Computer systems validation process

The depth and scope of the validation depends on the category of the software, and the complexity and criticality of the application. Refer to Chapter 7 for details of the computer system validation process. 

The elements to be included as part of the computer systems validation process will vary depending on the category of the software. It is the practice in the FDA-regulated industry to take into account five (5) categories of software. 

Qualification is the process of demonstrating whether a computer system and its associated controlled process/operation, procedural controls, and documentation are capable of fulfilling the specified requirements. Sidebar 10-11 depicts the context of the qualification activities and the computer systems validation process. The physical components of the systems are reviewed and its specific elements, subunits, and parameters are documented. A qualification also serves to verify and document the acceptability of the design, implementation, integration, and installation of the computer system components. The execution of the qualification is the mechanism by which documented evidence is created that verifies that the computer system performs according to its predetermined specification. 

Laboratories using computer technology must assure that they have adequate controls in their delivery of data to the EPA. Computer system validation is the process by which a computer system is shown to consistently do what it is supposed to do and only what it is supposed to do. In effect, the validation study confirms and documents the areas of control and the specifications contained in the GALP requirements. 

October 23, 2002 Process Analytical Technology Subcommittee Meeting o Computer systems validation—Part 11 issues pertinent to PAT... 

Equipment qualification covers the entire life of a product. It starts when somebody has an idea about a product and ends when the equipment is retired. For computer systems validation, this ends when all records on the computer system have been migrated and validated for accuracy and completeness on a new system. Because of the length of time and complexity, the process has been broken down into shorter phases design qualification (DQ), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) [2]. The process is illustrated in Figure 17.1. 

The most important factors for the entire process of equipment qualification and computer system validation in analytical laboratories are proper planning, execution of qualification according to the plan, and documentation of the results. The process should start with the definition of the analytical technique and the development of user requirement and functional specifications. For computer systems, a formal vendor assessment should be made. This can be done through checklists and vendor documentation with internal and/or external references. For very complex systems, it should go through a vendor audit. 

Whether a control system comprises distinct instruments for nominal control functions and process monitoring, or an integrated control system, a nominal set of control function tests are necessary. The tests described encompass both controller capability and equipment performance. These tests may be completed during the FAT as part of a separate computer system validation. 

Computer System Validation Controlling the Manufacturing Process... 

Whatever the validation approach, the fundamental requirement for computer system validation is to establish documented evidence that provides a high degree of assurance that the system consistently operates in accordance with predetermined specifications. The EC guide to GMP also requires periodic critical revalidation to be considered to ensure processes and procedures remain capable of achieving the intended results. 

All projects have a life of their own and each person has a different methodology and timing for getting the job done. Success in computer systems validation will depend on the operating committee s ability to keep the process moving. One means of project control is a tracking format that identifies the key steps in the validation process and the anticipated and actual completion dates. 

Steering Committee/Operating Committee monitoring of the administrative process for computer systems validation. 

The validation of computer systems is an exercise in project management. The fact that computers are involved does not mean that the approach will be significantly different. It does mean that the responsible users will be the focal point of computer systems validation they will have to assume the responsibility for validation of the computer systems they use just as they are responsible for all other compliance aspects of their operation. MIS will play a key role since their computer expertise and interface with the suppliers is required throughout the process. 

The development model associated with the SLC contains the software engineering tasks and associated work products necessary to support the computer system validation effort. It breaks the systems development process down into sub-periods during which discrete work products are developed. This approach leads to well-documented systems that are easier to test and maintain, and for which an organization can have confidence that the system s functions will be fulfilled with a minimum of unforeseen problems. 

During the implementation or update process, the introduction of a computer validation management cycle will provide a top-down approach to integrate computer systems validation strategies in order to support the project. Figure 5-1 suggests a computer validation management cycle. 

The Computer Systems Validation (CSV) Executive Committee is composed of Validation, Compliance, Regulatory Affairs, and Information Technology senior management. Another possible member of this committee is a Process Innovator. 

Each phase of the SLC must be controlled to maximize the probability that a finished system meets all quality, regulatory, safety, and specification requirements. If an SLC approach is applied properly, no additional work will be required to validate a system. For each SLC period and event, computer systems validation requires that the development processes are documented work products. As explained in Chapter 2, phase gate verification activities performed during each event may be a perfect place to review and quantify the quality of all products needed to support the next phase. 

The quality attributes applicable to all procedural controls are that they are appropriate, clear, and consistent with related procedures, adhere to regulatory, industry, and company standards, and are approved, available, accessible, followed, controlled, and periodically reviewed. The SLC process must be consistent with the applicable computer systems validation procedural controls. 

Computer Systems Validation (CSV) The formal assessment and reporting of quality and performance measures for all the life-cycle stages of software and system development, its implementation, qualification and acceptance, operation, modification, requalification, maintenance, and retirement, such that the user has a high level of confidence in the integrity of both the processes executed within the controlling computer system(s), and in those processes controlled by and/or linked to the computer system(s), within the prescribed operating environments) (MCA). 

An inventory of systems and knowledge, of which one is GMP-critical, must be maintained and available for inspections. An MHRA preinspection checklist has this as one of its opening topics. The availability or otherwise of this information is a clear indicator of whether management is in control of its computer systems validation. The use of an inventory need not be limited to inspection readiness it could also be used for determining supplier audits and periodic reviews, etc. Many pharmaceutical and healthcare companies use a spreadsheet or database to maintain this data. Where a site s inventory is managed between a number of such applications (perhaps one per laboratory, one for process control systems, one for IT systems), care must be taken that duplicate entries are avoided and, equally, that some systems are missed and not listed anywhere. It should be borne in mind that where spreadsheets and databases are used to manage an inventory, it should be validated just like any other GxP computer application. 

Some compaiues would not include CHAZOP as part of the computer system validation. However, the CHAZOP process can provide a formal mechanism for reviewing and assessing a system design. 

Computer systems validation (CSV) is an ongoing process that involves the evaluation and documentation of... 

---