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How can you employ the medical device CAPA best practices in your bug tracking?

May 5th, 2020 Posted by ALM 2.0, CAPA, Defect Tracking, Software Lifecycle Management 0 thoughts on “How can you employ the medical device CAPA best practices in your bug tracking?”

How can you apply some of the best practices of a medical device in your non-regulated product? And does it worth the efforts?

In this post, I will describe just a small tweak in your bug form, that will make a huge difference in your bug management and the quality of your product, with just a small tweak of adding “Root Cause” field to your bug form. 

Why? 

It will make your team THINK. Check it out

What is CAPA

A CAPA stands for  Corrective And Preventive Actions. To make it short – when something bad happens – you are supposed to do some investigation, understand the root cause of what happened, when, why, and come up with a plan of what you need to do in order to fix (Corrective) and to prevent it in the future (Preventive).

Adding Root Cause

Well, there is plenty you can do. But as I said, in this article, I would only discuss a small tweak: Add “Root Cause” field to you bug form

Why?

Because it will force your team to THINK. That’s it, no more. And when they think – this is when you start digging gold

Orcanos use case

I will explain using a true use case of Orcanos

 

Root cause starts with an investigation

 

We got a timeout message for our dynamic filter. It happened to one of our customers, so you can imagine, it didn’t look too good…as we had to deliver a quick fix.

A bug was reported and fixed, but the root cause field, which is mandatory inOrcanos, said something like “Problem in the query”. So we started an investigation to dig the REAL root cause.

 

The developer says “It was due to a wrong query to the database”, we ask: WHY? Why did it happen? “Well, It happened because we fixed the filtering mechanism, and the original query didn’t fit”. Oh really? Tell me more. “We have changed the filtering mechanism but didn’t change it in all the places we use this filtering mechanism, such as the dynamic filter”

Why?

Because…well, this is a sensitive area, and I was under pressure to deliver and didn’t have the time to go to all places and fix it. It would require lots of testing, and put us in high risk…”
So…Are there more places to check?

“Well…yes…but it only happens when the response has thousands of records…”

So, it will continue to happen, and if I understand correctly, we might have an issue in more places

“..we need to check…”

The decision was NOT GOOD since the problem was not fully resolved

But – the decision was GOOD in terms of reducing risk in a frozen environment and affecting more customers, as this rarely happened

 

So what could you do better?

“Well, I could fix the bug for immediate resolution, and raise another bug, or task for an overall fix in the next release, I guess…”

 

It goes and on for more corrective and preventive actions, changing our working instructions, and emphasis these topics on our weekly meetings. 

All because of one investigation. 

So you see, It’s more of a state of mind than a technical stuff

Conclusion

See that sometimes the root cause can reveal much more than just a code mistake. It teaches you about how your team thinks, and what drives them in their decision making, sometimes without seeing the big picture. 

These investigations make them and you to think in a wider scope and become EXCELLENT!

10 Tips on How To Keep Your Good Manufacturing Practice and Making GMP At Top

July 29th, 2019 Posted by e-GMP, Software Lifecycle Management 0 thoughts on “10 Tips on How To Keep Your Good Manufacturing Practice and Making GMP At Top”

OVERVIEW

GMP is all about manufacturing safe, and high product quality.

On a recent audit I participated in, for one of our customers, the auditor stated the tremendous effort small companies will have to invest in order to meet regulatory compliance in the next 2-5 years.

It was mind-blowing and drove me to write this article, and share with you some tips on how to keep your GMP at the top.

What is GMP

The GMP establishes minimum standards for product manufacturing, to assist in preventing adulteration. But more importantly, GMP needs to be a so-called “lifestyle” that each company clearly defines and implements through its quality systems, in order to protect the safety of its customers.

The 10 principles of the GMP

These are 10 principles of good manufacturing principles that I believe can help in achieving a “GMP lifestyle” in your organization.

1)    Writing step-by-step procedures and work instructions

2)   Carefully following written procedures and instructions to prevent contamination, mix-up, and errors. [Many recalls on these topics were issued during 2019].

3)   Promptly and accurately document work using Document Management System preferred electronic DMS for a better tacking, sign-off and traceability [You can read here about Orcanos Document Management System]

4)   Providing evidence that our QMS does what it is designed to do by validating our work by preparing a [master validation plan]

5)   Integrating productivity, product quality, and employee safety into the design and construction of our facilities and equipment.

6)   Properly maintaining our facilities and equipment.

7)   Clearly defining and demonstrating job confidence.

8)   Protecting our products against contamination, by making cleanliness and hygiene a daily habit.

9)   Building quality into our product by systematically controlling our components and product-related processes, such as manufacturing, packaging, labeling, testing, distribution, and marketing.

10)   Conducting planned and periodic audits for compliance and performance [Learn about Orcanos Audit Management System].

 

These 10 principles of GMP, provide us with a framework for building and maintaining a GMP lifestyle and help us evaluate how well we are complying with the standards of good manufacturing practices.

Procedures and working instructions

The first two GMP principles stress the importance of written procedures. The best way to comply with GMP is to have well-written procedures and to carefully follow them.

The heart of GMP is the establishment of well-written procedures for each operation. These written procedures give us the controls necessary to minimize the chance of mix-ups and errors in manufacturing a product. When we carefully follow our written procedures, we not only ensure compliance with the GMP regulation but more importantly, we ensure the consistent quality of our products.

Fig 1: Manage a CAPA in Orcanos eQMS™

Validating our work

The next two GMP principles stress the need for us to document and validate our work. Because documentation and validation are so important to us and to our company, let’s look at them more closely.

 

We may begin by asking, what does documentation really mean, in terms of our job performance? Well, documentation requires a specific action on our part. The recording of each significant step we perform as we perform a job task. Documentation should be made properly and accurately, and in accordance with our written procedures.

 

As important as documentation is, it shows only that we have carefully and exactly followed our written procedures. Validation is proactive proof that we can produce safe and effective products. Validation requires a series of tests to assure that our systems and processes do what we say they do. We must be sure our production processes consistently meet the specifications our company has established. Therefore validation gives meaning to the documented records we keep. It is validation that tells us that our written procedures are correct, and that our products are truly safe and effective.

Facilities and equipment management

GMP principles fifth and sixth focus on the design, construction, and maintenance of our facilities and equipment. Let’s take a look at how GMP relates to the place where we work, and the equipment we use.

 

Our key concern is to avoid the possibility of contamination, mix-up, and errors in our workplace. For example, we keep certain areas, the cafeteria, locker room, and washrooms, separated from the manufacturing area. Where necessary to protect the integrity of our products, we carefully control water, air, temperature, and humidity. Housekeeping, sanitation, and maintenance also work to defend against contamination, mix-ups, and errors.

The right people

The seventh GMP principle states that good manufacturing practice requires competent people. People who can do the job right, the first time and every time. That means it is our personal responsibility to develop, demonstrate and continuously improve our job competence.

In order to do any job well, we must be properly trained; and this is particularly true in the manufacturing and quality control areas. In fact, our company must have a formal training program, to ensure that each employee can competently perform assigned job responsibilities. And that leads to our eighth GMP principle, which focuses on cleanliness, and requires us to be constantly on guard to defend our products against contamination.

Fig 3: Example of a training program template

Contamination

Contamination can be a powerful and dangerous enemy, which takes on many different forms. One of the most common forms is Particulate Contamination. This simply means that a product has been made impure by any particle that doesn’t belong in it. For example, dust, lint, fibers, and hair are all potential causes of Particulate Contamination. That is why, we must be properly dressed to prevent contamination when working with our materials, component, and products.

The second kind of contamination is Microbial Contamination. This is caused by microscopic organisms, known as microbes. Microbes are living organisms that exist one everything in the environment that has not been sterilized. Microbes include fungus,  mold, bacteria, and viruses.

The third form of contamination is Cross Contamination. Cross Contamination occurs when traces of other materials’ components and products adulterate or mis-brand the products we are currently manufacturing, packaging or testing. So it is critical that we practice good personal hygiene, and help keep our workplace clean by reporting any condition or practice in our plant, or with our equipment that might be a potential source of Particulate, Microbial or Cross Contamination.

Quality Management

The ninth GMP principle focused our attention on the importance of building quality into our products, by systematically controlling our components and product-related processes. To see how GMP helps us build quality, let’s examine the critical areas where we must establish effective controls. Materials and components present the first critical control challenge. We must be sure all of our components and materials satisfy our quality standards. Upon receipt, they must be carefully examined for damage and contamination, properly identified and tagged, and stored in a quarantine area. Where required, certain components and materials must be sampled and tested to ensure they meet established standards of identity, quality, and purity. Only after approval is they released to manufacturing and used on a first-in-first-out basis. That is, the first materials and components approved for release, are the first to go to manufacturing.

The second critical area we must control is the manufacturing process itself. To ensure quality and uniformity of each product, we have master records that outline the specifications and manufacturing procedures, and individual batch or history records (E-DHR) to help us document our conformance to the master record, and written schedules and procedures for cleaning and maintaining our equipment. To help us operate in a state of control, we carefully follow written work instructions, accurately collect critical data, and promptly document manufacturing results.

Fig 4: Production ATE Results Online Collection (GMP)

Fig 4: Production ATE Results Online Collection using Orcanos Rest API

Packaging and labeling is the third critical area where we control for quality. We must inspect the packaging and labeling area before each new batch or lot is processed; to help us be certain that the packaging equipment is clean and that the area does not contain any packaging or labeling materials from a previous run.

 

The fourth critical area is testing and supports all other areas of control. How we handle incoming, in-process and finished product test samples, how we perform test methods, how we document test results, are all significant elements of the testing process, and must be performed by qualified individuals.

Fig 5: Test Protocols Results using QPack Test Management™

Fig 5: Test Protocols Results using Orcanos Test Management™

Safety

The final critical area of control focuses on how we assure the safety, effectiveness, and purity of our product, as they enter the marketplace. The challenge to control the quality does not end when the finished product is tested and released. We must carefully control the product as we warehouse and distribute it to our customers. We must closely monitor the sales and marketing strategies we use to interact with our customers, and we must keep accurate records to provide product traceability, and promptly respond to any customer problems, concerns or complaints.

Fig 6: Follow Up Global Activity on Service Call using QPack Service Center

Fig 6: Follow Up Global Activity on Service Call using Orcanos Service Center

Audit

The tenth and final GMP principle entail the need to continually audit our day-to-day job performance, and verify that we are in compliance with the GMP regulation. The FDA has a major responsibility to externally audit our manufacturing operations, to see if we are in compliance with the GMP regulation. But it is our company’s responsibility to internally ensure the integrity of our products. And most importantly, it is our personal responsibility to evaluate how well we are living up to the standards of GMP. By performing a self-audit, using the 10 principles of GMP, you can make GMP a daily lifestyle in our company, and not just regulation.

Fig 7: Proactive Pre-Audit Reports/Alerts using QPack Reporting Tools

Fig 7: Proactive Pre-Audit Reports/Alerts using Orcanos Reporting Tools

 

In addition to our responsibilities to our customers, the FDA also has a responsibility to protect the consumer. In fact, the FDA can recommend a recall, if they find one of our products contaminated, mislabeled or if our product is not manufactured in compliance with the current GMP regulation.

Summary

So it is extremely important that we carefully follow the 10 principles of GMP. At our company, we are all concerned about what we do, and how we do it. This concern for quality, helps us earn the trust of millions of people who use our products. It is our job to make GMP a lifestyle, and live the principles of GMP each and every day.

Related Links

Orcanos Integration with Zapier – September 2017

August 7th, 2017 Posted by Software Lifecycle Management 0 thoughts on “Orcanos Integration with Zapier – September 2017”

We’re really excited to announce our coming integration with Zapier, which brings the full power of Orcanos to more than 750 applications. You will be able to easily link Orcanos work items such as defects, requirements, and tasks to Jira, Google Sheets, Github, Salesforce, Slack and many other apps, and trigger actions on specific events such as work item update in your Orcanos account, test fails, new discussion, etc.

No programming skills required!

What is Zapier

Zapier is a popular website that allows you to easily connect two apps (or web services) together and send data between them, by creating some really convenient flow automation, called “zaps”. Zapier currently supports over 750 different web services and apps. You can open a free account to start with, and create your first ZAP within minutes.

Zapier allows you to define Actions and triggers.

  • Actions – such as Add/update work item in Orcanos on 3rd party app triggers
  • Triggers – such as work items added or updated in Orcanos will trigger actions on 3r party apps in Zapier

Each integration is called ZAP, and you can define multiple ZAPS.

Zap example: On each bug creation in Orcanos – add a bug in Jira

Orcanos ALM Integration

So, mostly the Orcanos-Zapier ALM integrations will focus on other ALM tools such as Jira, Team Foundation Server, etc..

As Orcanos provides an All-in-one ALM and Quality Management repository, it provides everything for the R&D team. But for those who don’t use Orcanos, the ALM integrating with commonly used tools like Jira, makes Orcanos ALM much more powerful. It enables combining regulated tasks related to quality management, electronic signatures, document control and so on, with non-regulated tasks such as development tasks, Agile SCRUM, etc.

Try to create Zap Application from above link and let us know if you need any support to do create your first ZAP.

Tip Of The Week – RISKs To Protect Your Medical Device From the Next Cyber Security Attack

July 9th, 2017 Posted by Software Lifecycle Management 0 thoughts on “Tip Of The Week – RISKs To Protect Your Medical Device From the Next Cyber Security Attack”

 

Author: Rami Azulay | Master ALM for Medical Device

In this article we have compiled a set of RISKs that you may want to consider in your RMF file, to better protect your medical device from future Cyber Security attacks. While the 2017 data is still sketchy, we can determine that security hacks of electronic medical records have more than doubled in 2015, costing the healthcare system at least $50 billion. This information is as per a new report from the American Action Forum. Recent 2017 cyber security attacks have not surpassed health care systems, and so we must address  how we should handle  such breaches.

It is our goal at ORCANOS to address health care systems security. We are seeking to come up with true practical actions that can be performed by any medical device vendor. Through  our ORCANOS | RISK management system, you can address cyber security events that are related to medical devices. This system is now available for you on our evaluation system;  you may  register on our web site www.orcanos.com.

A RISK based approach is the best way for any medical device vendor to both analyse  and mitigate cyber security breaches. The RISK system also forces the vendor to walk through the device design analysis so as to understand possibilities for security breaches.

In this post, the RISK based process is shortened for you, and we update you on  recent cyber attacks, as well as suggest how you can  handle them; based on  your device. The full list of RISKs on our evaluation system is available for FREE.

Electronic Health Record Systems

The most widely attacked systems at this time, are Electronic Health Record (EHR) systems. These attacks are not EHR specific, but impact other systems that are connected to the EHR. While the adoption of EHR systems promises tremendous benefits, including better care and decreased healthcare costs; serious unintended consequences from the implementation of these systems have emerged. Why is healthcare data such a target?  For one, data indicate that health care information is worth 10 to 20 times more than credit cards information on the black market (selling for at least $10 each). Additionally, medical information compared to credit card fraud, can be used in different ways – to access bank accounts, defraud insurers and governments, and obtain prescriptions.

So here are 4 ways to control this risk.

 

Electronic health records can be compromised

Hazard Cause Of Failure Effect Of Failure Risk Control
Electronic health records can be compromised
  • Have been developed from erroneous or incomplete design specifications;
  • Be dependent on unreliable hardware or software platforms;
  • Have programming errors or bugs;
  • Work well in one context or organization, but be unsafe or fail in another;
  • Change how clinicians do their daily work, thus introducing new potential failure modes.
Impact of Electronic Health Record Systems on Information Integrity: Quality and Safety Implications
  • Inoculate system by encrypting data-at-rest
  • Conduct an annual HIPAA security risk analysis
  • Conduct more frequent vulnerability assessments and penetration testing
  • Invest in the security awareness of your workforce

Pacemakers or insulin pumps vulnerability to high profile attacks

The recent introduction of Internet Of Things (IOT) into  medical device softwares, has  significantly exposed them to potential cyber attacks. One  case study discusses  an attack on of a “smart” insulin pump. According to the study, a hacker  could  kill the patient by ordering an insulin injection when none was needed. So-called “smart” devices are notoriously weak  when it comes to digital security. We have  seen too many high profile cases where  significant preventable damage was done. Equipment manufacturers often can’t be bothered to insert  reasonable security measures into the equipment they sell. This  means that  if your device is in some way connected to a network, it is critical that you ensure that access to your device is only possible by authorized personnel, and that your communication protocols are all encrypted or scrambled to the highest security network layer.

Pacemakers or insulin pumps vulnerability to high profile attacks

 

Hazard Cause Of Failure Effect Of Failure Risk Control
Pacemakers or insulin pumps vulnerability to high profile attacks There are ways for a hacker to spoof communications between the remote control and the insulin pump Potentially forcing the pump to deliver unauthorized insulin injections Those communications needs to be encrypted, or scrambled, to prevent hackers from gaining access to the device

There are far more  RISKs we would like you to know about, which can  help you improve existing security, protecting your device from the next cybersecurity attack.  Over the past 12 years, ORCANOS has gathered intelligence and experience to provide you with the best system to manage security RISKs. Go ahead and register today for your FREE 30 days evaluation system.

 

 

Sources:

 

Real Imaging Customer Story

June 26th, 2017 Posted by Software Lifecycle Management 0 thoughts on “Real Imaging Customer Story”

Real Imaging Product

 

Quality is an Accelerator: How Combined Modern ALM and QMS Software Speeds Up Product Development

June 6th, 2017 Posted by Software Lifecycle Management 0 thoughts on “Quality is an Accelerator: How Combined Modern ALM and QMS Software Speeds Up Product Development”

By: Rami Azulay | ALM Master at ORCANOS

We are facing an ever-changing and increasingly complex medical device regulations, most companies I have been working with have built their compliance systems on risky paper-based quality systems as well their R&D legacy or in other cases general purpose software which is not built for med device.

Now is your chance to lead your organization to the next level. You can do better and we’ll can tell you how to do it by just spending 1 hour meeting with us. Go register now for free on http://www.orcanos.com/signup and ask from us to demo ORCANOS solution.

You already know by now that Inefficient systems increase your risk of noncompliance and increase your development time. That translates into your lake of ability to act quickly when quality event comes into your organization and to overwhelming spending of time and effort to manage that. In other cases we talk about missed sales opportunities and patients waiting longer for your new medical technologies.

So we’ll show you a modern, purpose-built software ORCANOS | MEDICAL that guide you step by step to ensures compliance with all the latest regulations to free up your engineers’ time, reduce risk, time to market, and help you pass audits with peaceful mind, since you know that you are under control..

In this one on one session, you can meet with ORCANOS. We’ll explain how innovative medical device manufacturers are leveraging modern R&D and QMS in one Software system to:

  • Accelerate product development efforts — from napkin idea using ORCANOS | ALM, to CE, 510K approval to market release months or years quicker
  • To Post Market support with end to end traceability between COMPLAINT to CAPA to ACTIONS to RESOLUTION back to the CUSTOMER with RISK mitigation.
  • Manage risk to drive the safety and quality of products and processes through QMS per ISO 13485:2016 & ISO 14971 and 21 CFR Part 820
  • Change their company’s focus from simply meeting regulations to building quality into their processes as a differentiator using real time compliance engine that measure your work against best practice quality KPI’s or your can design your own.
  • Understand and stay ahead of the FDA and EU changing quality regulations as leaders instead of followers using ORCANOS next gen Market Place (2018)

Setup time to meet with us by just register to our free evaluation on: http://www.orcanos.com/signup

 

ORCANOS | MEDICAL RISK Identification Announcement (05201701)

May 23rd, 2017 Posted by Software Lifecycle Management 0 thoughts on “ORCANOS | MEDICAL RISK Identification Announcement (05201701)”

SOURCE: Based on True Story

AUDIENCE: Risk Manager, Care Personal

ISSUE: In case the medical device is exposed to low frequency vibrations (rotating parts or motors) it may cause the pins within the internal cable that connects to essential parts of the device to become loose over time. The loose pins may prevent data to be transferred between the essential components of the device to the control board, triggering the device to shut down unexpectedly and/or to sound an alarm. An unexpected stop in device therapy may cause serious adverse health consequences, including death.

RECOMMENDATION:

  • Update training programs and perform actions to have appropriately trained personnel
  • Give failure probability estimation (Low/Med/High)
  • Ensure an alternative form of similar device is available at all times, including intra-hospital transport (e.g. manual transport bag).
  • Operate the device as directed in the operator’s manual including:
    • promptly attend all alarms presented by the device;
    • use an external replacement alternative, and to set the alarm thresholds appropriately;
    • ensure the correct circuits identified in the operator’s manual are being used;
  • When possible, connect the device to a remote call system.
  • List possible error codes and mitigation actions:
    • turn the device off
    • discontinue use of the device
    • use an alternate device
    • call your local customer service contact and report the failure by referencing.

CAPA:

On the preventive action you may consider change in the design of those connector and to reinforce the connectors by mechanical secured connection to prevent vibration impact on the connectors due to friction in the connectors pins.

ORCANOS | MEDICAL: Our recommendation with the use of ORCANOS | MEDICAL Risk management system is to include this risk identification in your RMF file managed by ORCANOS system and create traceability to:

  • DMS Item – Release new training program
  • Requirement Management – New design requirements to address the issue
  • RISK – Risk identification
  • V&V – Verification and Validation test protocols
  • e-DHR System – update working procedures as needed.
  • CAPA – Manage CAPA form and traceability to RISK and Complaint
  • ECO – Issue new ECO and trace all releases with the ECO

ORCANOS Deploys Google Material Design for Orcanos ALM 2017 UI / UX

November 18th, 2016 Posted by Software Lifecycle Management 0 thoughts on “ORCANOS Deploys Google Material Design for Orcanos ALM 2017 UI / UX”

All about our users…

ORCANOS GOAL

Comply with Google Material Design to create a visual language that synthesizes classic principles of good design with the innovation and possibility of technology and science

Well, in other words – we want to make our end user feel comfortable with Orcanos technology

Material is the metaphor

A material metaphor is the unifying theory of a rationalized space and a system of motion. The material is grounded in tactile reality, inspired by the study of paper and ink, yet technologically advanced and open to imagination and magic.

Surfaces and edges of the material provide visual cues that are grounded in reality. The use of familiar tactile attributes helps users quickly understand affordances. Yet the flexibility of the material creates new affordances that supercede those in the physical world, without breaking the rules of physics.

The fundamentals of light, surface, and movement are key to conveying how objects move, interact, and exist in space and in relation to each other. Realistic lighting shows seams, divides space, and indicates moving parts.

Ref: From Google Material Design

ON-BOARDING WIZARD

To get new users up and running quickly is a real challenge. Orcanos invested in building on-boarding wizard, that based on industry sector and needs, provides templates and how-to’s to start with. These templates are based on Orcanos 12 year extensive experience with ALM and Quality procedures.

Right from the beginning, the on-boarding UI was detailed to assure user adoption and good experience.

orcanos software onboarding

 

MAIN SCREEN

Main screen colors & structure are adjusted in a way so user that spends hours in front of the computer would feel comfortable. So relaxing colors, minimize the controls on each screen

orcanos-medical-main-screen-adaptive-alm

ORCANOS ALM DESIGN CONSIDERATIONS

COLOR PALLET

Material takes cues from contemporary architecture, road signs, pavement marking tape, and athletic courts. Color should be unexpected and vibrant.

This color palette comprises primary and accent colors that can be used for illustration or to develop your brand colors. They’ve been designed to work harmoniously with each other. The color palette starts with primary colors and fills in the spectrum to create a complete and usable palette for Android, Web, and iOS. Google suggests using the 500 colors as the primary colors in your app and the other colors as accents colors.

Themes enable consistent app styling through surface shades, shadow depth, and ink opacity.

orcanos software dashboard colors

SPACING

Just so not everything is squeezed too much…lot of space is “lost” so user is not overwhelm with information

orcanos dashboard spaces

CSS RATHER THAN IMAGES

UI styling is based on CSS files rather than images to make Orcanos faster and robust

orcanos-css

Every pixel counts…

orcanos-pixle

ICONS

Minimize number of icons, colors

orcanos software - icons

SCREEN BEHAVIOR

Define scrollable area so user remains on the same position always

orcanos-google-material-design-scrollable-area

USABLE FEATURES

TRACEABILITY TOOL

orcanos-traceability-tool

WORK ITEMS – LIST VIEWS

Spacious list views, floating buttons

orcanos software - work items

 

INSTANT MESSAGING, ONLINE CHAT

orcanos-instant-messaging

 

STARRED ITEM

orcanos-manage-starred-items

 

FIND YOUR INFORMATION

Easily get your data using Orcanos tools:

Product tree, Search, Starred items list, Recent items list, Deleted item list

orcanos-search

Dashboard panels

orcanos-medical-main-screen-adaptive-alm

List views

orcanos software - work items

Easily navigate through work items path

orcanos-navigation

USER MODE: COMFORTABLE, COZY AND COMPACT LAYOUT

If user prefers to have less spaces, he can easily switch from Comfortable mode to Cozy or Compact

orcanos-layout

 

MAIN MENU

All modules are accessible within one click

ALM (Product tree), Document Control (QMS), Service Center and e-sign (part 11)

orcanos-modules

 

PROFESSIONAL TOOLS FOR EACH MODULE

ALM

Manage products, projects hierarchically, using Orcanos work items and traceability tool

orcanos-alm

FMEA RISK MANAGEMENT (ISO 14971)

Setup your FMEA Risk Management according your SOP within minutes

orcanos-fmea-risk-management-iso-14971

CUSTOMER FACING

Orcanos service center to manage customer service calls, and trace them back to R&D or Quality Control

orcanos-service-center

DOCUMENT CONTROL

Hierarchic and intuitive Document Control, fully 21 CFR Part 11 compliant

orcanos-document-control

 

TEST MANAGEMENT

Simple and powerful test management tool, as part of Orcanos ALM system

orcanos-test-management

 

SIMPLE AND POWERFUL ADMIN TOOLS

Creating projects, users, permissions and system settings and customization was never so easy

orcanos-admin

 

MOBILE ADAPTIVE

orcanos-mobile-adaptive

ORCANOS revamps user interface with a new Google Material Design experience

October 26th, 2016 Posted by Software Lifecycle Management 0 thoughts on “ORCANOS revamps user interface with a new Google Material Design experience”

ORCANOS revamps user interface with a new Google Material Design experience, to support its 2017 Adaptive ALM Platform

Rarely that a software company gets an opportunity to work on something that is a game changer. Something risky but meaningful. So we are now presenting for the first time Orcanos Adaptive ALM Platform.

orcanos-alm-ui-ux

ORCANOS is a leading provider in ALM and quality control, serving clients around the globe, and expertise in medical device. Understanding the particular needs of our customers is essential for a bootstrap organization, attempting to contend with huge ALM vendors.

So, for the question what do our clients need, we concluded that they need a modern, and clean user interface, and ONE STOP SHOP to manage their R&D/QA/RA activities.

ALM is one stop shop for R&D, but what about Quality? what about regulation? and how can one system manage everything in one place? and make it simple enough for the end user, that can be anyone from executive, developer, QA/RA or a tester?

And one more thing. There is no such thing as a generic, one-size ALM. Companies are different. testing, quality procedures and regulations requirements are different in each sector. This is why Orcanos came up with the Adaptive ALM platform.

It doesn’t matter if our customer is a 3 people startup developing the next medical device prototype in their garage, or a well established organisation, with well-established R&D department and quality procedures.

So after listening, studying, and getting all of the feedback, Orcanos put together a completely new ALM experience that is going to accelerate adoption of our users, submit to their industries or sectors. And we’re talking about a completely new user experience, not just colors and fonts tweaks.

Orcanos Adaptive ALM Cloud solution is available for evaluation and pilot starting January 2017, and is expected to be generally available in April 2017.

Meet ORCANOS at the MediTech 2016

October 13th, 2016 Posted by Software Lifecycle Management 0 thoughts on “Meet ORCANOS at the MediTech 2016”

Come and meet ORCANOS @ Booth 38

On November 22, 2016, ORCANOS the ALM company will be hosting an Open Booth dedicated to the ORCANOS MEDICAL solution, ORCANOS MEDICAL the ALM solution for Medical vendors, featuring live, private demonstrations the use of advanced tools that allow to preserve the information gained through the ATE systems intelligently and efficiently.

Free Entrance (Registration Required)


meditech-22-11-2016

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