Abstract: In the last decade or so, Agile software development methods have proven their worth in a variety of industry settings, delivering faster time to market, increased productivity, higher quality, and improved morale and motivation. Traditionally, however, these methods have not been applied to high assurance and regulated environments: those industries where the economic or human cost of errors is unacceptably high. There, enterprises have relied primarily on sequential, stage-gated, waterfall methods, often meeting verification and validation requirements via burdensome documentation and labor intensive, and potentially error-prone, manual processes. However, many such enterprises have concluded that in order to achieve the next level of product quality and safety improvements, not to mention enhanced competitiveness, adoption of a more Agile approach is required. In this whitepaper, the author describes an Agile software development approach for high assurance systems that addresses many of the challenges found in these environments.
A validation plan describes the approach and responsible parties for validating a system within its operating environment. The "system" could be a piece of manufacturing equipment, a manufacturing process, or a computerized system. The key elements of a validation plan include: *The scope of work - the Validation Plan identifies both the system and its component elements to be validated and the required documentation *The responsibilities - the Validation Plan identifies the roles and specific responsibilities of the parties responsible for validating the system *The approach - the Validation Plan outlines the strategy for validating the system within its operating environment. The approach is generally bounded by the standards, procedures, and methodologies of the executing organization.
A Validation Plan is required whenever significant changes are made to facilities, equipment or processes affect the quality of a product.
Adding a little bit of structure into one's affairs never hurts, especially when it comes to IT business processes and assets. To this end, various frameworks offer blueprints for achieving key organizational objectives like compliance and security. Three of the more popular frameworks—COBIT, ITIL, and TOGAF—are widely used by enterprises in this regard—let's see how they compare when it comes to bolstering cybersecurity and digital resilience.
Verification and validation – These are the two important aspects of software quality management. Verification gives the answer to the question whether the software is being developed in a correct way and validation provides the answer whether the right software is being produced. In a nutshell, verification denotes precision whereas validation indicates value of the end or final product. Verification and validation is an important step used in various processes in different industries.
Importance of Validation Validation is requisite in the quality management process. It makes sure that the process or product meets the purpose intended. There are different categories of validation in general described below-
Prospective Validation This type of validation is done to ensure the characteristics of interest before the product gets launched. Proper functioning of the product meeting the safety standards is also checked in the process of validation.
• 1987: Process validation is establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality characteristics
• 2008: Process validation is defined as the collection and evaluation of data, from the process design stage throughout production, which establishes scientific evidence that a process is capable of consistently delivering quality products.
Artiﬁcial Intelligence (AI) is no longer some bleeding technology that is hyped by its proponents and mistrusted by the mainstream. In the 21st century, AI is not necessarily amazing. Rather, it is often routine. Evidence for the routine and dependable nature of AI technology is everywhere (see the list of applications in ). AI approach has always been at the forefront of computer science research. Many hard tasks were ﬁrst tackled and solved by AI researchers before they transitioned to standard practice. Those examples include time-sharing operating systems, automatic garbage collection, distributed processing, automatic programming, agent systems, reﬂective programming and object-oriented programming.
To stay competitive in a digital economy, businesses increasingly need to move beyond simple reporting and descriptive analytics to a more predictive approach that puts artificial intelligence (AI) strategies to work to engage with customers in new ways. So how can you find a practical way to start applying AI in your business? One path forward follows three steps: leverage predictive models to improve how you engage with customers, put machine learning to work to improve those models, and then validate your models. In an earlier blog, I explored the dynamics of predictive analytics and machine learning. In this post, I will focus on the validation of predictive models First let me provide a quick overview of predictive analytics and machine learning, and explain why validation is important when you apply these approaches.
It is predicted that robots will replace many jobs in next 30 years time. However, one of the first critical roles they need to replace is the verification and validation of data input from human error. This is one of most common problems that occurs in business where human error can cause fraud not to mention decline someone from an application that they may have made for a mortgage, loan, security clearance, or recruitment. Furthermore, a business requires data entry in supply chain, ledger accounting, and more.
Two forms of Health Check are offered the Silver Appraisal (SCAMPI B) and Gold Appraisal (SCAMPI A).
Both are led by a Certified CMMI® Lead Appraiser supported by trained Appraisal Team Members.
The primary difference between the two types of Health Check is the level of rigor and the fact that the SCAMPI A Appraisal can provide a Capability Level for each of the PMO Process Area in scope, the results can also be published on the CMMI® Institute PARS Site (Published Appraisal Results) if required.
The key deliverable being a report highlighting strengths and opportunities for improvement. This can optionally be expanded into a comprehensive PMO Improvement Plan the implementation of which can be supported by DEMIX Consultants if required.
If your PMO is not adding the value you expected then perform a DEMIX PMO Health Check to find out why!
To find out more or register interest contact Stephen Woods via the email below: