The AAMI TIR 45 is invaluable in helping adapt Agile methods for medical device software

A report from the Association for the Advancement of Medical Instrumentation, namely, AAMI TIR 45, offers recommendations for how to comply with both international standards and guidance documents from the FDA when it comes to Agile practices for developing medical device software.

The AAMI TIR 45 is an attempt to align and synchronize Agile’s values, goals, principles and practices to medical device software development. It shows the ways of doing this. It seeks to remove the many misconceptions and myths surrounding the suitability and adaptability of Agile to medical device software and explains how to apply Agile methods for meeting the Quality System requirements set out for medical device software.

AAMI TIR 45 has been set out to help manufacturers of medical device software reap the benefits that Agile provides, while staying compliant with the regulatory expectations and requirements.

The AAMI TIR 45 was created because of the value that Agile can bring to medical device software. One of the reasons for which Agile was developed was to address concerns relating to the quality and efficiency present in the methods of software development that existed then. When its core features are adapted to the medical device software field, it brings enormous benefits, some of which include:

–       It allows for continuous and persistent focus on risk management, safety and delivering customer value through its method of prioritizing backlog work, and practices relating to planning and customer feedback

–       It uses continuous integration and testing to continuously and consistently assess quality

–       Through its methods of retrospective action and accountability; Agile brings in continuous improvement into the process of software development

–       By focusing on getting things done one stage at a time and thus ensuring timely and incremental completion of work and deliverables; Agile satisfies the demands and needs of the medical device company’s stakeholders in the management and quality areas.

A few reservations

Many experts in both medical device software and Agile fields have expressed reservations about the suitability that Agile has in an extremely stringently regulated area such as medical device software. They refer to the Agile Manifesto, which seems to contain value statements that seemingly contradict the values at the core of a Quality Management System.

They also draw attention to the fact that as Agile evolved at a time when there was no criticality attached to risk management and human safety; the controls needed for producing software to which safety is critical have not been embedded into Agile.

Requires proper understanding and implementation

These points notwithstanding; Agile comes with a fundamental adaptability to the context it is applied in. Implementing Agile principles and practices in a proper way makes it more than adequate in an area like medical device software, where safety is critical. It is perfectly well-suited to accomplishing the lifecycle steps prescribed in IEC 62304 and risk management under ISO 14971. It can also help achieve usability design as required under IEC 62366

A learning session on the AAMI TIR 45

Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will offer thorough clarity on the area of the suitability of the Agile to medical device software. The speaker at this session, Brian Shoemaker, will unravel the elements of AAMI TIR 45 and explain how it can be applied to medical device software smoothly and effectively in a manner that meets regulatory requirements.

Please visit Agile Meets Software Standards to register for this webinar and derive the benefit of understanding how to apply Agile principles to medical device software.

At this webinar, Brian will help understand how the AAMI TIR 45 can be the ideal roadmap for facilitating and bettering development, which benefits everyone concerned, be they development teams, companies, patients, caregivers, or regulators.

He will put this in perspective by explaining the following topics:

o  Convergence: Agile principles and regulatory needs

o  Lifecycle: incremental development, design reviews, documentation

o  Key practices: planning, collective effort, product definition

o  Implementation: evolving architecture, emergent design, continuous testing, traceability

o  Managing your software: release, configuration management, third-party software, and CAPA

Brian will cover the following areas at this webinar:

o  TIR 45 comes at a much-needed time

o  TIR 45 stitches together the important high-level concepts

o  TIR 45 outlines key practices that are needed for flexibility and quality

o  Implementation issues are not ignored

o  This TIR is actually just a starting point.

For more updates and articles AAMI TIR 45

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Companies continue to increase transparency of external audit oversight

More companies are providing investors and other stakeholders with information about audit committee oversight of external auditors, according to the latest edition of the Audit Committee Transparency Barometer, an annual report released Wednesday by the Center for Audit Quality (CAQ) and Audit Analytics.

“For the fourth year in a row, audit committees have continued to enhance transparency around their oversight of the external auditor by voluntarily and broadly increasing disclosure,” Cindy Fornelli, executive director of the CAQ, said in a press release. The CAQ is affiliated with the AICPA.

The barometer found that 37% of S&P 500 companies’ proxy statements included enhanced discussions of the factors audit committees considered in recommending the appointment of the external audit firm. That’s up from 31% in 2016 and 13% in 2014.

The analysis, which also looks at mid-cap and small-call companies in the S&P Composite 1500, found that 24% of S&P MidCap 400 companies and 17% of S&P SmallCap 600 companies provided enhanced discussion of audit committee considerations in choosing an audit firm. Those percentages are up from 10% and 8%, respectively, in 2014.

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Misinterpretation of closed Data when Treated with “Normal” Statistical Methods

Geology is among the many branches of science in which compositional data (CoDa) arise naturally. In branches such as geochemistry, compositional data seem to occur typically, when one normalizes raw data or when one obtains the output from a constrained estimation procedure, such as percentages, ppm, ppb, molar concentrations, etc.

Compositional or constrained data have proved difficult to handle statistically because of the awkward constraint that the components of each vector must sum to unity. The special property of compositional data (the fact that the determinations on each specimen sum to a constant) means that the variables involved in the study occur in constrained space defined by the simplex, a restricted part of real space.

It is important for geochemists and geologists in general to be aware of the fact that the usual multivariate statistical techniques are not applicable to compositional data. They need to have access to appropriate techniques as they emerge and become available.

Pearson was the first to point out dangers that may befall the analyst who attempts to interpret correlations between Ratios whose numerators and denominators contain common parts. More recently, Aitchison, Pawlowsky-Glahn, S. Thio, and other statisticians have developed the concept of Compositional Data Analysis, pointing out the dangers of misinterpretation of closed data when treated with “normal” statistical methods.

Learning about all elements of CoDa

A webinar from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will throw light on all the important aspects of CoDa. At this session, Ricardo Valls, a professional geologist with thirty years in the mining industry, and who has extensive geological, geochemical, and mining experience, managerial skills, and a solid background in research techniques; will be the speaker.

To gain insights into CoDa, please enroll for this webinar by visiting  real case studies developedreal case studies developed

At this session, Ricardo will present several real case studies he has developed, to demonstrate the advantages of applying various aspects of the CoDa analysis in the search for and evaluation of ore bodies by comparing them with regular statistical modelling of geochemical data.

At this webinar, which will be of high value to personnel involved in mining, such as Geologists, Geochemists, Exploration Personnel, Graduate Students, and Post-Graduate Students; Ricardo will cover the following areas:

o  History of the Problem

o  The Current Situation

o  The Model

o  Normal Statistical Processing of the Data

o  Compositional Data Analysis

o  Factor and Principal Component Analysis

o  Dealing with zero and b.d.l. Values

Conclusions and Recommendations.

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What You Need To Know For Validated Systems?

Instances of cyberattacks that lead to disruption of service, data theft or compromise and even ransomware are making the news headlines of late with alarming frequency. Cyberattacks are carried out because computer systems used in highly regulated companies house very sensitive and valuable information.

Data relating to valuable electronic submissions, clinical information, medical device design control records, legal information, and other such information are usually placed in these systems, which is what makes them targets of cyberattacks. Cyber attackers have become so sophisticated and emboldened in recent times that they have not even spared the White House.

Computer Systems Validation has a major role

Companies that hold vital information should ask themselves many questions on this topic. Some of these include: Will my company able to cope with a breach of one of our validated systems? How secure is the information we have stored in the cloud? Are we conducting adequate due diligence on our cloud provider?

Even as the dependence on the cloud, by which life sciences companies are increasingly implementing and deploying systems in a cloud environment goes up; the procedures and controls to effectively manage and protect their validated systems environments is somewhat inadequate.

In the current situation of higher and stronger attacks on computer systems unaided by solid safety and security guarantees; Computer Systems Validation (CSV) has a critical role to play. Validation engineers need to take a serious relook at testing strategies. They must look at systems that provide objective evidence that computer systems have the requisite technologies, processes, and practices designed to protect networks, computers, programs, and data from attack, damage, or unauthorized access.

There is an acute need for validation engineers to be more vigilant in today’s systems environment that is sometimes hostile, in order to detect and prevent cybersecurity issues before they become real problems. Proper and diligent CSV goes a long way in helping to ensure that this happens.

Valuable learning on lean validation 

The ways of doing this will be the learning a valuable webinar from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance. Valarie King-Bailey, who is the CEO of OnShore Technology Group, an independent Chicago-based consultancy founded in 2004 specializing in Independent Validation and Verification (IV&V) services and solutions; will be the speaker at this webinar.

Please enroll for this webinar by visiting concept of Cybersecurity Qualification

Full aspects of cybersecurity

The regulatory, legal, compliance and business risks associated with the threat of cybersecurity constitute the core of this webinar. It will address the unique threat of cyberattacks on validated systems environments and discuss how to mitigate and protect validated systems.

As validation engineers continue to conduct IQ, OQ, PQ, CyQ testing must be added as a defense against cyberattacks to validate computer systems.  Valerie will discuss the NIST Cybersecurity framework and how it can be applied to validated computer systems. She will also discuss a new level of qualification for validated computer systems known as Cybersecurity Qualification (CyQ), a concept she will introduce at this webinar.

Being organized for the benefit of enterprise and validation professionals such as validation engineer, validation project manager or software quality engineer, and IT Managers, Directors, VPs, Chief Information Officers, Quality Assurance/Quality Control Managers, Validation Engineers, Validation Project Managers and Program/Project Managers; this webinar will cover the following areas:

o  The Cyber Threat Megatrends: What You Need to Know for Validated Systems

o  Understanding Cybersecurity Regulatory Guidance and Standards

o  Cybersecurity Qualification: The NEXT Frontier

o  Automated Testing in the Cloud

o  Top 20 Critical Security Controls for Validated Systems

o  Cloud Security Technology Maturity

o  Cloud Quality Assurance & Governance

o  The Changing State of Computer Systems Validation in a Cyber World

o  Understanding the NIST Cybersecurity Framework for Validated Systems.

Here to continue further How to mitigate and protect validated systems

How they take on water and therefore on how they react in the process

For any product that is being produced using the extrusion process; raw materials and their characteristics are the most important variable.

Grasp of why things happen as they do in the process and why the process and product being produced react as they do, can come about only when there is a basic understanding of the raw materials and how they flow, cook and potentially over-process.

Since different types of ingredients have different properties; each ingredient reacts very differently during the process and as the product’s defining characteristics are produced. For example, both starches and proteins undergo fundamental transformations during processing, but those transformations are very different from one another.

What complicates matters further is that most ingredients used in the process are a combination of the fundamental components (carbohydrates, protein, fat, etc.). So, all components are processing at the same time and undergoing a complex combination of transformations.

Insights into how raw material work in food extrusion

A fundamental understanding of the raw materials that are used, and their properties, is essential to knowing how to select raw materials during the product development phase as well as understanding how changes in raw materials are contributing to processing difficulties during production.

A webinar that is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will offer understanding of these matters relating to raw materials for food extrusion processing.

Dr. Brad Strahm, who is a Principal with the XIM Group, LLC, a firm providing consulting services in the area of product development, process engineering, troubleshooting equipment engineering, and project management; will be the speaker at this webinar. to know more about this area from this expert, please register for this webinar by visiting Food Extrusion Processing

Discussion of raw materials used in extrusion

Dr. Strahm will offer fundamental food-science information about the raw materials that are typically used in the extrusion process of food products. The material covered will include information covering the structure, characteristics and cooking of carbohydrates, proteins, fats, and other additives important to the food extrusion cooking process.

Dr. Strahm will talk extensively about carbohydrates, which will include extensive information about starches – the most common component in extruded food products. Other aspects such as structure, cooking requirements, selection based on flavor, appearance and texture will also be explained. The speaker will also explain other carbohydrates such as fiber and sugar and their impact on the extrusion process and on developing the functional aspects of the extruded food product.

Proteins and fats

Proteins are also very important in extruded food products, even though they react very differently and their structure is very different from that of carbohydrates. Proteins play an important role in meat analog products as well as in protein enriched foods that are popular today.

The speaker will also talk about fats, which are also an important component in extruded products and have a large lubricating effect on the process. Fats also have an important energy-dense role to play in food products. The particle size of the raw materials plays an important role in how they take on water and therefore on how they react in the process. In this discussion, Dr. Strahm will talk about particle size as well as particle size distribution and its impact on efficiently producing quality product.

Many additives that are often used in extruded products that have a large impact on the process and on the product produced will be discussed. The speaker will share a few tricks of the trade for modifying cell structure and texture with the participants.

In this webinar, which will be of high value and usefulness to professionals associated with food processing and cooking, such as Product Developers, Production Managers, Production Operators, Quality Assurance Technicians, Purchasing Agents and Maintenance Personnel; Dr. Strahm will cover the following areas:

o  Carbohydrates: starch, fiber, sugars

o  Proteins: plant and animal sources

o  Fats

o  Additives

o  Importance of particle size.

15 ways to stay healthy in college

With crispy chicken strips and addictive fries at the Pilot House, nine seasons of The Office on Netflix and the newfound freedom of college, staying healthy and active at school can be more difficult than it was back home. Whether you’re a freshman or senior, it’s undeniable that healthy eating and self-care often takes the back burner when you have to juggle school, jobs and a social life.

Health-sayings-stay-happy-stay-healthy

Some freshmen even might worry about the “freshman 15,” a.k.a. the weight gain that can happen when freshmen come to college. Tanya Bachman, nutrition instructor in the School of Nursing, said weight gain and unhealthy eating habits are common in college.

“I think it’s very common, not every single person is going to experience it but it is common,” Bachman said. “It’s being away from home and learning how to feed yourself, at the same time balancing academic load.”

Whether or not you believe in the freshman 15, everyone can agree that staying healthy in college is hard — both mentally healthy and physically healthy. The Beacon put together a list of 15 ways to stay healthy this semester.

1. Watch what you’re eating

2. Don’t skip meals

3. Avoid unhealthy snacking

4. Avoid sugary coffee drinks

5. Stay hydrated

6. Take vitamins

7. Use the Beauchamp Center

8. Take a fitness class

9. Try yoga and meditation

10. Get active with your friends

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U.S. asks China not to enforce cyber security law

GENEVA (Reuters) – The United States has asked China not to implement its new cyber security law over concerns it could damage global trade in services, a U.S. document published by the World Trade Organization showed on Tuesday.

China ushered in a tough new cyber security law in June, following years of fierce debate around the move that many foreign business groups fear will hit their ability to operate in the country.

The law requires local and overseas firms to submit to security checks and store user data within the country.

The United States, in a document submitted for debate at the WTO Services Council, said if China’s new rules enter into full force in their current form, as expected by the end of 2018, they could impact cross-border services supplied through a commercial presence abroad.

“China’s measures would disrupt, deter, and in many cases, prohibit cross-border transfers of information that are routine in the ordinary course of business,” it said.

“The United States has been communicating these concerns directly to high level officials and relevant authorities in China,” the U.S. document said, adding it wanted to raise awareness among WTO members about the potential impact on trade.

“We request that China refrain from issuing or implementing final measures until such concerns are addressed.”

China’s Ambassador to the WTO Zhang Xiangchen spoke on Tuesday at a WTO conference panel on trade protectionism, which he said was an underestimated problem that was causing a crisis at the WTO.

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