PLC Validation

U Med Laboratories covers various equipments/machines with their own PLC based Automation System as well as will be procuring similar automated equipment for their future requirements.

The equipments the Building designs incorporate Good Manufacturing Practices and are based on International Regulatory requirements and current technological advancements.

U Med Laboratories strongly believes that Validation is a necessary part of a quality assurance program. It is a fundamental to build system in the quality of the products and achieving consistency and efficiency in manufacturing operations.

Master Validation Plan covers the equipment having Programmable Logic Controller based systems.  It defines the extent of the validation program and lays down broad guideline for the various validation activities to be carried out in line with the validation .

PLC PROTOCOL WILL COVER AS FALLOWS:

                                               

1.0          INTRODUCTION                                                                                   

2.1          Scope   

2.1.1       Objective

2.1.2       System Description

2.1.3       Scope & Applicability

2.1.4       Level of Detail

2.1.5       Electrical

2.0          ORGANISATIONAL STRUCTURE                                                         

3.1          Responsibilities

4.0        VALIDATION STRATEGY AND DELIVERABLES                                   

4.1           General

4.1.1       List of the PLCs

4.1.2       Documentation

4.1.3       Instrument Inspection and Calibrations

5.0        QUALIFICATION PROTOCOLS                                                

5.1          Control System Installation Qualification (CIQ)

5.1.1       Equipment Details

5.1.2       Verification of Master Documents

5.1.3       Verification of Engineering Drawings (“ As Built”)

5.1.4       Verification of PLC system Hardware Components

5.1.5       Verification of Communication Cables

5.1.6       Verification of PLC Panel Arrangement

5.1.7       Verification of Power Utility

5.1.8       Verification of Software Backup

5.1.9       Verification of Software Configuration and Source Code

5.1.10     General System Inspection for PLC Panel

5.1.11     Programmable Function Keys (PFKs) and Displays Verification

5.2          Control System Operation Qualification (COQ)

5.2.1       Testing of PLC Processor

5.2.2       Testing of PLC Inputs / Outputs

5.2.3       Testing of System Security

5.2.4       Testing of Programmable Function Keys (PFKS) and Displays

5.2.5       Verification of Environmental Conditions

5.2.6       Testing of Power Failure Conditions

5.2.7       Testing of Communication Failure Conditions

5.2.8       Testing of Alarm / Messages

5.2.9.      Operational Testing

5.2.10.    Review of Relevant Sops for the PLC System

5.2.11.    Verification of System behavior as per the USFDA 21 CFR Part 11 Clauses

5.3          Discrepancy Report

5.4          Validation Report

6.0          VALIDATION EXECUTION AND DELIVARABLE                        

7.0          ACCEPTANCE CRITERIA                                                                        

8.0          CHANGE CONTROL                                                                             

9.0          TRAINING REQUIREMENT                                                                   

9.1          Selection and Training

9.2           Education / Training

10.0        DOCUMENTATION REQUIREMENT                                                         

11.0        MAINTAINING THE VALIDATED STATE                                                 

12.0        TERMINOLOGY                                                                                     

           

REFERENCES