Software Development Assurance

ANM-03-117-09, January 14, 2004. Policy Statement on Guidance for Determination of System, Hardware, and Software Development Assurance Levels on Transport Category Airplanes. FAA Memorandum. 

Ledinot, E., Astruc, J.M., Blanquart, J.R, Baufreton, R, et al. A cross-domain comparison of software development assurance standards. In Proceedings of the 6th Int. Conf. on Embedded Real Time Software and Systems, ERTS2 (2012)... 

This interim SoBP applies to the activities of contract assessment, software development, assurance, verification and validation and initial acceptance. It does not consider the in-service phase, nor does it consider in detail the concept and assessment phases. Nevertheless, many of the in-service issues are similar in scope to those presented here, especially considerations such as upgrading systems and die use of COTS products. It is the intent that further woik will be performed to provide guidance on through-life safety considerations, including operational safety. 

A decision not to perform the review (e.g., evidence that code is developed under a quality system and formal reviews have already been conducted and reported) should be documented in the project validation plan, complete with the rationale. It is recognized that under its software quality assurance program the supplier may conduct similar examination of the software using only internal resource. Considering GMP implications, the pharmaceutical manufacturer would normally require that the software designer or programmer does not carry out any software review in isolation. 

In many instances operating system software has already been developed and is offered as a fundamental part of the computer system ready for application software to be developed or configured. In such cases it is prudent to establish the existence of the respective software quality assurance plans and procedures and the design, development, and testing records. Identification and examination of this documentation can be conducted and recorded as part of the supplier audit. (See Sec. VI.)... 

The integrity of the information managed by a computer system is protected by procedural controls, rather than the technology used to apply the controls. Procedural controls comprise any measures taken to provide appropriate instructions for each aspect of system development, operations, calibration, and validation. For computer systems, procedural controls address all aspects of software engineering, software quality assurance, and operation. In a regulated environment, these controls are fundamental to the operation of the computer system. 

Human expertise in complex systems is constantly changing and a New Paradigm for software safety assurance is considered. As the development of Safety Critical Systems is guided by standards, the standards are to be updated3. In what follows we present a general view of how the development of safe software systems is currently practiced and show two specific solutions aimed at efficient support of the efforts. Responsibility of organizations, processes and culture, not just efforts of specific members of the organizations, is emphasized. 

The International Standards Organization (ISO) definition of audit is Systematic, independent, and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which agreed criteria are fulfilled. The bottom-line goal of the software developer audit process is to allow you to assess the developer s quality assurance (QA) system. 

History of company andproduct. Note that level of development staffing. Software development (SW Dev) and quality Assurance manual Describe purpose. For example, is it intended to facilitate validation by... 

This definition embraces all uses of computer systems and has been widely adopted, albeit with modifications, by the various GxP regulatory authorities around the world. These are sometimes dubbed computerized systems. The creation of validatable software is, in the first instance, largely a matter of the software developer adopting the basic principles of good software engineering practices under formal documented quality assurance supervision. 

This requirement is usually met by means of the audit conducted by the pharmaceutical or healthcare company. The audit examines the quality assurance attributes of the supplier s process, the firm s general capability maturity, and the suitability of its equipment or service suggested for use on the project. Suppliers in this context may be understood to include equipment vendors, service suppliers, or the pharmaceutical or healthcare company s in-house software development department. Regulators hold pharmaceutical and healthcare companies accountable for the use of suppliers whose capability assessment indicates their inability to deliver validatable, compliant software. ... 

Garston-Smith, H. (1997), Software Quality Assurance — A Guide for Developers and Auditors, ISBN 1-57491-049-3, Interpharm Press, Buffalo Grove, IL. 

The FDA will consider the lack of computer validation as a significant inspection finding and log it as a 483 noncompliance citation. The MHRA may take a more lenient view depending on the criticality of the system on GxP operations. The lack of a detailed written description of an individual computer system (kept up to date with controls over changes), its functions, security and interactions (EU GMP Annex 11.4) a lack of evidence for the quality assurance of the software-developed process (EU GMP Annex 11.5), coupled with a lack of adequate validation evidence to support the use of GxP-related computer systems may very well be either a critical or major deficiency. Ranking will depend on the inspector s risk assessment. 

The objective of vendor qualification is to get assurance that the vendor s products development and manufacturing practices meet the requirements of the user s firm. For software development this usually means that the software is developed and validated following documented procedures. The requirements usually vary between user firms and, within companies,... 

In parallel with these industrywide quality improvement efforts, the software industry had recognized the need to identify processes and standards that assured the quality of commercial software. ANSI (6) and IEEE (7) have been issuing practice standards and dehnitions for many years in an effort to unify quality assurance methodology in the software development industry. Furthermore, the software industry recognized early on that establishment of quality principles prior to the initiation of a development effort reduced the cost of repairing faulty software later in the process (8). 

Pre-shipment inspection can be performed along with vendor audits to address issues such as software development and quality assurance plans, operational reports, and specific vendor/purchaser inspection reports. 

Similarly, where a purchased source code is used or modified, the vendor s attention should be directed to AS3563. Vendors should be asked to provide written assurance that software development or modification has followed the quality management system of that Standard or of an equivalent system. 

A mechanism to provide some assurance that software development in the long term will not lead to operating difficulties as a result of uncoordinated standards and solutions could be beneficial. Options to approach this might be a more centralized management system, an agreed approach to standards setting, or other alternatives. Similarly, it could be beneficial if a formal as opposed to collegial approach to software development were implemented. 

Configuration/parameterization and new bespoke development of application software should be carried out in accordance with a software Quality Assurance System (see Figure 4.3). The diagram shows the following relationships ... 

Furthermore, it is also plain from the definition of validation above that documentary evidence is the lodestar of validation and the tool by which the assurance is derived. In respect of software, the assurance needed will be in the form of documentary evidence, not of the product directly (though this may be included) but, as we have shown, from an examination of the development process that produced it. This strongly implies that the product is inseparable from the process, and the fitness for use of the product can only be secured through the rigorous control of the process that produced it. This ought to come as no surprise, since it is precisely this principle, the essence of the science of statistical process control, that determines the quality of any manufactured or fabricated product. In other words, the quality (of fitness for use) of an item is entirely determined by the process that produced it, where quality is defined according to the ISO 8402 [3] ... 

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