Annex 15 – Page 20 – Pharma Validation

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…

Electronic Lab Notebook / Data Capture (if used for GMP) – Equipment Validation SOP

Standard Operating Procedure for Equipment Validation of Electronic Lab Notebook in NDDS Purpose: This SOP outlines the processes for validating Electronic Lab Notebook software utilized in the Research and Development (R&D) and Quality Control (QC) environments, ensuring compliance with Good…

NDDS Process Control System (PLC/SCADA for microfluidics/homogenizer/TFF) – Qualification Certificate Template

Qualification Certificate Equipment: NDDS Process Control System (PLC/SCADA for microfluidics/homogenizer/TFF) Subcategory: NDDS – CSV / Data Integrity for NDDS Area: Production Qualification Flags DQ: Yes IQ: Yes OQ: Yes PQ: Yes Requalification Frequency After Change Equipment Identifiers Serial Number: [Insert…

NDDS Process Control System (PLC/SCADA for microfluidics/homogenizer/TFF) – Traceability Matrix (URS ↔ Tests)

URS ID URS Statement Risk (H/M/L) DQ Test Ref IQ Test Ref OQ Test Ref PQ Test Ref Evidence/Record Result URS-001 Ensure audit trail access control is functional to maintain data integrity. H DQ-001 IQ-001 OQ-001 PQ-001 Audit Trail Log…

NDDS Process Control System (PLC/SCADA for microfluidics/homogenizer/TFF) – Validation Summary Report (VSR) Template

Validation Summary Report (VSR) Summary This Validation Summary Report (VSR) provides an overview of the validation activities performed for the NDDS Process Control System, encompassing the PLC/SCADA used for microfluidics, homogenization, and tangential flow filtration (TFF). The report outlines the…

NDDS Process Control System (PLC/SCADA for microfluidics/homogenizer/TFF) – Deviation Impact Assessment

Deviation Impact Assessment Template Equipment Details Equipment: NDDS Process Control System (PLC/SCADA for microfluidics/homogenizer/TFF) Area: Production Criticality: Critical Product Impact: Direct CSV Required: Yes Deviation Details Deviation Description: [Insert deviation description] Deviation Date: [Insert date] Reported By: [Insert name] Classification…

NDDS Process Control System (PLC/SCADA for microfluidics/homogenizer/TFF) – Qualification Execution Checklist

Qualification Execution Checklist Equipment: NDDS Process Control System (PLC/SCADA for microfluidics/homogenizer/TFF) Subcategory: NDDS – CSV / Data Integrity for NDDS Area: Production DQ/IQ/OQ/PQ Flags: Yes/Yes/Yes/Yes CSV Required: Yes Pre-start Training completed SOPs reviewed and approved URS approved RA approved Calibration/PM…

NDDS Process Control System (PLC/SCADA for microfluidics/homogenizer/TFF) – PQ Protocol

Document Control Document ID: PQ-NDDS-001 Version: 1.0 Effective Date: YYYY-MM-DD Reviewed By: [Reviewer Name] Approval Date: YYYY-MM-DD Performance Qualification Protocol for NDDS Process Control System Meta Description: This document outlines the Performance Qualification Protocol for the NDDS Process Control System,…

NDDS Process Control System (PLC/SCADA for microfluidics/homogenizer/TFF) – OQ Protocol

Document Control Document Number: OQ-001 Revision: 1.0 Date: 2023-10-01 Prepared By: Validation Team Approved By: QA Manager Operational Qualification Protocol for NDDS Process Control System Objective: To validate the NDDS Process Control System (PLC/SCADA) to ensure it meets the specified…