Computer software validation

Figarole PL. Computer software validation techniques. DIA Conference on Computer Validation, Jan. 21-23, 1985. 

The ISO V model for system development life cycle in computer software validation is a structured description of such a process. In this instance, the basic V model has been adapted for analytical method validation and is shown in Figure 1. 

Lopez, Orlando. 21 CFR Part 11 complete guide to international computer validation compliance for the pharmaceutical industry/Orlando Lopez, p. cm. Includes bibliographical references and index. ISBN 0-8493-2243-X (alk. paper) 1. Pharmaceutical industry. 2. Computer software— Validation, 3. Computer programs—Verification. I. Title Twenty-one CFR Part Eleven. II. Title. RS192.L67 2004 338.4 76151-dc22 2003063460... 

SECTION A SECTION B SECTION C Computer Equipment Maintenance Logs Computer Software Validation and Verification Computerized Tracking Logs... 

QA SQPs should specify the amount of data to be audited and how the data points are chosen for audit. An auditor may choose to perform more thorough and more frequent audits on a recently validated system. The validation report can be used to assist in determining what and how much to audit. For example, if data summary printouts from the chromatographic computer system are used in the report, the validation report should be reviewed to verify that this summary function was tested during validation. If this portion of the computer software was successfully validated, verifying a few values from each table in the report may be sufficient. 

Many companies have developed or purchased computer software for the purpose of storing stability data for a large number of studies. Examples of commercially available systems are SLIM [147] and Stability System [148]. These systems can perform other functions as well, including work scheduling, preparation of summaries of selected or all studies in the system, tabulation of data for individual studies, label printing, statistical analysis and plotting, and search capabilities. Such systems should be validated to keep pace with current regulatory activity [149],... 

A number of computer software packages are available to the analyst to assist in the planning and execution of both method development and validation experiments. The attraction of these systems is that they can automate the validation process from planning the experiment to test execution to the presentation of the data in a final report form. 

As the pressure for the validation of analytical results to be validated increases, the computer software and the system have had to be modified so that they can operate in a hands-off fashion to a set protocol design. The Touchstone software provides this with the Program facility. Procedures and instruments can be changed within a single run. 

The main areas of application for more generalised models have, until recently, been restricted to binary and ternary systems or limited to ideal industrial materials where only major elements were included. The key to general application of CALPHAD methods in multi-component systems is the development of sound, validated thermodynamic databases which can be accessed by the computing software and, until recently, there has been a dearth of such databases. 

Validating computer software used to process and analyze a specimen. 

Nevertheless, in many electronic tongue studies, such constraints are ignored and ANNs are used as the default choice. This choice is also made in cases with very poor data sets and without performing a proper validation. This may be due to the fact that the related computational software is easily available and that many people have a propensity to follow the predominant trends and to use the most potent instruments available, without critical considerations. Furthermore, perhaps, there is a fashionable association of ideas coimecting the concepts of artificial tongue and artificial intelligence. 

A computer system is composed of software and hardware, equipment, a processor, and a user, and it is used to execute a specific procedure. Regardless of whether the computer system is developed in-house or by a contractor or purchased off the shelf, establishing documented end-user requirements is extremely important for computer systems validation. Without first establishing end-user needs and intended use, it is virtually impossible to confirm that the system can consistently meet them. Once established, it should obtain evidence that the computer system implements those needs correctly and that they are traceable to system design requirements and specifications. It is important that the end-user requirements specifications take into account predicate rules [12]. 

The U.S. Food and Drug Administration (FDA) has developed principles of software validation [3] and computer systems [4] used in an FDA 21 CFR Part 11-regulated environment. 

A computer systems validation program for regulated operations can be established based on the regulatory requirements, SQA practices, SQE practices, and type of software. 

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 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. 

Computer systems validation is an element of the SLC. In addition to the software and hardware testing, other verification activities include code walkthroughs, dynamic analysis, and trace analysis. 

The design specification describes, in a narrative and/or pictorial form, how the software will accomplish the software requirements and the interactions with the hardware to accomplish various functions of the device s design. 11 The most recent FDA validation guidance,12 which is exclusively applicable to medical devices, provides comprehensive information on the implementation of applicable software validation regulations to medical device computer systems performing regulated operations. 

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. 

All computer systems performing regulated operations must be validated. To support computer systems validation, operating systems and system software components are installed according to the manufacturer s instructions. The installation verification includes documentation gathered during the verification activities. 

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). 

When computers or automated data processing systems are used as part of production or the quality system, the manufacturer shall validate computer software for its intended use according to an established protocol. All software changes shall be validated before approval and issuance. These validation activities and results shall be documented. 

Computer systems validation personnel must also deal with design errors. A program that perfectly meets a lousy specification is a lousy program. Specifically for medical devices, books on software reliability tend to set aside the user interface issue, and treat it as the sole province of the human factor analyst. The reliability of a system is determined by how all its various parts, including the people who use it, work together. 

This Professional Edition of a pragmatic guide is designed to enlighten the industry at large, which suffers somewhat from the confusion created by earlier guidance documents now withdrawn. Written by an international expert in computer software and computer validation, it will become a classic of its kind when properly used to help companies implement their compliance requirements to meet the FDA and the MCA. 

Integration is a process of determining the area under a chromatographic peak for the quantitation of the analyte concentration. There are several scientifically valid techniques that may be used to integrate peaks. Modern chromatography computer software performs peak integration with a minimum of human intervention. Once an... 

This citation talks to a core concept of computer systems validation development procedures and system specifications. Note that the firm was not cited for lack of validation testing of the software but for lack of design controls. Effective design controls would have included written design procedures. Adherence to these procedures would have... 

Part 11 regarding validation of computer software and hardware. Any software used to operate process equipment, generate electronic records, track and transmit laboratory data, automate quality systems, operate critical utilities or software that is itself a medical device must be validated to ensure accuracy, reliability, consistency, and the ability to discern invalid or altered records. Where off-the-shelf software is used for any of the above cGMP activities, it must also be validated for its intended use. For additional information on compliance issues related to computer hardware and software validation refer to Chap. 7 of this book. 

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