Prepare installation qualification protocol report

Assignment Help Science

Reference no: EM132430271 , Length: 14 pages

Prepare Installation Qualification Protocol Report

Title Page
-Header
-Title of the project
-Name of the equipment
-Protocol/Document No.

Table of Contents
-Located at the beginning of the protocol
-Page numbers

Header
-Must be on all pages
-Should include, at a minimum, the following:
Document No., Title, Company Information, Page No. (X of Y format), Revision No., Prepared By

Signatures Page
-Name, Position, Signature, Initials of all individuals involved in the execution of the protocol
-Reviewed and Signed
Aligns with responsibility and training section

Document History
-A summary of changes
- Include, at a minimum, the following:
Date, Description of Change, Reason for Change, Changed By

Objective
-Purpose of the protocol

Scope
-Description of what the protocol covers

Introduction
-Reference to Validation Master Plan (VMP)
-Reference to applicable guidance documents

References
-All documents/& manuals that are mentioned in the protocol and utilized during execution are listed (Document name, Document No.)
-USP general chapter

Responsibility
-Description of which departments are involved in the execution of the protocol and their responsibilities
-Including: positions, contractors, consultants, vendor
Aligns with signature page and training

Procedure - General Execution Instructions
-General description of how the protocol should be executed (GDP Rules, Training Requirements, Precautions, etc.)

Visual Inspection
-Verification of safe arrival of the equipment (Damages, Serial No., etc. verified)

Utility Verification
-Verification that available utility is as required, suitability of conditions (Ex. Voltage, Space)

Environmental Conditions
- Verification that available conditions are as required, suitability of conditions (Ex. Temp., Humidity)

Testing Equipment/Measuring Devices
-List all measuring devices used in the project. Including, at a minimum, the following: ID No., Calibration Certificates, Location, Calibration Expiry date verified

Equipment Related Documents
-List all equipment documents, including, at a minimum, Document No., Location, Type of Document, Training Records, Verification

Hook up and Instrumentation, Installation Procedure
-Stepwise verificationof assembly and hook up of the equipment
-Verification of
availability of all purported functions and their correct functioning

Exceptions/Deviations
-List of all deviations, investigations and corrective actions
-Verification that all deviations are resolved before execution signed off

Summary - Complete/Pass/Fail
-Conclusion
-Statement: installation completed/Passed/Failed

Attachment:- Rubrics Protocol Report.rar

Reference no: EM132430271

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