JKS & Associates
Software Consulting
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JKS & Associates
Software Consulting
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Areas of ExpertiseDescription of ServicesSoftware development and software validation can be both laborious and confusing to those not experienced in the field or to those who are not familiar with the many current regulatory standards or guidance documents. We offer consulting assistance to help companies overcome these challenges. JKS & Associates has technical expertise in the following areas:
We offer full lifecycle software verification and validation assistance. This includes verification activities such as informal reviews, formal reviews, inspections and traceability. We can help potential clients write software requirements, system specifications, document the high level designs or software architectures, document the low level designs, review source code, and perform system validation. On the management side, we can write or provide tailored software development plans, software quality assurance plans, risk management plans, and software configuration management plans for your specific project. For critical or regulated products and processes we can perform risk, safety and hazard analyses using ISO 14971. We utilize Failure Modes and Effects analysis (FEMA) and Fault Tree Analysis (FTA) methods, if applicable. We can perform full system traceability using matrices from requirements to testing. The level of detail and amount of documentation is dictated by the risk of the device or process to humans and property. Examples of these activities and work products are available for review only during personal one on one interviewing.
In addition to the traditional project specific functional and physical configuration audits, we perform specialized software audits (both internal and external) that includes auditing against ISO 9001 for software organizations, 9000-3/TickIT using version 4/5 of the new TickIT reference information, ISO 12207 for lifecycle processes, AAMI SW 68 (Software Lifecycle Processes for Medical Device Software) , and ISO 15504 if applicable. We are also trained to perform Software Capability Evaluations (SCE) using version 3 of the SCE reference information against the Software Engineering Institute's (SEI) Software Capability Maturity Model (CMM), version 1.1. The SCE is useful in determining if a particular organization or supplier is skilled and capable to develop software for your company. For those who cannot afford a complete SCE, we offer a mini-SCE that is tailored to be performed in one to two days. This independent assessment method uses the CMM-based appraisal method and provides for a quicker assessment of a potential client's software development practices. We can also perform internal project audits of current development programs for your organization. For organizations that have a formal quality systems in place we can perform these internal audits, train individuals in audit/assessment skills, and lead your team through their first audit or assessment. We also perform software GMP auditing against the latest FDA GMP's for both diagnostic, clinical, biotech, pharmaceutical, medical device and computerized-manufacturing processes, systems and applications. We also can review your development activities and documentation for compliance against recent FDA software documents (i.e., Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, General Principles of Software Validation, Guidance for Off-the-Shelf Software Use in Medical Devices, Application of the Medical Device GMP To Computerized Devices and Manufacturing Processes, Computerized Systems Used in Clinical Trials, and 21 CFR Part 11 Electronic Records and Electronic Signatures).
We are experienced in setting up and managing software quality assurance (SQA) and testing organizations. For organizations that have a software quality assurance organization we can bring order and a consistent process to a less experienced group. This includes setting up and documenting SQA plans, SQA policies, SQA procedures, SQA audits and results, automated testing, defect tracking systems, configuration management systems, measuring the maturity of SQA groups and software quality metrics. Because of our experience and knowledge we can literally be a virtual quality assurance organization for your project or company. Samples of our work in these areas are available for review only during personal one-on-one interviewing.
By applying our knowledge and experience of software process improvement (SPI), we can provide clients with a number of services which include software process checks, defining, planning and executing of software process improvement directives and activities. We can also generate awareness, provide advice and assistance with SPI inside an organization or on a specific project and provide for independent assessments by a formally trained assessor. Where required, we can provide basic training in auditing and assessment skills, and provide basic introduction to several SPI models. These services can be tailored to meet the needs of a team, project or organization.
One of the most costly aspects of software development is software testing. With increasing customer demand for higher quality and more complex software, software testing is becoming a more important aspect of software development. In some organizations testing consumes 50% to 70% of the software development budget. The absence of well-planned and properly designed testing and monitoring can lead to significant schedule delays and high cost overruns. JKS & Associates can improve, tailor and simplify your test efforts to maximize the efficiency of your test process and reduce the cost of testing. We provide a number of scaleable software testing services which includes on-site and off-site consulting. This includes test planning, test project management, test approaches, improving test task completion, test development (specifying requirements, tools, resources, test tracking, test coverage analysis with test tools, test timing, and practices), producing and documenting test procedures, executing test cases, and documenting test results. If you do not have the resources to complete unit, integration, system, user acceptance or regression testing we can assist your organization in completing and documenting tests. We also provide project test auditing. Here, we perform intensive review(s) of current test project plans, test schedules, and test strategies to provide a independent assessment of the actual project. An audit report will be generated suggesting changes, contingencies or making improvements to the current test plans, strategies, and methods. This will insure that current test plans, strategies and methods will create the highest quality software with the least amount of effort.
Perhaps the most problematic area of software development is in the area of project
management. We provide a number of activities that include:
We also provide general consulting in software requirements analysis and design, IEC 601-1-4, CE for medical devices, Medical Device Directive (MDD), software metrics, software measurement, and documenting various software lifecycle activities. We have also provided general consulting in complying with the FDA Good Manufacturing Practices (GMP’s) especially with computer-controlled devices and manufacturing processes. We also provide assistance in 21 CFR Part 11, Electronic Records and Electronic Signatures. To assist small and medium-sized medical device and medical manufacturing companies we provide assistance in documenting Standard Operating Procedures (SOP's), design qualifications (DQ), installation qualifications (IQ), performance qualifications (PQ), and operational qualifications(OQ).
We can provide brief and specialized software education and training in the form of mini-tutorials, introductions and presentations for our clients. Most of these presentations and tutorials are about 1 to 2 hours in duration. Previous training topics given include "Introduction to the "SEI CMM," "Software Quality Assurance," and the "Year 2000 Issue."
We can provide expertise in performing and facilitating project retrospectives. A retrospective is the formal process of looking back over a project. It allows individuals, teams, projects, and management the ability to focus on what was important, and helps them acknowledge significant events or accomplishments during a project. It also allows them to examine mistakes so that they can learn from them. The retrospective can be both qualitative and quantitative based on the needs of the organization. The time for a retrospective can be tailored based on the team, project and organization. Typical time frames for these events can be as short as half of a day onsite to three days offsite.
The software literature is filled with stories of the importance of developing people who are part of a cohesive, goal-oriented team. One way to achieve such a high performance team is to make sure that every team involved in the development process has gone through some type of team building exercise. We can provide expertise in performing and facilitating software and or development team building exercises for new projects, newly formed teams, existing teams, virtual teams, low performing teams, new departments, or organizations. The team building exercises can range from simple exercises that takes a few minutes to complete to sophisticated experiential training exercises that can run an entire day. In addition we are also licensed by CPP, Inc. to administer the Myers Briggs Type Indicator (MBTI®) Step 1 instrument. This instrument can provide insight into the role that personality type plays within individuals and within teams. The MBTI® instrument can specifically identify personal strengths and weaknesses, other team member's strengths weaknesses, a team's overall strengths and weaknesses, and an organization's overall strengths and weaknesses. This tool can be a part of a team building exercise or program or can be part of a separate organizational development program for individuals and teams. The MBTI® workshop is generally run over two separate days (of about 2 hours each day) so the instruments can be scored after the preliminary information about MBTI® is provided to the participants. We can also provide examination of behavior and values based on Keirsey's Temperament sorter and an examination of Interaction Styles as part of a team building exercise. Each instrument can provide insight into individual personality type and behavior as well as team dynamics and team behavior. In summary, we provide a number of full life cycle consulting services when :
© 1998-2004 by John Suzuki
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