Tag: Annex 11

Device Inspection System (Vision/Microscopy) – Qualification Execution Checklist

Qualification Execution Checklist Equipment: Device Inspection System (Vision/Microscopy) Subcategory: NDDS – Drug-Eluting Stents / Coated Devices Area: QC/R&D DQ/IQ/OQ/PQ Flags: Yes/Yes/Yes/Yes CSV Required: Yes Pre-start Training completed SOPs approved URS approved RA approved Calibration/PM Status Verification Calibration status verified PM…

Device Inspection System (Vision/Microscopy) – PQ Protocol

Document Control Number: PQ-ED-001 Version: 1.0 Effective Date: [Insert Date] Review Date: [Insert Date] Performance Qualification Protocol for Device Inspection System in NDDS – Drug-Eluting Stents This document outlines the Performance Qualification (PQ) protocol for the Device Inspection System used…

Device Inspection System (Vision/Microscopy) – OQ Protocol

Document Control Protocol Number: OQ-DEV-INS-001 Version: 1.0 Effective Date: [Insert Date] Review Date: [Insert Date] Prepared By: [Name] Approved By: [Name] Operational Qualification Protocol for Device Inspection System Objective: To validate the Device Inspection System for inspecting coating defects and…

Device Inspection System (Vision/Microscopy) – IQ Protocol

Installation Qualification Protocol for Device Inspection System in NDDS Document Number: IQ-DS-001 Version: 1.0 Effective Date: [Insert Date] Review Date: [Insert Date] Objective The objective of this Installation Qualification (IQ) protocol is to verify that the Device Inspection System (Vision/Microscopy)…

Device Inspection System (Vision/Microscopy) – DQ Protocol

Document Control Number: DQ-001 Version: 1.0 Effective Date: 2023-10-01 Prepared by: [Your Name] Approved by: [Approver Name] Design Qualification Protocol for Device Inspection System Meta Description: This document outlines the Design Qualification Protocol for the Device Inspection System used in…

Labeling Machine (Bag/Bottle) – Qualification Certificate Template

Qualification Certificate Equipment Information Equipment: Labeling Machine (Bag/Bottle) Subcategory: IV Infusions (LVP/SVP – Bags/Bottles) Area: Packaging/Primary Qualification Flags DQ: Yes IQ: Yes OQ: Yes PQ: Yes Qualification Details Requalification Frequency: 12 Months Equipment Identifiers: [Insert Equipment Identifiers] Protocol References: [Insert…

Labeling Machine (Bag/Bottle) – Validation Summary Report (VSR) Template

Validation Summary Report (VSR) Summary This Validation Summary Report outlines the validation activities conducted for the Labeling Machine used in the packaging of IV Infusions (LVP/SVP – Bags/Bottles). The report summarizes the Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification…

Labeling Machine (Bag/Bottle) – Deviation Impact Assessment

Deviation Impact Assessment Template Equipment Details Equipment: Labeling Machine (Bag/Bottle) Area: Packaging/Primary Criticality: Critical Product Impact: Direct CSV Required: Yes Deviation Details Deviation Description: [Insert description of the deviation] Date of Deviation: [Insert date] Reported By: [Insert name] Classification Deviation…