CONTEXT FOR SOFTWARE VALIDATION

Many people have asked for specific guidance on what FDA expects them to do to ensure compliance with the Quality System regulation with regard to software validation.

Due to the great variety of medical devices, processes, and manufacturing facilities, it is not possible to state in one document all of the specific validation elements that are applicable. However, a general application of several broad concepts can be used successfully as guidance for software validation. These broad concepts provide an acceptable framework for building a comprehensive approach to software validation.

3.1. DEFINITIONS AND TERMINOLOGY

Unless defined in the Quality System regulation, or otherwise specified below, all other terms used in this guidance are as defined in the current edition of the FDA Glossary of Computerized System and Software Development Terminology.

The medical device Quality System regulation (21 CFR 820.3(k)) defines "establish" to mean "define, document, and implement." Where it appears in this guidance, the words "establish" and "established" should be interpreted to have this same meaning.

Some definitions found in the medical device Quality System regulation can be confusing when compared to commonly used terminology in the software industry. Examples are requirements, specification, verification, and validation.

3.1.1 Requirements and Specifications

While the Quality System regulation states that design input requirements must be documented, and that specified requirements must be verified, the regulation does not further clarify the distinction between the terms "requirement" and "specification." A requirement can be any need or expectation for a system or for its software. Requirements reflect the stated or implied needs of the customer, and may be market-based, contractual, or statutory, as well as an organization's internal requirements. There can be many different kinds of requirements (e.g., design, functional, implementation, interface, performance, or physical requirements). Software requirements are typically derived from the system requirements for those aspects of system functionality that have been allocated to software. Software requirements are typically stated in functional terms and are defined, refined, and updated as a development project progresses. Success in accurately and completely documenting software requirements is a crucial factor in successful validation of the resulting software.

A specification is defined as "a document that states requirements." (See 21 CFR §820.3(y).) It may refer to or include drawings, patterns, or other relevant documents and usually indicates the means and the criteria whereby conformity with the requirement can be checked. There are many different kinds of written specifications, e.g., system requirements specification, software requirements specification, software design specification, software test specification, software integration specification, etc. All of these documents establish "specified requirements" and are design outputs for which various forms of verification are necessary.

3.1.2 Verification and Validation

The Quality System regulation is harmonized with ISO 8402:1994, which treats "verification" and "validation" as separate and distinct terms. On the other hand, many software engineering journal articles and textbooks use the terms "verification" and "validation" interchangeably, or in some cases refer to software "verification, validation, and testing (VV&T)" as if it is a single concept, with no distinction among the three terms.

Software verification provides objective evidence that the design outputs of a particular phase of the software development life cycle meet all of the specified requirements for that phase. Software verification looks for consistency, completeness, and correctness of the software and its supporting documentation, as it is being developed, and provides support for a subsequent conclusion that software is validated. Software testing is one of many verification activities intended to confirm that software development output meets its input requirements. Other verification activities include various static and dynamic analyses, code and document inspections, walkthroughs, and other techniques.

Software validation is a part of the design validation for a finished device, but is not separately defined in the Quality System regulation. For purposes of this guidance, FDA considers software validation to be "confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled." In practice, software validation activities may occur both during, as well as at the end of the software development life cycle to ensure that all requirements have been fulfilled. Since software is usually part of a larger hardware system, the validation of software typically includes evidence that all software requirements have been implemented correctly and completely and are traceable to system requirements. A conclusion that software is validated is highly dependent upon comprehensive software testing, inspections, analyses, and other verification tasks performed at each stage of the software development life cycle. Testing of device software functionality in a simulated use environment, and user site testing are typically included as components of an overall design validation program for a software automated device.

Software verification and validation are difficult because a developer cannot test forever, and it is hard to know how much evidence is enough. In large measure, software validation is a matter of developing a "level of confidence" that the device meets all requirements and user expectations for the software automated functions and features of the device. Measures such as defects found in specifications documents, estimates of defects remaining, testing coverage, and other techniques are all used to develop an acceptable level of confidence before shipping the product. The level of confidence, and therefore the level of software validation, verification, and testing effort needed, will vary depending upon the safety risk (hazard) posed by the automated functions of the device. Additional guidance regarding safety risk management for software may be found in Section 4 of FDA's Guidance for the Content of Pre-market Submissions for Software Contained in Medical Devices, and in the international standards ISO/IEC 14971-1 and IEC 60601-1-4 .

3.1.3 IQ/OQ/PQ

For many years, both FDA and regulated industry have attempted to understand and define software validation within the context of process validation terminology. For example, industry documents and other FDA validation guidance sometimes describe user site software validation in terms of installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ). Definitions of these terms and additional information regarding IQ/OQ/PQ may be found in FDA's Guideline on General Principles of Process Validation, dated May 11, 1987,.

While IQ/OQ/PQ terminology has served its purpose well and is one of many legitimate ways to organize software validation tasks at the user site, this terminology may not be well understood among many software professionals, and it is not used elsewhere in this document. However, both FDA personnel and device manufacturers need to be aware of these differences in terminology as they ask for and provide information regarding software validation.

3.2. SOFTWARE DEVELOPMENT AS PART OF SYSTEM DESIGN

The decision to implement system functionality using software is one that is typically made during system design. Software requirements are typically derived from the overall system requirements and design for those aspects in the system that are to be implemented using software. There are user needs and intended uses for a finished device, but users typically do not specify whether those requirements are to be met by hardware, software, or some combination of both. Therefore, software validation must be considered within the context of the overall design validation for the system.

A documented requirements specification represents the user's needs and intended uses from which the product is developed. A primary goal of software validation is to then demonstrate that all completed software products comply with all documented software and system requirements. The correctness and completeness of both the system requirements and the software requirements should be addressed as part of the design validation process for the device. Software validation includes confirmation of conformance to all software specifications and confirmation that all software requirements are traceable to the system specifications. Confirmation is an important part of the overall design validation to ensure that all aspects of the medical device conform to user needs and intended uses.

3.3. SOFTWARE IS DIFFERENT FROM HARDWARE

While software shares many of the same engineering tasks as hardware, it has some very important differences. For example:

• The vast majority of software problems are traceable to errors made during the design and development process. While the quality of a hardware product is highly dependent on design, development and manufacture, the quality of a software product is dependent primarily on design and development with a minimum concern for software manufacture. Software manufacturing consists of reproduction that can be easily verified. It is not difficult to manufacture thousands of program copies that function exactly the same as the original; the difficulty comes in getting the original program to meet all specifications.One of the most significant features of software is branching, i.e., the ability to execute alternative series of commands, based on differing inputs. This feature is a major contributing factor for another characteristic of software - its complexity. Even short programs can be very complex and difficult to fully understand.
• Typically, testing alone cannot fully verify that software is complete and correct. In addition to testing, other verification techniques and a structured and documented development process should be combined to ensure a comprehensive validation approach.
• Unlike hardware, software is not a physical entity and does not wear out. In fact, software may improve with age, as latent defects are discovered and removed. However, as software is constantly updated and changed, such improvements are sometimes countered by new defects introduced into the software during the change.
• Unlike some hardware failures, software failures occur without advanced warning. The software's branching that allows it to follow differing paths during execution, may hide some latent defects until long after a software product has been introduced into the marketplace.
• Another related characteristic of software is the speed and ease with which it can be changed. This factor can cause both software and non-software professionals to believe that software problems can be corrected easily. Combined with a lack of understanding of software, it can lead managers to believe that tightly controlled engineering is not needed as much for software as it is for hardware. In fact, the opposite is true. Because of its complexity, the development process for software should be even more tightly controlled than for hardware, in order to prevent problems that cannot be easily detected later in the development process.
• Seemingly insignificant changes in software code can create unexpected and very significant problems elsewhere in the software program. The software development process should be sufficiently well planned, controlled, and documented to detect and correct unexpected results from software changes.
• Given the high demand for software professionals and the highly mobile workforce, the software personnel who make maintenance changes to software may not have been involved in the original software development. Therefore, accurate and thorough documentation is essential.
• Historically, software components have not been as frequently standardized and interchangeable as hardware components. However, medical device software developers are beginning to use component-based development tools and techniques. Object-oriented methodologies and the use of off-the-shelf software components hold promise for faster and less expensive software development. However, component-based approaches require very careful attention during integration. Prior to integration, time is needed to fully define and develop reusable software code and to fully understand the behavior of off-the-shelf components.

For these and other reasons, software engineering needs an even greater level of managerial scrutiny and control than does hardware engineering.

3.4. BENEFITS OF SOFTWARE VALIDATION

Software validation is a critical tool used to assure the quality of device software and software automated operations. Software validation can increase the usability and reliability of the device, resulting in decreased failure rates, fewer recalls and corrective actions, less risk to patients and users, and reduced liability to device manufacturers. Software validation can also reduce long term costs by making it easier and less costly to reliably modify software and revalidate software changes. Software maintenance can represent a very large percentage of the total cost of software over its entire life cycle. An established comprehensive software validation process helps to reduce the long-term cost of software by reducing the cost of validation for each subsequent release of the software.

3.5 DESIGN REVIEW

Design reviews are documented, comprehensive, and systematic examinations of a design to evaluate the adequacy of the design requirements, to evaluate the capability of the design to meet these requirements, and to identify problems. While there may be many informal technical reviews that occur within the development team during a software project, a formal design review is more structured and includes participation from others outside the development team. Formal design reviews may reference or include results from other formal and informal reviews. Design reviews may be conducted separately for the software, after the software is integrated with the hardware into the system, or both. Design reviews should include examination of development plans, requirements specifications, design specifications, testing plans and procedures, all other documents and activities associated with the project, verification results from each stage of the defined life cycle, and validation results for the overall device.

Design review is a primary tool for managing and evaluating development projects. For example, formal design reviews allow management to confirm that all goals defined in the software validation plan have been achieved. The Quality System regulation requires that at least one formal design review be conducted during the device design process. However, it is recommended that multiple design reviews be conducted (e.g., at the end of each software life cycle activity, in preparation for proceeding to the next activity). Formal design review is especially important at or near the end of the requirements activity, before major resources have been committed to specific design solutions. Problems found at this point can be resolved more easily, save time and money, and reduce the likelihood of missing a critical issue.

Answers to some key questions should be documented during formal design reviews. These include:

• Have the appropriate tasks and expected results, outputs, or products been established for each software life cycle activity?
• Do the tasks and expected results, outputs, or products of each software life cycle activity:
  • Comply with the requirements of other software life cycle activities in terms of correctness, completeness, consistency, and accuracy?
  • Satisfy the standards, practices, and conventions of that activity?
  • Establish a proper basis for initiating tasks for the next software life cycle activity?
  • Ref:https://www.fda.gov