Tag: Annex 15

AHU for Aseptic Area – IQ Protocol

Document Control Document Number: IQ-AHU-001 Version: 1.0 Effective Date: [Insert Date] Review Date: [Insert Date] Prepared By: [Insert Name] Approved By: [Insert Name] Installation Qualification Protocol for AHU in Aseptic Area Meta Description: This document outlines the Installation Qualification (IQ)…

AHU for Aseptic Area – DQ Protocol

Design Qualification Protocol for AHU in Aseptic Area Document Control Number: DQ-AHU-001 Version: 1.0 Effective Date: [Insert Date] Review Date: [Insert Date] Objective The objective of this Design Qualification (DQ) protocol is to validate the Air Handling Unit (AHU) for…

AHU for Aseptic Area – Equipment Validation SOP

Standard Operating Procedure for Equipment Validation of AHU in Aseptic Areas Purpose This SOP outlines the validation process for the Air Handling Unit (AHU) used in the Aseptic Area, ensuring compliance with regulatory standards and maintaining product integrity. Scope This…

SCADA System – Qualification Certificate Template

Qualification Certificate Equipment Information Equipment: SCADA System Subcategory: Computerized Systems (Manufacturing Automation) Area: Production Equipment Identifier: [Equipment Identifier] Qualification Status DQ (Design Qualification): Yes IQ (Installation Qualification): Yes OQ (Operational Qualification): Yes PQ (Performance Qualification): Yes Protocol References Protocol References:…

SCADA System – 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 The SCADA System must provide an audit trail for all user activities. H DQ-001 IQ-001 OQ-001 PQ-001 Audit Trail…

SCADA System – Validation Summary Report (VSR) Template

Validation Summary Report (VSR) Summary This Validation Summary Report documents the validation activities performed for the SCADA System used in the Production area. The validation encompasses Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) in…

SCADA System – Deviation Impact Assessment

Deviation Impact Assessment Template Equipment Details Equipment: SCADA System Area: Production Criticality: Critical Product Impact: Direct CSV Required: Yes Deviation Details Description: [Insert deviation description here] Date of Deviation: [Insert date] Reported By: [Insert name] Classification Type: [Insert classification type]…

SCADA System – Qualification Execution Checklist

Qualification Execution Checklist for SCADA System Equipment: SCADA System Subcategory: Computerized Systems (Manufacturing Automation) Area: Production DQ/IQ/OQ/PQ Flags: Yes/Yes/Yes/Yes CSV Required: Yes Pre-start Checks Training completed SOPs reviewed and approved User Requirement Specification (URS) approved Risk Assessment (RA) approved Calibration/PM…

SCADA System – PQ Protocol

Document Control Number: PQ-SCADA-001 Version: 1.0 Effective Date: [Insert Date] Review Date: [Insert Date] Performance Qualification Protocol for SCADA System Objective: The purpose of this Performance Qualification (PQ) Protocol is to validate the SCADA System used for supervisory control and…

SCADA System – OQ Protocol

Document Number: OQ-001 Version: 1.0 Effective Date: [Insert Date] Reviewed By: [Insert Name] Approval Date: [Insert Date] Operational Qualification Protocol for SCADA System in Manufacturing Automation Objective: The objective of this Operational Qualification (OQ) protocol is to verify that the…