Orcanos QMS: Regulation Compliance & Governance Engine

August 7th, 2017 Posted by Document control, IEC 62304, IEC60601, ISO 13485, ISO 14971, regulation compliance 0 thoughts on “Orcanos QMS: Regulation Compliance & Governance Engine”

Orcanos is about to launch its QMS-Regulation-Compliance engine as part of Orcanos integrated ALM and Quality Management Software System.

Abstract

Compliance best practices lie at the heart of all standards-based regulations and good quality management, such as ISO 14971, IEC 62304 and ISO 13485. However, it is a challenge to keep compliance without electronic QMS, or using traditional ALM tools, as most of them are R&D driven, and lack the support of the quality management software system. Compliance remains a leading concern for regulated industries such as Medical Device, Pharma and automotive.

Orcanos QMS Compliance engine

The powerful new capabilities of Orcanos Compliance Engine would simplify the way companies govern and control quality and regulations, and will provide a “Virtual Auditor” that would scan the project data in respect for specific industry regulation, and quality best practice, such as compliance with ISO 14971, IEC 62304 and ISO 13485 and more.

Orcanos QMS Compliance Engine is a flexible tool that allows companies define any regulation in a simple Excel or Google Sheet, defining the standard, section, classification in case of medical device (CLASS I, II, III), Remediation, and many other parameters, ans then import these regulations into Orcanos ALM and QMS platform and connect it to their projects records.

Orcanos QMS Compliance Engine then scans project data based on the specific regulations, and specific logic attached to it, and shows the faults in a graphical presentation. Together with Orcanos dashboard and notification mechanism we provide quite a good control and monitoring platform

Defining a compliance audit item

Define any compliance audit, setup and customize each compliance item

Compliance Audit

Running a compliance audit check

This is an example of an “Virtual Auditor” that inspects the compliance of specific product with the ISO 14971.

Running Compliance Audit Check

 

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

Tip of The Week – How You Can Be The Best Recall Specialist

April 26th, 2017 Posted by 21 CFR Part 11, ISO 13485, Recall, Services, Tip Of The Week 0 thoughts on “Tip of The Week – How You Can Be The Best Recall Specialist”

Recall Specialist – Medical Devices

Author: Rami Azulay (ALM/Medical Specialist at ORCANOS)

Are you eager  to join an innovative organisation? Do you want to play an integral role   helping clinicians improve  healthcare outcomes for patients? Have you always wanted to join a driven, entrepreneurial organisation that promotes from within? Then your ideal role is that of a Recall Specialist!

As a Recall Specialist, you will be required to provide Product Field Action, which means you will given direct access to all product design documents and verification, and validation protocols in order to perform effective  investigations. You will need access to both production and  manufacturing evidence documents on the device performance during production and  methods which support  the QC process. You will need access to the reporting entity so as to be able  to collect missing information needed to execute your CAPA process and of course, access to the support groups on Tier 1, 2, 3 and 4. These tiers support and manage a diverse range of medical devices. These tasks are only able to be carried out  through a collaborative working environment; not just in the human resource level, but also between the tools and repositories that hold that information.

The key duties of the recall specialist include: The regular reporting, follow-up and processing of regulatory actions, which require more time outside of your day to day tasks. While tools such as ORCANOS | MEDICAL system can provide you with proactive notifications based on Artificial Intelligence (AI) built into the system that compare your execution activity with the regulation and compliance to your organization standard operational procedure (SOP).  This will involve actioning on all aspects of Product Hold (PH) and Product Field Actions (PFA), and enacting the Universal Recall Procedure (Post Market Surveillance) to ensure the appropriate maintenance or removal of nonconforming products from the marketplace. Again ORCANOS | MEDICAL includes with the same system a Post Market Surveillance system call ORCANOS | SERVICE CENTER which act as gateway between the market to the manufacture or the distributor. It allows secured data communication between all parties, of course the AI system will cover regular reporting and follow up on actions, on that same system as well.

It is preferred that the Recall Specialist hold a tertiary science/engineering degree or equivalent. Such academic knowledge coupled with access to relevant and accurate information adds to the effectiveness of the Recall Specialist. ORCANOS Cloud based system, which is validated and 21 CRF Part 11 compliant, makes the world a much smaller place. Information that is needed is easily accessible  from anywhere – either from the event area (if you need to travel for investigation), or from your office where you communicate with other professionals, and information needs to be  secured as you work on  a quality event.

Having a single tool that can manage  all these activities R&D->Quality->Manufacturing->Support in one place, reduces lessens the learning curve for the recall specialist who has to be acquainted with multiple systems, reduces the cost of licensing which   enables access to  secured information needed to work efficiently. .

This role provides an exciting opportunity acting in the center of all things, using advanced tools and methods that can guide and protect the organization interest which will follow by constant recognition for creating a positive workplace environment. If you are looking to take your career within QA and post market to the next level this could a sure way to go.

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

Tip Of The Week – What is Significant Software Change in Medical Device?

October 13th, 2016 Posted by Software Lifecycle Management 0 thoughts on “Tip Of The Week – What is Significant Software Change in Medical Device?”

Changes to Software

 

Many changes to a device’s software will require a licence amendment application. As software developer you may need to answer some criteria by the QA. The following may help you getting those answers right and at all times keep the patient safety protected by misselaineous  behaviour of the device.

The following would be considered significant changes:

  • a software change, which impacts the control of the device, that may alter the diagnosis or therapy delivered to the patient;
  • an alteration in software that modifies an algorithm impacting the diagnosis or therapy delivered;
  • a software change that impacts the way data is read or interpreted by the user, such that the treatment or diagnosis of the patient may be altered when compared to the previous version of the software;
  • a software change that replaces previously required user input a closed loop decision;
  • addition of a new feature to the software that may change the diagnosis or therapy delivered to the patient;
  • introduction to or removal of a new alarm function from the software such that a response to the new configuration may change the treatment of the patient in comparison to the previous version of the software;
  • a software change that incorporates a change to the operating system on which the software runs.

If the software is modified to correct an error (for example, a change in algorithm), for which there is a safety risk to the patient if the error is not corrected, this software change may require a licence amendment application. In such instances and where the software change is a corrective or preventative action for a recall, consultation with the Medical Devices Bureau is recommended to determine if the change requires a licence amendment application.

If a software change is only intended to correct an inadvertent logic error that does not pose a safety risk and brings the system back into specification, this is not a significant change.

Guidance for the Interpretation of Significant Change (Based on Health Canada)

The following would not be considered significant changes:

  • a software change that only introduces non-therapeutic and/or non-diagnostic features such as printing, faxing, improved image clarity, reporting format or additional language support;
  • a software change that only modifies the appearance of the user interface with negligible risk of impacting the diagnosis or therapy delivered to the patient;
  • a software change that disables a feature that does not interact with other features.

ORCANOS ALM Method

ORCANOS ALM system control change in software in two levels.

  • Major Change
  • Patch Change

Major change as indicated above will cause the ALM process to go into larger cycle of assessments, evaluations, verification and validation. In order to reflect such major change in the software you have in ORCANOS ALM, tools that allows you to control those changes and reflect them in your reports.

ORCANOS ALM system control each software work item by having 4 digits numbers reflecting the software version

Major.Minor.Release.Build

Major.Minor – The use of baseline in ORCANOS ALM allows you to capture changes in the scope of the Major.Minor view. So if you have change made within the baseline view the system will audit log the changes but will not force you to break out from that baseline using the Branch operation. Advancing a view to a new baseline will perform automatically some operations such as reflecting all historical changes on the newly created view and reset all test verification results back to stage 0 where tests will need to be executed and log results on the newly created view.

Release.Build – When a patch is required to be release, as considered as none significant change, the ORCANOS ALM system provides an easy way to contioue document those changes without the needs to branch out from the main view. Such changes will allow capturing those non significant changes and trace out the impact and plan needs to be performed.

 

Baseline Version Management on Orcanos  -  ALM - New Page

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