Smartlogic

ולידציה – Validation case study – part 2

ולידציה – Validation case study – part 2

 This article was written by Iian Shaya, validation,automation and control expert

Validation Requirements

Documentation for Initial Tender

Project schedule and milestones design and construction detail

Project quality plan

Supplier’s local subsidiary/agent

Supplier’s documentation that the system / configurable software versions are released to the market and are FDA/EMEA compliant

Compliance to the 21 CFR Part 11 operational requirements – the contractor should ensure covering of all the requirements described below

Contractor to state the system/product status and implementation planned for each requirement – User's approval pre-delivery

Documentation for Design Review

PID for the system

Electrical and pneumatic schematics

:Installation data

General arrangement drawings

Floor loading

Utility requirements

Details of electronic records and approvals that may be subject to regulatory controls under CFR Title 21 part 11

Instrumentation documentation

:Main components specification

Equipment

Instrumentation

Valves

Piping

Control system

Pipe welding documentation

General installation book

Procedures

User guide

Security

Preventative maintenance + spare parts list

Operation procedure

Pressure test procedure

Leak test procedure

Passivation procedure

Calibration

:Functional Design Specifications for

Complete manufacturing system

Software – SW and hardware –HW

Functional Design Specifications

System Detail Design Specifications for HW and SW.

SW source code, with comments, for customized SW

SW complete version history

HMI alarm list, message list and graphical displays

I/O list

:List of materials

Product contact materials

Potential product contact lubricants

Welding procedures for product direct and indirect contact parts

Pre-delivery Inspection and Factory Acceptance Test (FAT) protocols

Steel certificates and gasket certificates

Documentation Prior to FAT or Pre-Delivery Inspection – PDI

:Progress visit report which will include

Mechanical and technical development

Automation and SW development

:Supplier’s factory test results for

Unit tests – The test protocols shall be traced to low level design document and will be approved by the user prior to execution. The approval of the report shall be performed by representatives of the user's validation team, IT QA.

Automation and SW development

:Integration Tests  – Simulation Testing

Approved PDI and FAT protocols

Commissioning

MCCR

Purpose

Scope

Responsibility

Execution instructions

System scope

System description

Drawing verification

Equipment verification

Valve verification

Instrument installation and calibration

Utility verification

Documentations verification

Piping Verification

Sample Point Verification

Safety, health and environment verification

Slopes verification (if relevant)

Electrical and communication activities

Pump installation verification, if relevant

Heat exchanger installation verification, if relevant

Air break verification, if relevant

Dead leg verification, if relevant

CE

Purpose

Scope

Responsibility

Execution instructions

System scope

System description

System startup

Equipment verification

Main equipment operation checks

System FDS (SSO) verification

System performance testing

 This article was written by Iian Shaya, validation,automation and control expert

ולידציה – Function Design Specification – FDS

ולידציה – Function Design Specification – FDS

 This article was written by Iian Shaya, validation,automation and control expert

The Function Design Specification (FDS) is part of the validation documentation that details the solution to be provided to meet the user's requirements. It should be approved by the user and should form the basis of the design for both hardware (HW) and software (SW) designs.

The FDS provides the basis of the design of the system and is used to verify and validate the system during the testing, ensuring all the required functions are present and that they operate correctly. It details all the functions, operator interactions control and sequencing associated with the system, thus allowing the user to confirm, before the system is developed that the proposed solution fully meets its requirements.

FDS Contents

The FDS is structured in a relatively standard fashion, with predetermined chapters and sections, where the final contents are tailored according to the type and size of the system under validation. The FDS presented here includes only to the technical contents. It does not include commercial and contractual requirements, which may also be generally included.

The main chapters and sections of an FDS protocol are:

Relationship to Other Documents – lists all documentation used in the production of the FDS. Includes suppliers' documents (such as URS) and drawings. Each document listed should include the document/drawing number and version number. This allows traceability as documents are updated throughout the project life cycle on any impact on the FDS.

System Overview

Process Overview – includes a description of the process being controlled; this may be taken from the URS, enhancing to detail the interaction with the control system.

Control System Overview – includes detailed control system description, with all the components and interaction between the systems; block and network diagrams can be used to show in detail the system architecture

Scope and Limits of Supply

Scope of Supply – includes a list of deliverables, panels, computers, software, etc

Limits of Supply – includes all items outside the scope of the supply required by the project; where interfacing to 3rd party systems, constraints and assumptions should be included

System Functions and Facilities

Operation Modes – includes all modes of operation for the system

Functional Operation – divides each of the sequences functions into logical areas (determined by the process), and provide complete description of each area

Operator Requirements – describes the interface between the operator and the detailed function

Human/Machine Interface- HMI – details all points of operation, local terminals, remote terminal, message displays, push button stations, etc.

Report Outputs – the format of all reports generated by the system should be detailed, and that the format and explanation of the report contents should be included

System Data – all data gathered, generated or calculated by the system should be detailed

System Interfaces – provide complete details of all inputs and outputs from the control system

System Attributes

Availability – defines expected "working" time of the system between failures

Maintainability – details issues related to maintainability of the plant, in particular for systems that require regular maintenance to ensure the reliable operation

Transport and off loading

Power and services required

Connections to existing/3rd party systems

Changes to existing plant or hardware (HW) equipment

Changes to existing software (SW) systems

Training – details the formal and informal training to be supplied under the contract

Design Factors – details special factors relating to the design of the system, standards and methodologies to be followed for both the HW and SW development

Development Factors

Project Control – includes or makes reference to project plans and timescales, along with details of quality requirements, standards, test and integration and configuration management

Resource Requirements – includes the basic project team provided by the supplier, the access required to the customer's premises, and input and timing required by the customer into the project

Test procedures – including details of all test documentation and responsibilities for testing both offline and online

Module and Integration Testing

Factory Acceptance Testing (FAT) – performed at the suppliers premises

Site Acceptance Testing (SAT) – performed on completion of commissioning to demonstrate pre-handover system operation

:Note

As the final contents of the FDS are tailored according to the type and size of the system under validation, and this document is generic, it covers test procedures that may not be necessary in small or simple systems. The following sections cover the FDS issues that require further details

 About the system functions and facilities in our next article FSD System Function & Facilities

 This article was written by Iian Shaya, validation,automation and control expert

אילן שעיה ilan Shaya

ולידציה – FRS – Regulatory & HMI Requirements

ולידציה – FRS – Regulatory & HMI Requirements

 This article was written by Iian Shaya, validation,automation and control expert

Regulatory Requirements

These requirements cover all the FDA specifications regarding the system compliance with the 21 CFR Part 11 definitions, and also with usual validation documentation demands

Method to provide a computerized system that complies with 21 CFR Part 11 definitions, such as the system access control by the user's managing personnel, who shall be responsible for the content of the electronic records (ERs) contained in the system

Method to restrict logical access to the system according to specified authorization levels

Method to restrict logical access to the system only to specific user ID and password

Method to provide system capability to record the values, alarms, user changes and any other events, and provide readable forms and reports of ER data

Method to allow storage of historical events, current alarms and historical alarms data records on the computerized system database

Capability of data display to the user in "view only" mode, so the user cannot alter or delete data/records

Provision of user's capability to backup data daily, weekly and monthly, according to his procedures, to ensure protection of the records and to enable their accurate and ready retrieval throughout the records retention period

Provision by the supplier of a project plan and quality assurance (QA) processes during development and the testing stages as part of his QA systems

Provision by the supplier of the following documents

Functional Requirements Specification – FRS

Functional Design Specification- FDS

IO List

Schedule of System Operation – SSO

Installation Qualification (IQ) protocol

Operation Qualification (OQ) protocol

Performance Qualification (PQ) protocol

HMI Requirements

These requirements are intended to provide the URS demands from the HMI screens, regarding proper graphic design and functionality for controlling and monitoring the system, as specified in customer's contract with the supplier. The HMI screens provided usually are of the following types

Main Screen

Synoptic screens for displaying online values and status

Parameters screens for displaying temperature, humidity and pressure parameters values

Data logging and storage of historical trends, alarms and events

Tabular screens for displaying alarms

Graphical screens for displaying trends

 This article was written by Iian Shaya, validation,automation and control expert

ולידציה – URS – Regulatory & HMI Requirements

ולידציה – URS – Regulatory & HMI Requirements

 This article was written by Iian Shaya, validation,automation and control expert

Regulatory Requirements

These requirements cover all the FDA specifications regarding the system compliance with the 21 CFR Part 11 definitions, and also with usual validation documentation demands

Computerized system compliance with 21 CFR Part 11 definitions, such as the system access control by the user's managing personnel, who shall be responsible for the content of the electronic records (ERs) contained in the system

System capability of restricting logical access to the system according to specified authorization levels.

Access to the system allowed only by user ID and a specific password

System capability to record the values, alarms, user changes and any other events, and provide readable forms and reports of ER data

Storage of historical events, current alarms and historical alarms data records on the computerized system database

Data display to the user in "view only" mode, so the user cannot alter or delete data/records

Provision of user's capability to backup data daily, weekly and monthly, according to his procedures, to ensure protection of the records and to enable their accurate and ready retrieval throughout the records retention period.

Provision by the supplier of a project plan and quality assurance (QA) processes during development and the testing stages as part of his QA systems

Provision by the supplier of the following documents

Functional Requirements Specification –FRS.

Functional Design Specification – FDS

IO List

Schedule of System Operation – SSO

Installation Qualification (IQ) protocol.

Operation Qualification (OQ) protocol

Performance Qualification (PQ) protoco

HMI Requirements

These requirements cover the provisions demanded from the HMI screens, regarding proper graphic design and functionality for controlling and monitoring the system, as specified in customer's contract with the supplier

:Note

The final contents of the URS and FRS are tailored according to the type and size of the system under validation. Since the URS and FRS regarded herein are generic, they include requirements that may not be necessary in small or simple systems

 This article was written by Iian Shaya, validation,automation and control expert

ולידציה – DQ – Design Review

 ולידציה – DQ – Design Qualification / Design Review

DQ  – Design Qualification is for Design Review by verifying that the system has been designed as specified in the URS (User Requirements Specification), FDS (Functional Design Specification), and relevant equipment specifications satisfying all GMP requirements. The Process User Requirements in the URS have been identified by the Quality Risk Assessment. Since the Quality Risk Assessment is an iterative process, it may be performed again, whenever necessary, during the DQ and subsequent lifecycle qualifications.  For  hardware and software of the control system, verification data will be collected to prove that the system has been designed in accordance with the URS and FDS including the requirements of 21 CFR Part 11. As DQ is the final step to formally review and document the proper design of the system, the protocol must enable the reviewers to verify that all quality-critical attributes and essential technical attributes of the system have been incorporated in the design. When the DQ report is approved, the system is ready for fabrication and construction.

DQ PROTOCOLS
PROCESS EQUIPMENT AND SYSTEMS
Media Preparation and Hold Tanks
Buffer Preparation and Hold Tanks
Process Tanks
Reactors – Organic Synthesis
Bioreactors
Evaporator Systems
Distillation Tower Systems

CLEAN UTILITY SYSTEMS
USP Purified Water Storage and Distribution Systems
WFI Storage and Distribution Systems
Clean Steam Generation and Distribution Systems
Process Air Systems
Nitrogen Gas Systems

SUPPORT SYSTEMS
CIP Systems
Biowaste Kill Systems – Continuous
Biowaste Kill Systems – Batch
Autoclaves

HVAC SYSTEMS AND CLEANROOMS
HVAC Systems
Cleanrooms – Aseptic
Air Locks – Gowning

LABORATORY EQUIPMENT
Incubators
CO2 Incubators
Water Bath Incubators
Ultra-Low Temperature Freezers
Refrigerators