Requirements management tool for medical devices

A company involved in the manufacturing and design of medical devices has to spend a lot of time on research in design and development. Companies spend millions of dollars and manpower just to design the framework of the manufacturing process and making guidelines for the safety of the device.

What is the need for a requirement management tool?

If the fault or an error is found in the device it can lead to a recall of the device. This will hamper the reputation of the company manufacturing the device. The sale of its medical equipment may fall and clients may retract their orders.

If the lives of the patient are at stake due to any technical glitch then the situation is even worse. This could also lead to fines by regulating bodies and your company may even lose license for manufacturing medical devices.

How can a requirement management tool help the manufacturing industries?

The use of a requirement management tool is to help the device manufacturing and designing team in three parameters.

Finding our the requirement of a medical device

This is important to start the design process. A medical device should be manufactured to help surgical and operating procedures and save lives. This is done to ease the workload of the medical personnel as well.

Mitigate risk

It is done to mitigate risk especially the mishaps and unfortunate events. If the lives of patients are compromised due to faulty equipment then you have to face lawsuits in the court rater than designing medical devices.

Do case-wise testing

The testing phase will enable the experts to find out all the cases and possibilities while doing the testing. Emphasis is given to all the operating procedures of the equipment based on certain conditions.   

What are the things that you have to consider choosing a best requirement management tools?

Finding out traceability

Traceability is a term that increases the efficiency, and risk in designing and manufacturing procedures. It is an important parameter that helps you to focus on the functionalities of your medical device.

Will the tool help you to identify the risks

Risk management is very important both in the design process and when it is being used in medical institutions such as hospitals and pathology centers. It helps you to find out the design flaws or loopholes in the device that may cause an accident.

Ease of use

It is very important to look at how easy it is to use your requirements management tools. As it will be used by the design and development tool you have to ensure that all your staff knows how to use the tool to adopt safer practices.

Are you searching for the right tool? Then visit Orcanos website because they have the right tool for all types of medical devices manufacturing industries. For more information about please, visit https://www.orcanos.com/compliance/  

Complete Automation of CAPA Process in Orcanos QMS

The Corrective and Preventive Action also referred to as CAPA is a very important integral part of any quality management system for pharmaceutical industries. Having an effective CAPA ensures that your company or organization is constantly working towards reducing the failures in the production, weakness, or testing of drugs and digging deeper for investigating the root causes and problems and then learning and improving them from these causes. The corrective and preventive actions empower the organization to correct the existing nonconformity of product and quality issues and then preventing the occurrence of the problem. If the FDA auditor is not satisfied with your quality management system (QMS) to manage CAPA then as an organization owner, it may cost you with a penalty and you may receive a warning letter.

The perception about CAPA differs from company to company; some think CAPA as some kind of task given to them to complete in order to stay compliant, while others look at CAPA as a number based metric that needs to be reduced immediately. But you need to know that CAPA is actually used to effectively manage the complete lifecycle and in simple words, it is also defined as a system which provides the tools for the complete evaluation, identification and investigation of a deviation. CAPA empowers quality management system (QMS) to be self-correcting and the tools are used to determine, implement and check the effectiveness of a resolution.

Today, most of the companies using a manual paper-based system for managing CAPA and this are the reason; all those companies are facing complexities such as:

• Poor communication
• Poor CAPA reporting
• Unsecure system and error-prone
• Lack of CAPA oversight
• Consume cost, efforts and time

Orcanos is the only reputable company that provides CAPA automation software which is specially designed after experiencing the industry-wide requirements to effectively manage the process. And this software is also used to integrate it with another quality process for attaining compliance. Orcanos CAPA automation software solution helps an organization to get complete automation of CAPA process in Orcanos QMS System and also make sure that all measures are identified to solve the issues and also ensures that the complaint related to quality is taken care of. It also provides a single unified platform for electronically evaluate, identify, analyze and investigate the incidents and also helps to make sure that similar types of errors are not repeated.

Orcanos CAPA management system as part of Orcanos Quality Management System (QMS) ensure all the regulation compliance, while completely automating CAPA process from the beginning stage to investigation and closure. Our Orcanos CAPA system is fully integrated with Orcanos electronic quality management system (e-QMS) to support medical device compliance. To know more details about Orcanos please visit our website here: https://www.orcanos.com/compliance/

ISO Standards 101 - Understanding the basics of ISO Quality Management Systems

There are more than enough ISO standards to confuse any organization that's looking forward to getting certified. Today, there is more than 16,000 point of compliance being used by certifying bodies to assess, monitor and audit any organization seeking to improve its quality management system. Here is a brief explanation of what these standards are and their specific usages:

ISO Standards

ISO9000 compliance contains the metrics or specifications required in order to attain the guidelines or criteria specified under that series. These standards referred to as the in order to group the compliance guidelines used for quality management and assurance. An International Standards Organization is identified as the series and its version. For example - the ISO9000:  family of quality management.

ISO 9000: This is a very popular standard, starting from ISO9001 to ISO9999. The ISO 9000 family of standards deals mainly with the use of quality management systems to make sure that the customers and clients of an organization have their needs met. Over one million organizations are ISO 9000 certified worldwide, making it one among the foremost used standards created by the international organization of Standardization. When organizations are ISO 9000 certified, they're telling their customers that they want to deliver quality products and services to them, also as communicating that they have plans in place to ensure that quality is always managed and is one of the organization's biggest concerns.

The International Organization for Standardization (ISO) was established with the purpose to ensure and supervise the quality of products and services, which created the Quality Management System (QMS) standards in 1987.  According to these standards, there are certain basic principles for quality management, which are-Customer Focus, the involvement of individuals, evidence-based decision making, and relationship management.

In the year 2005, the company named Orcanos Software comes into existence by Zohar Peretz and Rami Azulay. The only company that has integrated software for ALM (Design Control) and quality management (QMS). ORCANOS CAPA (Corrective Action and Preventive Action), as part of Orcanos QMS, ensure regulations compliance, while automating the CAPA process completely, from initiation to investigation to its closure. The thing which makes us unique from others is our years of proven experience in a regulated hi-tech industry, operating with medical device manufacturers and other advanced corporations and assisting them in building their operational excellence.

Which ISO standard is right for your company?

The choice of ISO standard your organization will apply for will depend on the kind of company you have, the nature of its business, its production or manufacturing processes, the type of products and/or services involved and the quality management system you want to achieve.

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