| "Establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specification and quality attributes" .. FDA description of validation | |
| Introduction | |
| The Validation Plan | |
| Validation of automated systems | |
Some manufacturing processes, particularly in the pharmaceutical industry, require licensing by a regulatory authority such as the Food and Drugs Administration (FDA) in the US or the Medicines Certification Authority (MCA) in the UK. Before a licence is granted, a validation procedure must have been completed. This procedure may cover buildings, equipment, processes, cleaning etc. The validation of an automated control system is one element of this complete procedure.
In the last few years, licensing authorities have started to focus more than ever upon the role played by automated systems within the overall manufacturing process. It is increasingly important that systems intended for use in regulated environments are specified, designed, tested, and put to work using methodologies that will satisfy the scrutiny of the relevant inspectors.
Although validation is the responsibility of the user, it is imperative that they and the vendor work closely together at all stages if validation is to be smoothly achieved.
This document outlines Nova Weigh’s policy concerning projects which will require validation.
Nova Weigh has selected the ‘Life Cycle’ model as the best, and most cost-effective, route to achieving a fully validated automated system.
The Life Cycle approach starts with the identification of the user’s requirements and finishes only when the system is finally taken out of service. Defined steps in the cycle include design, integration, putting to work and maintenance.
It is most important that validation is incorporated into each stage of the cycle and not considered as a separate issue.
Modular approach
Nova Weigh’s philosophy is to consider an automated system as a series of modules; many of which are common to several projects. In addition there may be customised elements to match specific user needs. Typical modules are ..
The validation ‘package’ is tailored to the type of module. An advantage of this philosophy is that the supporting documentation is standardised with consequential efficiency benefits.
The validation process is controlled by a Validation Plan which is produced by the user.
This plan will typically require the creation of a number of protocols. Their purpose is to establish a structured series of formal checks that each stage of the validation process has been properly completed.
The protocols that are relevant here are ..
.. these terms are defined in the attached glossary
Nova Weigh operates an ISO 9001 accredited Quality System which ensures that the design of any automated system is fully documented and the procedures relate well to the validation process and Nova Weigh’s involvement in these protocols.
Nova Weigh’s involvement
Once Nova Weigh has been appointed the supplier, then it will become involved in the Pre-qualification or Specification Qualification stage. Nova Weigh will produce a Functional Specification and, in conjunction with the user, an Acceptance Test specification. The Functional Specification will describe the system architecture and the method of achieving the functionality of the Requirement Specification.
After approval by the customer, a Design Specification will be produced for both the hardware and software. This will include, diagrams showing the relationship between the functional parts of the system and the inputs, outputs and processes.
The hardware will be described by reference to product data sheets where appropriate to cover such items as the central processing unit, the man-machine interfaces, I/O modules, network modules and cabling, peripheral devices and instruments.
The software will be treated according to type. The operating and configurable software, which does not change from user to user, will be described by reference to product data sheets etc. The application software, which is unique to the process or user application, will be provided with program structure charts, function charts, man machine interface screens, report formats, alarm configurations, and PLC logic functions.
Once the system is completed, the design will be frozen and any changes will be subject to formal design control procedures.
The system will be tested in accordance with the test plan and presented for acceptance testing in accordance with the acceptance test specification. Documentation of these test results will be supplied as part of the documentation package.
The system must then be installed and calibrated. Nova Weigh is able to provide traceable calibrations for all the weighing equipment.
The Installation Qualification phase requires a documentation package to be produced for the system. For the computer or PLC equipment, Nova Weigh will provide, design drawings, I/O allocation tables, PLC logic listings, operating instructions and user manuals. Mechanical elements such as LoadMount assemblies or weigh scales will be supplied with dimensional drawings and installation specifications. The only part of the IQ that pertains to software is confirmation that the correct software issues have been loaded onto the hardware.
The Operation Qualification phase will involve the testing of the full system although some of the tests may also form part of the acceptance test of the software. A series of challenging tests should be performed so as to confirm the correct and predicable operation of the system. These tests may include PID loop tuning, emergency power systems, alarm points, valve or motor actuation, communications, security, input ranges, interlocks and timers.
The ‘Life Cycle’ Model for validation
A Summary of the typical Documentation Requirements for a Weighing/Control System requiring validation - document names and content may vary according to the project scope and client’s requirements
| Document | Function and Content | By | |
| 1 | Validation Plan | A project specific plan which describes the overall approach and refers to client’s established validation procedures. It is likely to include; brief system overview, project organisation, timing, project responsibilities and documentation requirements. | Client |
| 2 | User Requirement Specification (URS) | This describes the system from the point of view of the user. It should describe e.g., the operator interface, inputs, outputs, control algorithms, calculations and reports. | Client |
| 3 | Project Quality Plan | A description of the quality procedures that will be adopted during the implementation of the project. This will reference the relevant parts of the Nova Weigh ISO 9001 quality system. | Nova Weigh |
| 4 | Functional Design Specification (FDS) | A description from the designers point of view. This is derived from the URS and will contain sufficient information to form a basis for the writing of the application software. | Nova Weigh |
| 5 | Test Specification | This will form a basis for the works testing for the system prior to shipping but may also form a part of the Operational Protocol. It will include the prerequisites for testing, test actions (covering both normal and abnormal situations) with the required outcomes. Forms will be included to record the outcomes. | Nova Weigh |
| 6 | Installation Protocol | The plan describing how the installation qualification will be performed. (note .. Nova Weigh’s scope of supply may include some drawings and documentation to support this. Examples could include electrical installation hook-ups, installation instructions, calibration procedures. The methods of calibration for weighing equipment could also be described here) | Client with input from Nova Weigh |
| 7 | Operational Protocol | The plan describing how the operation qualification will be performed. | Client |
| 8 | Performance Protocol | The plan describing how the performance qualification will be performed. | Client |
| 10 | Validation Report | A comprehensive summary which explains how the requirements of the Validation Plan have been met. This document will include signatures required to approve the taking of the system into production. | Client |
| 11 | Change Control Documents | Define the methodology adopted to carry out and record any changes made to the validated system. | Client |
Glossary of terms as used in this document
| Term and Definition | Comment |
| Validation Plan: A plan created by the customer to define validation activities, responsibilities and procedures. | This will be reflected in the Nova Weigh Quality Plan |
| Specification Qualification (SQ): A documented evaluation of the detailed specification, carried out for the purpose of confirming compliance with the User Requirement and Functional Specification and providing the detailed design documentation required for subsequent stages of validation (e.g. Installation and Operational Qualification) and ongoing operation of the facility or system in compliance with regulatory requirements related to product quality. | The customer will normally generate a User’s Requirement Specification which will form a basis for Nova Weigh’s Functional Design Specification. |
| † Installation Qualification (IQ): Documented verification that all key aspects of hardware installation adhere to appropriate codes and approved design intentions and that the recommendations of the manufacturer have been suitably considered. | Supported by Nova Weigh providing documentation package and records of Factory Acceptance Testing. Site engineering assistance is available for the proper installation and calibration of, e.g. vessel weighing systems and scales. |
| † Operation Qualification (OQ): Documented verification that the equipment-related system or sub-system performs as intended throughout representative or anticipated operating ranges. | Nova Weigh engineers can assist, if requested, with the Site Acceptance Testing of the automated system. |
| † Performance Qualification (PQ): Documented verification that the process and/or the total process-related system performs as intended throughout all anticipated operating ranges. | Generally performed by the user’s production and validation staff. PQ differs from the OQ since its purpose is to demonstrate that the control system, instruments and plant operate correctly together. |
Note that terms marked (†) are in accordance with PMA definitions from the Pharmaceutical Technology Conference, 1991. Other definitions are taken from the document ‘Pharmaceutical Industry Supplier Guidance - Validation of Automated Systems in Pharmaceutical Manufacture’ published by the UK Pharmaceutical Industry Computer Systems Validation Forum.
The purpose of this document is to provide an outline of Nova Weigh’s policy regarding validation and it is not intended as an authoritative statement of the regulatory requirements. We will be pleased to discuss a specific project and assist in the preparation of a validation strategy tailored to suit.
p4020, 17 April 1998