Friday, March 27, 2020

Risk Management Widely Used Methods And Techniques



FMEA Risk Management




Do you think your business involves many risks and uncertainties? Maybe you are right. But, the truth is almost all businesses in the world have risks and uncertainties. And their impact is very significant and no one can overlook it.

A risk is an event that will affect the overall business objectives of an enterprise. It should be viewed as an opportunity rather than a threat that each enterprise should try to foresee so that the consequences of the events can be optimized. Sometimes, risks make the organization more alert, active, and responsible to create value for shareholders. If an organization is in a position to properly define risks and articulate them, then most of the objectives are achieved.

The function of risk management is to organize and carry out a plan to manage or reduce the risks to which a firm is exposed. This planning involves a five-step process. The first step is to identify potential risks. The method of identifying risks may depend upon the organizational culture, industry practice and compliance. Once risks are identified, the next step is to assess the potential severity of loss and probability of occurrence. The third step is to search out a potential treatment for the problem. This may involve the transfer, avoidance, reduction or retention of a possible risk. Next is to implement the plan by choosing the best method of treatment. Before implementation, a review and evaluation of the plan are important.

One of the widely used Risk Management methods and techniques today is the FMEA. Failure Mode and Effects Analysis or FMEA an analysis technique that facilitates the identification of potential problems in a design or process by examining the consequences of lower-level failures. This is generally used in product development as well as in operations management. This aids the managers in determining the potential failure manners that a system might give through the classification of the likelihood and the severity of such errors.

For the best Risk management tool, the company named Orcanos in the year 2005 comes into existence by Zohar Peretz and Rami Azulay. The only company that gives integrated software for quality management (QMS), and ALM Tools (Design Control) combined with regulations compliance and focuses on the Medical Device industry. Our FMEA Risk Management system software is designed in such a way to reduce and manage risks in a more effective way. With years of experience in a regulated hi-tech industry, operating with medical device manufacturers makes the Orcanos unique from others.

The ultimate goal in the pharmaceutical industry is to provide quality products and services that will eliminate diseases while at the same time ensure the safety of the patients. Therefore, by using a quality risk management tool, a lot of failures can be overcome, threats can be minimized, and their impact can be reduced.

To know or for more information about the Orcanos or more please, call us at 3-5372561 or visit our website HERE; https://www.orcanos.com/compliance/

Friday, March 20, 2020

Importance Of QMS Quality Management System



QMS Quality Management System








Competitive business industries needintelligent working strategies for better productivity. The primary focus of such strategies is to produce anefficient system and offer quality services with lesser time. Apart from advanced technologies, many industries are still following the traditional approachesfor data management. They used to collect and store thousands of paper documents in massive file cabinets ever year that requires more time and occupies too much space.

With E-Quality Management System you can replace huge file cabinets and improve efficiency of your business, reduce costs, and become more organized.A good Quality Management System (QMS)will:

  • Reduce Rate Of Errors
  • Improve Product Quality And Process Control
  • Increase Market Share
  • Lower Costs
  • PromoteTraining
  • CustomerExpectations
  • Raise Working Ability And Morale

Orcanos is providing best solution over this problem.

Orcanos Quality Management System offering the excellent, high-tech productivity tool that helps you to build quality management system through e-QMS infrastructure with minimum time.

Key feature of Quality Management System designed by Orcanos is sequential storage for database management. It maintains all the information in such as way that user can control the quality processes at the single point of access.

Withextended experience in a hi-techsynchronized industry, Orcanos e-QMS software delivering professional, easy to use, and secure tools, those assist businesses in building their operational superiority. These tools include Electronic forms (E-Forms), E-sign, Tractability tool, etc. with Automatic work-flows, ISO 13485 and ISO 9001 support. ECO,CAPA, and Professional dashboard is also implemented for trackingand controlling your data in real time.

To improve your company’s functionality and tocomply with quality standards of MDR/FDA regulations, get their Electronic Quality Management System plan. The plan composed of two plans – ALM for Research and Development (R&D management) and QMS. You can avail this plan with 30 days free trail.

About Orcanos

Software Companyhard earned by Zohar Preezt and Rami Azulay.Since 2005, Orcanosdesigning and developing integrated software projects for ALM (Design Control) including Quality Management system (QMS).

Choose best for your business! Explore quality range of Softwaretools and medical devices with Orcanos. Visit website:  https://www.orcanos.com/compliance/qpack-medical-compliance/   For more details call on +972-3-5372561. You can also mail your comments at info@orcanos.com.

Thursday, March 12, 2020

The Best Way To Application Lifecycle Management Software




Application Lifecycle Management Software




Today, many companies, software developers and teams that work on increasingly complex products still rely on legacy tools and still using single-point legacy solutions to keep track of their development processes. This makes the complexity of software development and keeping up with the increasing pace all the more challenging. This is the reason, today many companies all around the world realize that adopting an Application Lifecycle Management(ALM) Solutions can offer a variety of benefits in terms of traceability, software quality, collaboration and time to market. Application Lifecycle Management (ALM) software offers a countless number of benefits to all development intensive businesses especially for those who build, plan and sell software to customers and other third parties.

ALM software also offer benefits for those businesses or companies that provide IT home-based software development teams to develop proprietary software for internal use by workers. However, there are plenty of vendors available that offers a plethora of ALM software tools and the right platform you select can greatly affect your company’s success and your software development processes. Consequently, choosing the right application lifecycle management software that best supports and helps streamline your current as well as future processes is very important. If you are looking for The Best Way To Application Lifecycle Management Software and want to purchase the right ALM software then this article is just for you. Our main aim is to give you a hand in properly evaluating your options when purchasing ALM software.

As an IT business owner, if your development team's manual traceability is time-consuming and risk mitigations traceability is breaking up then Orcanos Application Lifecycle Management is the best solution. Orcanos robust, secured and simple ALM platform helps to increase efficiency and this enhancement of efficiency is achieved through the best practices in all relevant processes, creation and enforcement of standards as well as through the more precise and accurate provision of technology and human resources. We all knew that software development often requires involvement from various groups with different skills as well as conflicting priorities and goals. Orcanos ALM software brings development teams together that participate in the software development process including IT, engineering, quality management and QA staff by sharing of information among all key stakeholders and facilitating instant communication.

The development team of IT business without proper ALM software cannot produce the software at the best agility and speed required to continue to be competitive. Orcanos ALM tools help companies to meet all end-user needs and ensure that their software designs are built to the highest quality standards. Feel free to contact Orcanos for any kind of technology solution that can facilitate your application lifecycle management solution. For more details & other information about Orcanos please visit our website here: https://www.orcanos.com/compliance/

Tuesday, March 3, 2020

5 Ways FMEA MEDICAL DEVICE Will Help You Get More Business




FMEA Risk Management Tool
FMEA Risk Management Tool




The Failure Mode & Effects Analysis (FMEA) are important techniques applied in quality management. It is used to prevent errors, improve product quality to eventually increase product safety. Medical device manufacturers compulsorily apply it while in production. Other economic sectors such as the aerospace, automobile industry, etc. also implement the FMEA method for commercial benefits.

Different aspects of FMEA contribute to avoid the general errors,also increase operating reliability of medical devices. Through early testing, detection and elimination techniques one can easily find potential weak points.

Medical devices manufactured with FMEAensure first-error security and so the risk is reduced at an early stage. Apart from the product safety, there are some economic benefits of an intensive FMEA implementation:
  • Reduce errors in the manufacturing as well as product use.
  • Avoid undesirable development, duplication of work and save development time.
  • Eliminate repetitive errors.
  • Reduce serious accidents and productivity failures.
  • Enhance quality awareness in employees.
  • Improved exchange of information, skills, and experience.
  • Increase cross-departmental cooperation.

With long years of great experience in a hi-tech regulated industry, Orcanos is assisting medical device manufacturers including other high-tech industries in building their operational excellence. Their CAPA and FMEA Medical Devices allowclients to manage their work, improve quality and productivity. Streamline compliance regulations such as IEC 62304, ISO 14971, andISO 13485 are better complying with regulatory authorities like FDA and CE.

Applications designed by Orcanos facilitate various key features such as easy access, smart dashboards, real-time alerts and many other through which customers can track progress of their ongoing projects.

The company founded byRami Azulay and Zohar Preezt in the year 2005.Orcanos is the only business inarea that helps their clients to implement integrated ALM (Design Control) software & Quality Management (QMS). The company also provides industry-based regulatory compliance and specializes in medical device industry.

You can select FMEA risk management, security and management plans as per your need by visiting website https://www.orcanos.com/compliance/fmea-risk-management-iso-14971/ Talk to their experts, call on +972-3-5372561 or share your queries at info@orcanos.com

Wednesday, February 19, 2020

The Importance of Electronic Quality Management System

As technology continues to evolve and individuals become more technologically sophisticated, companies must keep up with technology's rapid pace by sourcing leading-edge tools to manage both customers and internal processes. Managing quality and processes manually is a daunting task without the proper tools and may lead to a myriad of problems, including delays in project timelines, poor customer satisfaction, lack of motivation, and poor allocation of resources. To address these and other issues, the use of an electronic quality management system; is highly recommended to save time and costs associated with process documentation, non-conformance management, and risk reduction.

One of the most important parts of running any successful business or organization is to make sure that you always have clear precise documentation of every single important transaction, process, and action that takes place. This will allow you to have a transparent reference point whenever anything is in question.

Orcanos Software comes into existence in the year 2005 by Zohar Peretz and Rami Azulay. The only company that gives integrated software for ALM (Design Control) and quality management (QMS), combined with regulations compliance, which specializes in the Medical Device industry.

The unique thing about us is our years of proven experience in a regulated hi-tech industry, working with medical device manufacturers and other high-tech companies, and assisting them in building their operational excellence.

Businesses need to keep careful track of issues that require attention, and for that, they rely on CAPA Management Software. This is a type of software that allows personnel to record and keep track of corrective action requirements in whatever form they take. Such software can be used to track customer service complaints, employee complaints, supplier non-conformance, or virtually anything else which requires deliberate action.

CAPA is a part of the Quality Management System and is one of the key elements of a management system that is directed towards continuous improvement and customer satisfaction. CAPA also known as corrective action / preventive action, refers to the steps taken by an organization to eliminate the causes of non-conformities. CAPA Management System is a process by which the organizations get rid of detrimental results by focusing on the desirables.

Don't let your company get weighed down with mountains of paper documents and rooms full of filing cabinets. An electronic data management system will make your business operations faster, more efficient, and more competitive. CAPA compliance will lead to a better process and a better product that will ensure customer satisfaction. In today's competitive world, CAPA is a necessary tool for organizational growth. CAPA Software is used to report and then implement corrective and preventive action to eliminate the causes of nonconformance.

To know more about Orcanos or more please, call us at 3-5372561 or visit our website HERE; https://www.orcanos.com/compliance/

Wednesday, February 12, 2020

Why Do Organizations Need Application Lifecycle Management Software?



Application Lifecycle Management Software




The common question that most of the business owners have is that “Is it really important to have Application Lifecycle Management (ALM)?”. If you too have the similar question on mind then as a business owner you need to know that if your organization is experiencing deployment predicaments or application development then application lifecycle management software may be the right fix.

So, What Is Application Lifecycle Management (ALM)?

ALM is a complete lifecycle of a software application which maintains the process of the application starting from its requirements, to its development, testing framework, resolving issues and deployment by improving software quality and also intended to help in business management. Compared to SDLC that only covers the development stage, ALM without sacrificing quality, it helps deliver releases on time and manages the entire lifecycle and hence it is comprehensive

In reality, all the projects and even the smallest projects have to be managed in some way and Although ALM may not work as a magic bullet, it is effective in addressing most of the challenges not only of application maintenance and development but also the challenge of life. If you want to deliver your project on time without compromising on the quality, then an integrated system of ALM Tools helps to administer the life of an application right from conception to it being absolute. We know that each and every organisation requirements vary and they benefit from ALM Tools differently. Thus, keeping this in mind, Orcanos is one such leading company that provides ALM tools that are designed to be benefited in one or other forms.

The Orcanos ALM software tools help in project management by resource planning and we provide tools for different requirements that can be used either for Agile development projects or traditional waterfall project or for both. Here are some of the benefits of application lifecycle management

  • ALM helps the business in organising and preparing
  • The collaboration of multiple teams
  • Better quality, speed and compliance
  • Productivity of team
  • Resolving and testing
  • Decision-making ability
  • Greater customer satisfaction and employee support

Orcanos is also a trusted leader in the Requirements Management System. Our requirements management system helps to manage, define and validate complex system requirements by eliminating inefficiencies and appropriate risks associated with legacy systems and documents. Having Requirements management for your company helps to streamline your development process and it also helps to optimise processes and increase efficiency by accurately communicate and capture requirements, goals, progress to remove friction throughout the development process. By using Orcanos requirements management system, it helps to speed up the product development process by saving a lot of time, strengthening alignment and ensures quality and compliance. For more information about Orcanos please visit our website here: https://www.orcanos.com/compliance/

How the CAPA System Improves Pharmaceutical Production Quality


CAPA Management Software







With constant research many new devices and methodologies are being invented. And Technology makes it critical to make sure that there are proper regulations for the improvement of medical sciences. It is a true concern on the part of the govt. that they strive for quality and perfection. Medical devices play a very important role in diagnostic processes. Thus, it is important on the part of the government to maintain the highest standards to regulate them. But it is not always easy to maintain the highest standards. On many occasions, the concerned firms fail to retain such standards that are specified by the concerned government authority. One of the major causes of such failure is a lack of knowledge. But such a scenario will be successfully battled with correct consulting and training processes.

This is why the pharmaceutical industry is often used as the benchmark to enhance the CAPA system. CAPA or Corrective action and preventive action is a method that is followed by organizations to eliminate damaging results, by concentrating on the desirables. It comes under the scope of good manufacturing practice (GMP) and also the ISO standards. The key features of this process include analysis of the root cause of the problem, and implementing specific actions based on such analysis.
Some of the steps of the CAPA system include –

  • Root Cause Analysis
  • Identification and Adaptation of Corrective Action
  • Development and Adaptation of Preventive Action
  • Implementation of the Preventive Action

Orcanos Software comes into existence in the year 2005 by Zohar Peretz and Rami Azulay. The only company that gives integrated software for ALM (Design Control) and quality management (QMS), combined with regulations compliance, which specializes in the CAPA Medical Device industry.
The unique thing about us is our years of proven experience in a regulated hi-tech industry, working with medical device manufacturers and other high-tech companies, and assisting them in building their operational excellence.

Orcanos CAPA system includes Tractability to other quality processes, such as FMEA, ECO, Complaints, Training, Verification, etc or much more. With fully Customizable CAPA forms: no more paperwork. And:

  • ALM+QMS
  • Document Generator
  • Integrated Risk Management
  • Electronic Signature
  • Fully Customizable
  • Personal Dashboards
  • Real time Alerts

FMEA (Failure Mode and Effects Analysis) is a management activity intended to assess actual and potential problems, assign a risk factor and choose a course of action. This method is used in many industries like automotive, FMEA Medical Device manufacturing, aerospace, and chemical processing.

Good Orcanos CAPA software systems provide the tools for this type of advanced root cause analysis to support conforming corrective and preventive action processes and customer satisfaction.
To know more about Orcanos or more please, call us at 3-5372561 or visit our website HERE; https://www.orcanos.com/compliance/