GxP ELN Validation Documentation

I need a complete Computer System Validation (CSV) package for an open-source Electronic Labbook that will be deployed in a GMP environment. The system handles routine data entry and management, maintains audit trails with electronic signatures, and must demonstrably comply with GAMP 5 and 21 CFR Part 11. Your work will be used directly in a pharmaceutical quality dossier, so every document has to stand up to regulatory scrutiny. Scope of work The immediate focus is on authoring and executing the full suite of validation documentation, beginning with a risk-based approach and ending in a defensible summary report. Highest-priority items are the URS, OQ, and overall Risk Assessment, but the project is only complete when the entire package is delivered and traceable. Expected deliverables • Validation Plan and risk assessment that classify functions such as data entry, audit trails, e-signatures and system security • User Requirement Specification (URS) aligned with GAMP 5 category guidance • Installation, Operational and Performance Qualifications (IQ/OQ/PQ) including test scripts and objective evidence • Traceability Matrix linking requirements, tests and results • Validation Summary Report consolidating findings and release decision • SOP templates for operation, maintenance and change control in the GMP setting Acceptance criteria – Documents follow current ISPE GAMP 5 terminology and structure – All test evidence is reproducible and references raw data where applicable – Traceability Matrix shows 100 % coverage from URS through PQ results – Language, formatting and version control align with our corporate SOPs (to be shared after NDA) I will provide system architecture details, existing user stories and access to the staging instance once a mutual NDA is in place. Prior hands-on experience validating lab informatics in pharma or biotech is essential; please confirm when you submit your approach and timeline.

Project ID: 39755377