Site Acceptance Test (SAT)
Supplier Auditing
Installation Qualification (IQ) protocols and Reports
Operational Qualification (OQ) protocols and Reports
Performance Qualification (PQ) protocols and Reports
Performance Monitoring Protocol
Requirements Traceability Matrix (RTM)
Validation Summary Report
Computer Systems Decommissioning
SOP development
Disaster Recovery Plan
Business Continuity Plan
Periodic Review
Training Plans
Contact us to discuss your requirements.
Chromatography Systems
Labelling Systems
ERP Systems
Laboratory Systems
Calibration Systems