We follow GAMP4 and Specialize in Controls & Computer Systems Validation

Validation Planning

Requirements Definition

Detailed Design Specifications

Test Plans

Traceability Matrix

Generate Standard Operating Procedures (SOPs)

Generate Installation Qualification Protocols (IQ)

Generate Operational Qualification Protocols (OQ)

Generate Performance Qualification Protocols (PQ)

Perform Protocol Execution

Perform Validation Support

Perform Retrospective Validation

Experience with 21 CFR Part 11 Compliance and Validation

Generate Summary Reports