FDA Validation

Lynx understands the challenges FDA regulated companies face with the on-going changes, implementing new technologies, and maintaining a compliant system.

Experience / Capabilities
… Computer Systems — HMI, SCADA, LIMS, MES, ERP
… Process — Cleaning
… Equipment — Utilities, HVAC
… Automation & Controls — PLCs, SCADA, DCS
… cGMP, GAMP
… System Development Life Cycle
… 21 CFR Part 11 Regulations
… Risk Based Approach
… SOP Development
… Infrastructure Building, Security, Alarms, Etc.

Validation Deliverables
… Validation Master Plan (VMP)
… User Requirement Specifications (URS)
… Functional Specifications (FS)
… Design Specifications (DS)
… Factory Acceptance Test (FAT)
… Site Acceptance Test (SAT)
… IQ/OQ/PQ Protocols Development Signoff /Execution / Approval
… Traceability Matrix
… Deviations and Resolution
… Summary Report

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