Why You Should Use an Electronic Quality Management System?

Today's fast-paced social and business dynamics will need business establishments to have proper management in document archiving. Most companies solve these issues by employing electronic document management services.

 

What are the benefits of electronic Quality management systems?

 

• Easy access: Thanks to the advanced search function, as well as the unique barcode system, accessing specific documents is both fast and simple.
• Improved workflow: Because documents are easily accessible, a faster and more productive workflow is possible. Employee productivity will be greatly improved.
• Lower IT costs: Since most EDM systems integrate with other common programs and systems within a business, IT costs can be kept to a minimum.
• Record backups: Electronic document management systems allow for maximum document control, especially in the case of an emergency. If a certain document is lost or damaged, a backup can be easily retrieved by the EDMS.
• Space-saving: There is no real need for the storage or archiving of hard-copy documents when you have an EDMS. This means that you save both space and money.

If you are interested in having one installed within your business, be sure to contact a reputable document management and solutions company for professional assistance. Orcanos is one of the leading and most reputable companies that have many years of experience providing integrated software for ALM (Design Control) and quality management (QMS), combined with regulations compliance, and specializes in the medical device industry. The software named Orcanos was founded in 2005 by Zohar Peretz and Rami Azulay. Our ability to tailor custom solutions using our vast experience and expertise, together with an integrated ALM and quality management system, sets Orcanos apart from other vendors and consulting bodies in the ALM and quality management domain.

 

Orcanos quality management system keeps all the data required to manage the quality processes in a single point of access. It enables companies to eliminate paper-based quality processes while following strict FDA regulations and ISO quality standards. 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.

 

This management system could very well replace the old-fashioned filing cabinets that are stuffed with file folders and papers. Today, people in legal, government, medical, corporate offices are storing and retrieving documents by computerized systems. This conversion also results in an environmentally friendly storage process. It can make your duties easier, faster, and more cost-efficient.

 

To make a long story short, implementing a good quality electronic document management software system is an excellent investment that will yield great returns for your business.

 

For more information or to know more about ORCANOS and the products or more please visit our website here; https://www.orcanos.com/compliance/

How CAPA MANAGEMENT SOFTWARE Can Help Your Business To Succeed?

Today, compared to any other area of quality management, CAPA is causing more compliance troubles for life sciences companies or organizations. According to the recent reports, nearly more than 83% of the warning letters are cited CAPA as an area of non-compliance even though most of the organizations were non-compliant in one or more areas. By considering the above factors, it is clear that your organization need a specialized software application for the management of CAPA because in most of the cases when an organization receive a warning letter, it means that the technology was in place but it failed for one or another reason.

 

But What Is CAPA Management?

The term CAPA stands for “Corrective Action and Preventative Action” and the main purpose of the system is to collect information, identify, analyze information and investigate product and quality problems and take appropriate and necessary action plan to prevent their recurrence. The CAPA management system also helps to verify or validate corrective and preventive actions as well as communicating the activities to responsible people by providing relevant information for management review. And then documenting all these activities is also very important if you want to deal effectively with quality and product problems and to minimize device failures and prevent their recurrence.

 

However, today even the paper-based,  home-grown or commercially available electronic management systems may meet minimum requirements of FDA. But as a business owner, if you want your organization to go further than just checking the box and want to capture and expand your market share then you have come to the right place. Orcano's CAPA MANAGEMENT SOFTWARE is a well designed comprehensive yet easy to use software system which is used to effectively manage your organization’s corrective action and preventive action processes while integrating with other processes. Managing these processes is very important in order to regulatory compliance such as change control, non-conformance, audits and customer complaints. As part of Quality Management System (QMS), Orcanos CAPA management software ensure regulations compliance, while completely automating process right from the initiation to investigation and closure which will greatly help you get more business.

 

Here are some of the following features of Orcanos CAPA system which includes:

• Best Corrective and Preventive Action Management
• Secured, centralized and electronic web-based system
• Traceability matrix to various quality processes such as FMEA, Training, Verification, ECO, Complaints etc.
• Prioritization
• Smart dashboards
• Action planning and root-cause management
• 21 CFR Part 11 compliant
• E-sign automation and workflow

 

Orcanos is one such platform which can help your business to convert each and every issue into an opportunity for improvement. And our highly designed Orcanos CAPA management software system is integrated with Orcanos e-QMS to support medical device compliance.

 

To know other details & information about ORCANOS please visit our website here: https://www.orcanos.com/compliance/

FMEA RISK MANAGEMENT And How It Helps In Managing Risk?

We all know that, for any organization to be successful in the market, identification of risk and eliminating the same is very important. The process of identifying and assessing risks and its various impacts followed by actions to minimize and control the impact of unfortunate events is called risk management. These risks can come from any field of business like uncertainty in finance, failure in projects, accidents, legal liabilities, etc. Various organizations follow different methods to find out the risks involved in a process. FMEA (Failure mode and effects analysis) is a step-by-step approach for identifying all possible failures in a design, a producing or assembly process, or a product or service.

identify the probable risk involved in a process. Now it has become essential for organizations to identify the risk and manage suitably to avoid huge financial losses.

Five ways FMEAs help manage risk

1. They start by providing a framework to develop a comprehensive identification of potential risks.
2. They assist with the evaluation of those risks in terms of how severe they could be, their likelihood of occurring, and the chance the potential failure has to be detected before failure.
3. They are a tool to decide which are the most serious risks.
4. They help point to ways to reduce the most serious risks.
5. They enable reevaluation to determine if the risk has been sufficiently reduced or if more work needs to be done.

To achieve an appropriate level, the session takes a broad view of the end-to-end supply chain - how to map it and identify the typical 'pressure points' where issues and risks are likely to occur. The focus is on identifying the risks from multiple perspectives by achieving true cross-functional and cross-company involvement and buy-in. The output from this becomes the input to a risk assessment exercise such as FMEA, the construction of which is explored.

So why should you use it?

FMEA is a tool to ensure that you have captured all possible causes and failure modes of your system. Ultimately, this system is effective at identifying and correcting process failures early on so that you'll avoid the nasty consequences of poor performance.

In the year 2005, the company named Orcanos comes into existence by Zohar Peretz and Rami Azulay. The one and the only company that provides integrated software for quality management (QMS) and ALM (Design Control) combined with regulations compliance. Orcanos Risk Management is meant to help medical device manufacturers to identify, track, and mitigate potential risks before they happen.. By using one system that connects design control, risk, and Quality Management, you'll reduce risk of failure, ensures hazards are mitigated, and prevents failure from happening .With years of proven experience in a regulated hi-tech industry, operating with medical device manufacturers makes Orcanos unique from others.

For more details and to know about FMEA Risk Management Tool or more please, call us at +972- 3-5372561 or visit our website HERE; https://www.orcanos.com/compliance/