Orcanos Software @orcanos - Tumblr Blog

Fully Customizable CAPA Form

When it comes to a business or organization, productivity is everything. The more productive you're in all areas of your company the more successful you will be in the future. Fortunately, CAPA - Corrective and Preventative Action - can help!

What is the definition of CAPA Software?

It is an abbreviation of corrective action and preventative action software which can be considered a vital tool designed for any business quality management system. In simple words, this is a kind 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 needs deliberate action.

It keeps the issues extremely visible in order to force the user to solve them. It also allows the user to connect relevant images or other information in order to better organize the corrective action requirements. By allowing the linking of information, contacts, and cross-references, the software helps the user determine the right course of action and therefore the proper personnel to notify.

Below are the defining steps of the CAPA system include –

(i) Root Cause Analysis: This is the primary step to the application of the CAPA process, and it's to do with laboratory analysis or a close audit of documents that relate to the problem or complaint. This identifies the particular problem for the later stages of the process.

(ii) Identification and Adaptation of Corrective Action: These are the immediate steps to address a present complaint; which may have to do with product replacement, and various steps to provide relief to any persons directly affected by a faulty product.

(iii) Development and Adaptation of Preventive Action: In CAPA for Pharma, developing a preventive action indicates the various steps for addressing a complaint or discrepancy on a long term basis. This may include decisions like a product recall, or rectification of a regular system.

(iv) Implementation of Preventive Action: The final stages to the CAPA Medical Device, implementing a preventive action ensures that future incidents relating to a complaint or discrepancy are prevented.

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 CAPA (Corrective Action and Preventive Action), as a part of Orcanos QMS, ensure regulations compliance, while automating the CAPA process completely, from initiation to investigation and closure. 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 Orcanos or more please, call us at +972- 3-5372561 or visit our website HERE; https://www.orcanos.com/compliance/

Integrated Quality Management System

An Integrated Management System (IMS) combines other International Standards, such as Quality Management System (QMS), Environmental Management System (EMS), and workplace safety management (OHSAS). The aim is to deliver a coherent overall management package that helps an organization meet its requirements and deliver on-time quality products and services. Some of the immediate benefits an optimum quality system can offer any business include:

Quick return on investment

Significant administrative time and cost savings

Increased chances of market success

Solid infrastructure for a robust system that supports quality-related tasks and processes throughout the organization

Every business faces the challenge of ensuring the entire quality management system is well connected between departments and teams. One of the sure ways of optimizing a quality system is to have all quality processes connected through a central system and removing silos of information throughout the company. It's a common occurrence that during an audit or survey, a change in the process or non-conformance is highlighted. A process change may impact three to four departments, therefore, having a centralized system that triggers a required action, based on an identified issue, and would save man-hours in transcribing the findings and then communicating to each stakeholder separately.

With years of proven experience in a regulated hi-tech industry, operating with medical device manufacturers makes Orcanos unique from others. One of the major benefits of an IMS is to reduce duplication and risks, which leads to a reduction in costs and an increase in profitability. It helps build relationships rather than conflicting responsibilities.

An Integrated Management System ISO brings many benefits. An ISO IMS is a very important business and management tool, helping to reduce costs and increase profits. And for individual businesses, it can help in the search for new markets and increase customer satisfaction.

But best of all, it means everyone within the organization is singing from the same hymn sheet and working towards the same goal, and that has to be a win-win result!

A good quality management system in a pharmaceutical company can significantly improve the net profit status, best quality medicines for patients, less rework and recall which save extra money, good work environment, and compliance with local and international regulations.

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

72 Hours to Automate Document Control

Document version control software is something that many companies employ to arrive at and maintain compliance with industry standards because the amount of money of data and information flowing through businesses keeps growing, and agencies such as the FDA and ISO will expect companies to trace every change that any user makes to the given document.

Many companies waste numerous time and expense searching through countless documents and unstructured information. This is detrimental in a couple of ways. One, it makes it very hard to produce the actual versions of the right documents when regulatory agencies demand them. Document version control software to consider good care of these problems, though. These solutions were created to track every change that was made to a document and to control the authorized users so just one person can edit the document at this time. This makes sure the version is correct and also the document will keep its integrity and transparency. It will stay in a centralized and secure location.

So how can a document control system save your organization time and costs in the management of critical company information?

A document control system software usually is the repository of documents that provides secure control of all documentation in the organization. With this type of software, you can improve communication, traceability, compliance, and control over key business processes.

To highlight a few ways in which an electronic document control system can assist a business, we've listed some ways here:

Easy Search and Retrieval

The first advantage of automating document control is going paperless.

Quick Process Approval

Using document control software allows you to send your documents electronically and assign different rights to the concerned manager.

Effective Information Management

Electronic control of documents will ensure your customer service and sales teams are accessing the most current information and constantly sharing that with prospective clients and customers.

Regulatory Compliance

When dealing with regulatory authorities, having the right information available at the right time can prove very useful for the business.

With the growth of technology and increasing demand for electronic document management system software, an organization of any size can easily find a solution that will fit into their business need and their budget. 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. With Orcanos 72 Hours to Automate Document Control, you can be assured that no document is overlooked, and document cycle time is reduced significantly while assuring compliance with regulations. 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 Orcanos or more please, call us at +972- 3-5372561 or visit our website HERE; https://www.orcanos.com/compliance/

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/

CAPA Management Software

Get complete automation of your CAPA process in Orcanos QMS as part of Orcanos QMS, ensure regulations compliance, while automating CAPA process completely, from initiation to investigation and closure

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

They start by providing a framework to develop a comprehensive identification of potential risks.

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.

They are a tool to decide which are the most serious risks.

They help point to ways to reduce the most serious risks.

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/

Which Software Asset Management Tool Works Much Better For All Assets Of A Firm?

To manage every software asset belonging to a firm, you need a tool that can handle all the different types of software and their skills. More than that, it should provide features and perks mentioned below:

Real-time dashboards with alerts

Depend on that tool, which can help visualize the content or the usability of a firm’s software asset effectively. In addition to that, put the alerts on to get the timely notifications about the updates. The improvements in the same visualizations hung up on the dashboard of a project analysis related to a single or multiple software.

These alerts are necessary to stay updated with the market trends. This is one of the vital roles of having a Agile Requirements Management Tools in your firm. Without the latest trends, you won’t know if the software you are using is enough for the project you run or the products you sell.

Owns up a central repository for every software and risk management sheets

Have a tool that can easily integrate all the data files into one place. You don’t want to depend on multiple software for conducting a quality analysis of thousands of other software. That would just be cumbersome and render no benefit to anyone at all.

Thus, have a single software that can run multiple projects at once, or else, it can store all the project files in a central repository. With this, the task to edit, retrieve, download, or share the results becomes easier for the firm's software asset management officers or supervisors.

It should generate the required documents related to the risk, success, and failure of any software

Find that tool that can easily generate the reports for an easy explanation to the senior management. If you are a project manager, you must know that working on a tool or software isn’t the only task.

You need to be able to explain to your seniors or the stakeholders about the risk, success, as well as causes of failure. And at times, graphics are not enough. You need to have proper case studies, or the sheets tracing the entire project from day one.

That is why generating documents is quite necessary for those software asset management tools to work for a long run in the organization.

Can help integrate different modules

Whenever you are developing a software or testing its quality, you are working on multiple functions of an organization.

This includes R&D, cost analysis, risk analysis, and quality checks. Therefore, you need a tool that can integrate the results or the inputs to be drawn from each department to know what type of software is the requirements management tools dealing with.

Conclusion:

Browse this site https://www.orcanos.com/compliance/products/requirements-management/ to get the latest tool helping every organization in timely software asset management provided by Orcanos.

Top 3 Considerations While Working With A Best Document Management System

Being a new-age and smart organization owner, you might want to serve all your clients with the utmost efficiency. And it is pretty simple by automating operational tasks using modern software tools. The Document Management System is also known as DMS is the most important and widely used application by many organizations all over the world. Gone are those days when the organization depends upon the use of piles of papers, files and folders to manage their documents in the business. The document management system revolutionizes the way you manage your business documents. So, go paperless by implementing a versatile document management system and prove to the world that you are a progressive entrepreneur.

What is a Document Management System?

A Document Management System (DMS) is a digital application that is used to store all your business records and provides you and your staff with the best portal to access all those records. There are several other names that are used to describe similar applications such as electronic document management system, enterprise document management system, records management system, content management system and many more. And all these applications pretty much do the same thing so you don’t have to sweat the jargon.

Today, in order to run a successful business, having secure access to and storage of digital information is very important and a Document Management System Software can help you by providing the software solutions that greatly provide access to your digital information or data in an easy and most effective way. With so many different software options available, getting a good document management system can be nerve-wracking and a daunting task. So, following are the top 3 key considerations that you need to consider while choosing and working with a document management system which includes:

Security: When selecting a good document management system to work with, along with easy access, security is also an important aspect of a DMS and you need to make sure that they are also secure.

Compatibility: When you buy a DMS, you need to make sure that it is compatible with the existing systems and integration must be seamless and without any jerks.

Quality: You need to know about the company that makes DMS and choose only those products that are done well and got good reviews.

Orcanos is the one such company who have their previous products done well and have gotten very good reviews from the clients. Now you can reduce bottlenecks on documents routing and signoff by choosing our well-designed document control software. Therefore, if you’re someone who's looking for the best DMS software for your business then choose Orcanos fast and swift document management systems and become a trendsetter. For more information to know about ORCANOS please visit our website here: https://www.orcanos.com/compliance/

Importance Of Choosing Orcanos CAPA System Integrated with ORCANOS e-QMS

The Corrective and Preventive Action also known as CAPA is the most important tool that is utilized by many organizations worldwide to identify, avoid and resolve non-conformances. CAPA also defined as the improvements made to an organization’s processes taken to eliminate causes of undesirable situations and non-conformities. In an attempt to prevent their recurrence for corrective action or preventive action, it focuses on the systematic investigation of the root causes of identified risks or problems. Just the way it sounds, the CAPA management system consists of two main elements that are corrective and preventive action and both these actions have one main aim that is to improve the quality of processes. Although CAPA processes have been employed by many organizations all over the world, they have been evolved correspondingly with the advancement in the new technologies and strategies.

Today, it has become a common tool to be integrated with many applications in IT architecture and it also plays a very crucial role in the global quality management system initiatives. According to the report, it is said that in the recent year, more than 83% of warning letter has been cited CAPA as an area of non-compliance at FDA regulated organizations or companies, even though most of these organizations were noncompliant in one or more areas such as CAPA purchasing controls or process validation requirements. So, by considering the above factors, it is clear that organizations need to have a specialized robust software application for CAPA management system or an electronic quality management system (eQMS). In this article, we will discuss the main elements of Orcanos CAPA system is integrated with ORCANOS e-QMS to support medical device compliance.

Orcanos is one of the leading and most reputable company that have many years of experience providing complete automation of the CAPA process in Orcanos quality management system (QMS). As part of Orcanos QMS, Orcanos Corrective Action and Preventive Action (CAPA) ensure regulations compliance while completely automating CAPA process from the beginning stage that is an initiation to investigation and closure. Orcanos CAPA Management Software includes the most secured and centralized web system and also have traceability to other quality processes such as FMEA, verification, ECO, Complaints, Training etc. Today, the first-in-first-out methodology for CAPA has been used to reduce non-conformances and this is the reason, it is becoming more common for many companies worldwide to integrate CAPA and non-conformance reporting modules with electronic quality management system (eQMS) and many QMS solutions have this built-in capability.

In order to support medical device compliance, Orcanos CAPA system is integrated with Orcanos e-QMS. No matter whether it has risk associated or a resolution requires an engineering change, Orcanos links the quality management artefacts using traceability tool and strives to provide impact analysis and better tracking. To know more details and other information about ORCANOS please visit our website here: https://www.orcanos.com/compliance/

Document Management Software - Keeps Your Business data secure

In business, there is tons of paperwork that needs to be filed and kept properly for documentation purposes. Oftentimes, there are problems in finding misplaced papers that cause more delays in the transaction. But in the advent of technology, document management software is now utilized to solve these types of problems.

What is document management software?

Document management software is a tool used to systematize your files. Instead of keeping tons of papers and searching each one for a single file, the software saves a digital copy of the file through the use of a scanner. It will then be saved on the computer. You can share the files with your colleagues so that you can work together, making the completion of a task faster. If you want to know how and why document management software can be useful to your business, here are the top reasons I summarized for you:

Faster search options

It allows you to regulate the distribution of files.

It reduces the need for storage.

It has disaster recovery features.

It can help you save money and time.

Securing business data is again a very big concern in paper documents. Not only are paper files at risk of misplacing, they're also vulnerable to theft and physical damage. Although digital documents to are susceptible to physical damage, the simple backup and recovery eliminate this problem very effectively. Apart from this, the access system in document management software allows only authorized personnel to access the files. Similarly, different levels of security are often set up depending on the need. For instance, a file may be read-only for a department, whereas modification or update rights can be given to higher management or others as required.

Choosing the proper business document management system specific to your business requirements is extremely important. 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.

By automating document workflow, Orcanos software can assure that no document is overlooked, and document cycle time is reduced significantly while assuring compliance with regulations. 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.

To know more details and other information about ORCANOS please visit our website Here; https://www.orcanos.com/compliance/

#Cloud Document Management System

ISO 14971:2019 Compliance: Trace to design control mitigations

The ISO 14971 is an ISO standard for those companies involved in the manufacturing of medical devices. It intended for improving company processes and standardizes manufacturing procedures so that the risks associate with electronic medical devices can be mitigated. It is a set of points for risk management and adopting best practices while developing a device used in the medical industry.

There are three different versions of the ISO 14971

ISO 14971:2007- This was the first standard that was made by the world governing body for medical devices. It was replaced by the ISO 14971:2019.

ISO 14971:2019- It replaced the ISO 14971:2007 certification. It has new chapters included in it and focuses mainly on the benefit-risk ratio. It also includes information that has to be passed on to the next phases for safer use of the device.

EN ISO 14971:2012- It is intended for manufactures of medical devices in Europe only.

The ISO 14971:2019 has three main objectives

Implementing the safety standards right fro he planning phase of manufacturing

Designing medical devices is a complicated process. This feature as stated within the ISO Document Control Software is to mitigate the hazards in the medical industry by use of safe manufacturing process. It deals with removing those features that could be selected by mistake or by error.

The safety while using the medical devices can also be increased by the use of labels and displays beside each switch, plug, or socket. Also, there should be a process to automate the device functions to avoid the error. It can be used for doing the minute tasks where the chances of error are high.

Include measures to protect or contain the damage within the device itself

This point explains the need to incorporate safety measures in it and also the mechanisms in the event of wrong input. These may include safety measures such as using safety guards, shields, or manual override to contain the activity. It includes providing warning displays to warn the user while using the device such as low battery warnings on devices. This would prevent stalling a device operation midway while conducting surgery or anything similar.

Safety information

This includes users to hand a device manual which gives a thorough guide on how to use the device. It also includes providing training to the users of the device.

What are the benefits of ISO 14971:2019?

It can avoid the wrong happenings such as injury or accident

Optimum use of the device for improving medical infrastructure

Develop better surgical procedures that focus on the safety of the user and the patient

Streamlining manufacturing processes and issuing standard guidelines

Orcanos is a risk management tool designed to help medical device manufacturers. It is considered to be the best for providing an integrated solution, providing traceability, and is fully online. Visit the Orcanos website for more details: https://www.orcanos.com/compliance/

Integrated Design Control and QMS

To introduce, ISO 9001 QMS (Quality Management Standard) was designed and introduced by the ISO to help organizations ensure a better quality of products and services to be able to grab a larger market share and ensure greater customer satisfaction. A strong QMS is a necessary part of achieving prime quality to please customers. The QMS aids in making and maintaining the simplest set up of action for doing business. The QMS systems provide a way to deal with problems requiring corrective action and for determinant causes of insubordination. The QMS and audit system also produce a mechanism for implementing preventive actions to eliminate the foundation reason for quality problems. As a result, if the very best quality isn't achieved, the system itself is the instrument for correcting that.

A QMS Quality Management System is required for any organization which desires to demonstrate its ability to consistently provide products that meet both customers' needs and the applicable regulatory requirements. When a Quality Management System; is implemented, it paves the way for an integrated enterprise with interacting processes. This helps in the smooth functioning of the operations resulting in profitability. QMS helps to efficiently control business processes and their interlink ages. Furthermore, it can help you in overcoming market barriers paving the way to fiercely compete in global markets.

Perhaps one of the more important aspects of a QMS is that you'll be able to make continual improvements in how you run your company. From managing your risks better to driving down operating costs, from improving your market share to increase your customer satisfaction, your QMS will provide you with an edge over all your competitors. Also, once you get outside certification for your QMS, particularly for international standards such as the widely used ISO 9001, your business attracts new clients.

In the year 2005, the company named Orcanos comes into existence by Zohar Peretz and Rami Azulay. The only company that provides Integrated Design Control and QMS or Quality Management Software, and ALM (Design Control).Our years of proven experience in a regulated hi-tech industry, operating with medical device manufacturers make us unique from others. At any point, Orcanos enables you to get data into Word documents and e-sign them in Orcanos DMS, or directly sign electronic records

Integrated Design Control and QMS enable all stakeholders, whether its R&D, QA, RA, or management, working with a single repository system that combines it all together document Control, CAPA, Change Control, Risk Management, Requirements Management System, and more. We are also flexible enough to serve SMBs and powerful for enterprises. ORCANOS CAPA (Corrective Action and Preventive Action) ensure regulations compliance while automating the CAPA process completely, from initiation to investigation and closure. To know more about Orcanos or more please, call us at 3-5372561 or visit our website HERE; https://www.orcanos.com/compliance/

#Requirements Management Software

How To Ensure Integrating Design Control, Quality And Regulation Compliance?

If you own an organization in highly regulated industries such as life sciences, it is important to make sure that everything is dotted and crossed. Today, the US FDA and other regulatory agencies have strict regulations and requirements for document control, integrating design control, CAPA, training and other aspects of the operations. As an organization owner, you have to make sure that your each and every process must support continuous compliance and your organization needs to be ready to respond to any kind of requests for regulatory changes or documentation. If you are someone who is just getting started then ensuring your procedures and processes are complaint can feel like a daunting and overwhelming task. Your organization need to create and implement a well-designed quality management system which can scale.

In this article, we will tell you how to ensure that your organization maintains Integrating Design Control, Quality And Regulation Compliance and the best company that provides all these software tools and services. As an organization owner, you need to know that your organization will be responsible for creating a good quality management system (QMS) which will greatly help you bring products to market that meets the requirements of regulatory agencies and also your customer needs. A quality management system (QMS) is defined as a set of comprehensive business procedures and processes that are designed to meet customer requirements and also create quality products. So, it is very important to ensure that the quality management system should be aligned with regulatory requirements.

Orcanos is the one such leading company that serve high-tech industry-leading companies and specializes in medical device manufacturers. Orcanos provides a continuous real-time audit for medical device and compliance medical device lifecycle management. Our holistic approach supports senior management, R&, and QA/RA. Orcanos Integrating design control software enables medical device manufacturers to provide documented evidence that a well defined and controlled product development and design process is in the right place and has been properly executed and manufactured. This collaborative design control software improves regulatory compliance and design quality through best tools that enable you to record and review design evidence and stay on top of the design history and key activities.

Orcanos Application Lifecycle Management (ALM) provides FMEA risk management, document management, requirements management, test management and quality management processes and procedures everything on a single respiratory. Orcanos requirements management tool is the one-stop affordable cloud solution for managing and tracking testing and requirements as part of Orcanos integrated ALM and QMS platform. One of the biggest advantages and the great power of Orcanos is in the integration between design control, quality, R&D and regulation. To know more details and information about Orcanos please visit our website here: https://www.orcanos.com/compliance/

Benefits of implementing the QMS

Companies that are involved in designing and manufacturing of any types of devices need to adopt the quality management system into their organization. As the name suggests, the quality management system is a set of policies and procedures aimed to make sure the right product quality.

Adopting the set of rules stated in the quality management system abbreviated as QMS helps to manufacture goods that are of the optimum quality and homogeneous.

Is there any standard available for QMS?

The basic standard has been set by ISO (International Organization for Standardization) in the ISO 9001:2015. It specifies in detail what the scope of the QMS Quality Management System is. All the companies, industries, and factories must adopt to these sets of rules for meeting the standards set by the ISO.

QMS is a very broad concept and so there are other series of ISO standards that focus on certain aspects of QMS. The ISO 14000 series is improving environmental management systems, ISO 13485 for maintaining QMS for medical devices, ISO 19011 audit management systems, etc.

There are many benefits of implementing the ISO.

It helps to meet the requirement of your customers and clients. This gives confidence to the customer that your product is safe to use and thus they eventually become hooked to your set of products.

It ensures making the best quality products at the optimum cost. Thus adopting the ISO is beneficial for cost-cutting and improving profit and revenues.

It helps to identify, define and improve the process involved in manufacturing and designing

It makes sure that there are no mistakes during the product manufacturing process and all the products are alike.

Adopting the QMS also helps in reducing wastes as you have to deal with wastes properly.

Lowering the cost associated with manufacturing goods.

Providing proper training to the staff so that they become efficient workers.

Being consistent in delivering the results.

What are the different elements or levels in a QMS?

Manufacturing of goods is a big process that can be subdivided based on the category of work they do. QMS tries to implement the rules for each of these processes. These elements are-

The policy of an organization and its quality meeting objectives

Quality manual

Procedures and instructions

Managing data

Internal process

Quality analysis of the products

Introducing and implementing the QMS in your manufacturing process

The steps to implement QMS can be divided into 7 steps as follows-

Designing the product according to standards

Manufacturing the product

Testing the product before release so that it meets quality standards

Correcting the flaws of the product

Improving the entire process for better efficiency

If you want to implement QMS for medical devices and need help then you can visit the Orcanos website. It will provide you with integrated solutions for implementing QMS easily. For more information about please, visit https://www.orcanos.com/compliance/

#QMS System

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/

#Requirements Management Software

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/

Trending Blogs

Recently Viewed Blogs

Orcanos Software