study after research study shows that requirements errors are the number one cause of software project failures (costing U. companies approximately billion a year in total1), many organizations continue to deliver requirements that are unclear, ambiguous or incomplete.
These erroneous requirements then go on to be tracked, traced and perfectly executed, resulting in a system that "does what was required" but unfortunately doesn't do what business users thought they asked for.
The actual CFR 21 Part 11 and CFR 21 Part 820 regulations focus specific requirements that may seem to be only somewhat related to software development.
For instance, CFR 21 Part 11 defines the requirements for a digital signature and electronic record to be considered valid, whereas CFR 21 Part 820 governs the quality of medical devices.
The body of best practices associated with software testing is comprehensive -- there's even an ISO standard associated with software evaluation.
In contrast, requirements testing is often carried out in an ad-hoc manner, using outdated or impractical methods that leave a lot of room for error and miscommunication. Following are some key "best practices" for ensuring that requirements are as complete and accurate as possible, at all stages of development: Know where your problem is The requirements development lifecycle consists of several important, yet different processes -- elicitation (gathering requirements), specification and analysis (putting requirements into a formal model or document, such as a use case, and inviting stakeholder feedback) and validation (making sure everyone understands and agrees on the requirements put forth, and that they are realistic and precise).
I am trying to understand the difference a little better as it seem like they are the same thing.
I have work in projects with no use of the requirements and everything is an acceptance criteria, and on projects that have both.
Anyway, not only I reworded it, I added additional information.Microsoft Press defines Acceptance Criteria as “Conditions that a software product must satisfy to be accepted by a user, customer or other stakeholder.” Google defines them as “Pre-established standards or requirements a product or project must meet.” Acceptance Criteria are a set of statements, each with a clear pass/fail result, that specify both functional (e.g., minimal marketable functionality) and non-functional (e.g., minimal quality) requirements applicable at the current stage of project integration.These requirements represent “conditions of satisfaction.” There is no partial acceptance: either a criterion is met or it is not.Northwest Cadence June 2011This white paper focuses on the initial chapter of Title 21 of the Code of Federal Regulations (referred to simply as CFR 21), which governs food and drugs that are manufactured in the United States.The other chapters of CFR 21, which cover the Drug Enforcement Agency (DEA) and the Office of National Drug Control Policy (ONDCP), are outside the scope of this white paper.