Tag: ICH Q9

Electronic Lab Notebook / Data Capture (if used for GMP) – Deviation Impact Assessment

Deviation Impact Assessment Template Equipment Information Equipment: Electronic Lab Notebook / Data Capture (if used for GMP) Area: System Criticality: Indirect Product Impact: Electronic records for GMP decisions Deviation Details Deviation Description: Classification Classification: Minor Major Critical Product/Patient Impact Product/Patient…

Electronic Lab Notebook / Data Capture (if used for GMP) – PQ Protocol

Document Control Number: PQ-ELN-001 Version: 1.0 Effective Date: [Insert Date] Reviewed by: [Insert Name] Approval Date: [Insert Date] Performance Qualification Protocol for Electronic Lab Notebook Objective: To validate the Electronic Lab Notebook (ELN) software for compliance with GMP requirements, ensuring…

Electronic Lab Notebook / Data Capture (if used for GMP) – OQ Protocol

Operational Qualification Protocol for Electronic Lab Notebook in NDDS Document Number: OQ-ELN-001 Version: 1.0 Effective Date: 2023-10-01 Prepared By: [Name] Approved By: [Name] Objective The objective of this Operational Qualification (OQ) protocol is to verify that the Electronic Lab Notebook…

Electronic Lab Notebook / Data Capture (if used for GMP) – IQ Protocol

Installation Qualification Protocol for Electronic Lab Notebook in R&D/QC Document Number: IQ-ELN-001 Version: 1.0 Effective Date: [Insert Date] Prepared By: [Insert Name] Approved By: [Insert Name] Objective The objective of this Installation Qualification (IQ) protocol is to verify that the…