Software Validation Protocol of Equipment

1.0 PURPOSE:

This Validation Plan gives the overview of control systems designed & procedures implemented in the organization to meet the cGMP requirements, latest international standards and guidelines such as GAMP5, EU Annexure-11 & US FDA 21 CFR Part 11.

It describes the scope of activities, within which validation of control system is to be performed and provides an overview of the planning status.

This Validation Plan is generated under validation policy of the company.

2.0 OBJETIVE:

To ensure that the control system properly supports the process.

To ensure that the control system has been properly installed, is operated correctly,  and  that procedures and practices are in place to allow it to be maintained in a state of control throughout its useful life.

To establish a complete set of system documentation providing a precise definition of the operating environment, functionality, hardware and software, procedures and  reference  manuals  associated  with the control system.

3.0 SCOPE:

This document provides broad guidelines to be followed and implements the concept for control system validation as per the best understanding of Good Automated Manufacturing Practices (GAMP5), EU Annexure-11 & US FDA 21 CFR Part 11.

This Validation Plan applies to all existing & incoming equipment/instruments with control system (PLC/SCADA/IPC system) that is used for control, create, modify, archive and retrieve the data generated during the process. This includes equipments, instruments and computers that are used to acquire and evaluate data.

This plan describes the test procedures, documentation, references & acceptance criteria for performing Validation of Control System.

This document describes the details of the validation activities that will be conducted during the system life cycle of the PLC/SCADA/IPC system of XYZ Site Name

Specifically, this document defines the approach for providing documented evidence that the above system performs its various functions correctly, consistently and according to the design requirements and system definitions and will continue to do so in the future.

The validation will include the programmable logic controller performance and operational qualification document of the PLC/SCADA/IPC system once the installation qualification document of the programmable logic controller system has been completed. Qualification activities will include the associated interfacing hardware and software.

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1.0 Objective

The purpose of this document is to provide pragmatic approach for the Computerized System Validation. The purpose of this validation master plan is:

• To define the company’s philosophy and commitment to validation and the overall structure for validation activities.
• To define the roles and responsibilities of persons involving in validation activities.
• To describe the methodology and guide the technical team executing the validation activities.
• To prepare and follow validation schedules.

2.0 Scope

The scope of the document is limited to the computerized systems; only those items which could affect the quality of products and the quality of the data generated to support their regulatory submissions will be validated. Consequently, there may be systems, whose operation, although important for the efficient and economic operation of the facility, can not be considered critical to the quality of product and therefore will not be validated as part of this activity.

Listed below are the types of computer systems that will be validated.

• Computer systems handling GMP data (Lab Systems with Software)

• PLC based process control system

• SCADA based process control system

3.0 Facility Description And Design

3.1  General Description and Design Concept

This facility is having manufacturing plants with automated equipments as well as computerised laboratory systems.

4.0  Periodic Review

The computer system validation master plan is reviewed once in every two years to ensure compliance and to determine whether a change is required due to following reasons.

• Changes in Validation policy and design.

• Major Modification or renovation of existing facility.

• To fulfill any regulatory requirement, GMP requirement and current Industrial Practices.

Should any modifications in the templates occurs, these shall be approved by the same team members (or their designee) authorizing this VMP. The superseded templates shall be retained with relevant revision of the VMP. All the changes made shall be addressed through change control procedure.

5.0 Validation Policy

The company is committed to the concept of validation and all computer system handling GMP data, and automated process control system are put through qualification and validation cycles before being accepted for use.

• Validation shall be used as a tool for providing a high degree of assurance that a specific system, process or facility will consistently produce a product meeting its pre-determined specification and quality attributes.
• All GMP and GLP requirements shall be considered right from the design and subsequent qualification.
• Changes (those impacting the Quality, safety & efficacy of the product) including the replacement of critical parts or any major modifications made to the equipment shall be subjected for re-qualification.

6.0 Validation Personnel

Computer System validation will involve two main groups. Thes site Validation team is responsible for planning and overview of all validation activities and the external Validation agency is responsible for documentation and execution of specific validation projects along with site Validation team.

For each individual validation study a Validation Team will be appointed. The members of the Validation Team and their responsibilities for each individual study will be identified in the project specific validation document

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