Orcanos to participate in Medtec Europe, Germany on 17-19 of April

February 13th, 2018 Posted by Events 0 thoughts on “Orcanos to participate in Medtec Europe, Germany on 17-19 of April”

Medtec

Medtec Europe 2018 _ New Medical Technology Device Events & Exhibitions

We are pleased to announce that Orcanos will participate in this year’s Medtec Europe taking place at Messe Stuttgart, Germany, 17 – 19 April 2018.

Medtec Europe is the event for global medical device manufacturers bringing together over 6,800 medical technology professionals from 76 countries around the world to source technology, networking, and innovation.
The show gathers leading medical device companies and advanced technology providers to discuss and share the latest product developments, research, and innovations in healthcare.

The show also hosts medical device service providers, such as Orcanos. We wish to share the significant contribution to the medical device industry and the impact Orcanos has on quality and R&D improvements.

We are looking forward to meeting with professionals from the medical device industry and to introduce them to Orcanos, and in detail our innovative and intuitive system Orcanos Medical, that provides professional tools such as requirements management tool, ALM Tools, and Electronic Quality Management System.
We will demonstrate how Orcanos will adapt to your company’s workflow and documents management, and how simple and intuitive the system is.

Come and visit us at our booth 9-B19!

To schedule a demo, kindly contact Mr. Rami Azulay, VP Marketing and Sales at rami.azulay@orcanos.com or
Mr. Henk van den Brink, Orcanos International Partner, at henk@persistency.nl

Be a step ahead and start using the Orcanos FREE TRIAL even before meeting with us!

 

 

 

 

 

 

 

 

 

 

 

 

פניה אישית למחזיקים במאגרי מידע בישראל

January 10th, 2018 Posted by Requirements Management Tool 0 thoughts on “פניה אישית למחזיקים במאגרי מידע בישראל”

ארגונים, חברות וגופים ציבוריים בישראל

חברת אורקנוס מזמינה אותך

להכיר את המערכת לניהול תהליכי יישום ובקרה של חוק אבטחת מידע  

מערכת איכות לניהול תקנות הגנת הפרטיות תשע”ז 2017

January 9th, 2018 Posted by Requirements Management Tool 0 thoughts on “מערכת איכות לניהול תקנות הגנת הפרטיות תשע”ז 2017”

דיווח על אירועי אבטחת מידע

הביקורת הנוכחית, של מבקר המדינה,  העלתה כי האסדרה הַתְּקֵפָה אינה מחייבת בעלים של מאגר מידע או גורם המחזיק בו לתעד את אירועי אבטחת המידע ואת הפעולות שננקטו בעקבותיהם. עוד העלתה הביקורת הנוכחית כי האסדרה הקיימת אינה מחייבת בעלים של מאגר מידע או גורם המחזיק בו לדווח על אירועי אבטחת מידע לרשם מאגרי המידע או לכל גוף מאסדר אחר ואף לא לאזרחים שמידע עליהם נחשף, ועקב כך הם עלולים להיפגע מהאירוע. במאי 2017 ,לאחר סיום הביקורת, פורסמו ברשומות תקנות הגנת הפרטיות , שייכנסו לתוקף במאי 2018 .תקנה 11 מחייבת 39( אבטחת מידע(, התשע”ז-2017 בעל מאגר מידע, בין היתר, לתעד אירועים המעוררים חשש לפגיעה בשלמות המידע, לשימוש בו ללא הרשאה או לחריגה מהרשאה ואת הפעולות שננקטו בעקבותיהם; לקבוע הוראות לעניין ההתמודדות עם אירועי אבטחת מידע, לפי חומרת האירוע ומידת רגישות המידע, לרבות לעניין ביטול הרשאות וצעדים מידיים אחרים שיש צורך בהם. אשר לדיווח על אירועי אבטחת מידע, בתקנה 11(ה-ו( נקבע כי בעל מאגר מידע חייב לדווח לרשם מאגרי המידע על אירוע 39 קובץ התקנות 7809( מאי 2017.) אבטחת מידע והגנת הפרטיות ברשויות המקומיות | 235 ראוי שמשרד הפנים ינחה את הרשויות המקומיות לדווח לו על כל אירוע אבטחת מידע, דבר שיאפשר לו לעקוב אחר היקף התופעה וליזום פעולות לצמצומה ועל הצעדים שנקט בעקבותיו. במקרה זה רשאי הרשם 40 אבטחת מידע חמור להורות לבעל המאגר, לאחר שנועץ בראש הרשות הלאומית להגנת הסייבר, להודיע על אירוע האבטחה למי שעלול להיפגע ממנו.

לאור ההתפתחות האחרונה אורקנוס פיתחה מערכת שתאפשר לרשויות להתמודד עם תהליך ההתארגנות ליישום התקן ולתהליך הבקרה שמתקיים לאחר מכן. מערכת אורקנוס תאפשר לפרוט את התקן באופן אלקטרוני ולעקוב אחר היישום של התקן בתוך האירגון. כל שינוי בתקן או ביישום ישחרר התראה לבעלי התפקידים ברשות ויצביע על ההשלכות של השינויים על תהליכי הבקרה.

כמו כן המערכת תאפשר לנהל את פיתוח הטכנולוגיות הדרושות כחלק מיישום התקן ולוודא שהיישום עונה על דרישות התקן דרך מערכת ניהול עקיבות חכמה. את מפרט הביקורות ניתן יהיה להגדיר לנהל ולבצע מתוך מערכת אורקנוס ולתעד את התוצאות של כל ביקורות באופן אלקטרוני מדוייק. מנמ”ר האירגון יקבל מערכת שליטה ובקרה בזמן אמת שתאפשר להציג את רמת האיכות של התהליך ושל מנגנוני הבקרה שלו.

   אורקנוס מיישמת מערכות איכות מזה 13 שנה בגופים רגולטורים כגון גונסון אנד גיונסון, גנרל אלקטריק, משרד הבינוי והשיכון, מדרוניקס, פלקסטרוניקס ורבות אחרות תוך הקפדה על עמידה באיכות מוצר גבוהה ופיתרון כולל קל ונוח ליישום. מערכת אורקנוס נבחנת מידי שנה על ידי מיטב גופי התקינה בארץ ובחו”ל בנהם מכון התקנים, רשות המזון והתרופות האמריקאית , מכון התקנים הקנדי ועוד רבים אחרים.

Orcanos

 

Automotive SPICE Standard V 3.0

January 5th, 2018 Posted by Requirements Management Tool 0 thoughts on “Automotive SPICE Standard V 3.0”

Automotive SPICE®
Process Reference Model
Process Assessment Model
Version 3.0

Process assessment is a disciplined evaluation of an organizational unit’s processes against a
process assessment model.
The Automotive SPICE process assessment model (PAM) is intended for use when performing
conformant assessments of the process capability on the development of embedded automotive
systems. It was developed in accordance with the requirements of ISO/IEC 33004.
Automotive SPICE has its own process reference model (PRM), which was developed based on the
Automotive SPICE process reference model 4.5. It was further developed and tailored considering
the specific needs of the automotive industry. If processes beyond the scope of Automotive SPICE
are needed, appropriate processes from other process reference models such as ISO/IEC 12207 or
ISO/IEC 15288 may be added based on the business needs of the organization.

http://www.automotivespice.com/fileadmin/software-download/Automotive_SPICE_PAM_30.pdf

ORCANOS released a new RISK management system ver. 3.0.0.135 (ISO 14971) based on 2017 recalls by the FDA

December 16th, 2017 Posted by ISO 13485, ISO 14971, Requirements Management Tool, RISK Assessment, Risk Management, Safety 0 thoughts on “ORCANOS released a new RISK management system ver. 3.0.0.135 (ISO 14971) based on 2017 recalls by the FDA”

ORCANOS released a new RISK management system (ISO 14971), based on recent RECALL CLASS 1 by the FDA, to include RISK analysis covering recent incident of potential flammability of battery used by the device. The new release includes also mitigation procedure for that case as well.

Hazard: Battery overheated on the device unit while charging in standby mode during a routine procedure

Failure Cause: Manufacturing Failure

Failure Effect/ Harm: System flammability causing fire or wrong function

Risk Control (RISK-2277): Register for the free trial on: https://lnkd.in/ghv8YX6

Please share with us more ideas on this topic.

 

Related Links

Risk Management

Quality Management

Document Control Software (ISO 13485)

What is ISO 14971

 

What we learned so far from our launch of ORCANOS Service Center

December 8th, 2017 Posted by ISO 13485, Tip Of The Week 0 thoughts on “What we learned so far from our launch of ORCANOS Service Center”

We are supporting our customers using ORCANOS Service Center, among other tools such as live chat. Live chats enable our business clients to access agents, who are skilled to answer questions customers may have, as they learn how to use our system.

Read More: https://www.linkedin.com/pulse/what-we-learned-so-far-from-our-launch-orcanos-service-rami-azulay/

WHITE PAPER ACHIEVING ISO 26262 COMPLIANCE WITH ORCANOS ALM and QMS

December 8th, 2017 Posted by ISO 14971, Risk Management, Validation and Verification 0 thoughts on “WHITE PAPER ACHIEVING ISO 26262 COMPLIANCE WITH ORCANOS ALM and QMS”

ISO 26262 is an automotive standard that places requirements on the quality of software, for which tools such as ORCANOS ALM and QMS are ideally positioned to enforce. With the highest adoption in the industry and a strong heritage in safety-critical applications, ORCANOS ALM and QMS have been certified as being “fit for purpose” to be used as tools by development teams wishing to achieve ISO 26262. This document describes the parts of the standard that are addressed by using ORCANOS ALM and QMS.

Read More: https://www.linkedin.com/pulse/achieving-iso-26262-compliance-orcanos-alm-qms-rami-azulay/?published=t

ORCANOS in MEDICA during 13 – 15 November 2017 in Düsseldorf

September 28th, 2017 Posted by Requirements Management Tool 0 thoughts on “ORCANOS in MEDICA during 13 – 15 November 2017 in Düsseldorf”

ORCANOS in MEDICA 2017

ORCANOS In Medica During 13 – 15 November 2017 In Düsseldorf

MEDICA is the world’s most significant event for the medical sector. For more than 40 years it has been firmly established on every expert’s calendar. There are many reasons why MEDICA is so unique, making it the largest medical trade fair in the world.

During the dates of 13 – 15 November 2017 ORCANOS will be present in the MEDICA event, ready to meet with you. Whether you are exhibiting or visiting we would like to meet with you. We can discuss the ORCANOS software solution for QMS and Product Development (ALM). To arrange a meeting with us contact: VP Sales & Marketing, Rami Azulay at rami.azulay@orcanos.com.

— Await you in Düsseldorf. Visit our website: www.orcanos.com

Try now!

Tip Of The Week – Common Faults A Document Controller Can Avoid

September 11th, 2017 Posted by 21 CFR Part 11, Collaboration, Document control, FDA, ISO 13485, Standards and Regulations, Tip Of The Week 0 thoughts on “Tip Of The Week – Common Faults A Document Controller Can Avoid”

Common Faults A Document Controller Can Avoid During The Document Control Process and Their Mitigation

 

OVERVIEW

Whether you are a  medical device vendor or function in another regulated field, the document control process is an essential part of successfully launching a product. You have the option of using an archaic filing system riddled with a minefield of human errors, or an automated electronic system. So if you are at the point where you are under a significant workload, and wish to have better compliance with the regulatory authorities, such as FDA, CE, it is time to consider an electronic document control management system, an e-DMS (Electronic Document Management System).

ISO 13485 section 4.2, describes the requirements which must be adhered to when producing documentation. Such documentation includes quality management manuals, procedures for approval, distribution, and change of a document and the designation of a person or persons who should implement those procedures. In the ISO13485 2016 edition,  specific procedures outline the prevention on of record loss, as printed documents filed using a traditional system, are at high risk of being lost. 21 CFR Part 820, is an essential regulation not only for medical device firms but for the food and pharma industry. For both, document control is an imperative.

ISO 13485

The ISO13485 2016 edition  (sections 3.2, 3.10, 6.2, etc.) is indicating both individual and corporate how to route documents in your document management system, for example, the following routing phases: document creation(draft), approval, rejection, change control, retrieval, and obsolescence.

According to FDA statistics, document control errors are frequent and numerous. Clinical trials indicate that many documents routed and logged, are inadequately documented and contain inaccurate case histories. These deficiencies make up the second most commonly cited FDA problems, and they rank fifth by the European Medicines Agency (EMA). In warning letters and audit observations, it was discovered that inadequate documentation impacted the thoroughness and level of care physicians can offer patients.   Poor document management is the direct result of paper documents, that can be easily misplaced.

In this article, I will discuss common issues which arise in every phase of the life cycle of a document. The information I will share comes out of my  25 years of experience developing ORCANOS Medical e-QMS  (Electronic Quality Management System) software solutions for regulated companies,  as well as my direct involvement in the implementation and deployment of ORCANOS Medical solution by quality professionals who are responsible for document control and quality management.

The 5 Routing States of the Document Control Process

 

Stage 1: Document Draft Creation

 

Problem #1: Collaboration is time-consuming.

Rarely one person is generating the document person, and almost always get approved and cycled over several stakeholders. Collaboration is normative during the initial phase of creating a document. This activity is time-consuming and can be rather costly. Bringing all stakeholders together in one room can also be impractical,  as relevant individuals are rarely in the same place at the same time. Additionally, the traditional method of routing a document via email is increasing the chance of conflicting edits.

Collaborative tools, such as Google Docs is an excellent way to cover some of the issues local office documents introduce. However, while Google Docs collaborators have the convenience of working together online, it does not resolve the critical obstacle of traceability. This approach requires extra work to approve and distribute these documents.

Our Suggestion for Collaboration

A Cloud-based document control system creates a virtual collaboration workspace. The workspace allows team members to add their files in a secure and real-time environment anywhere, anytime. The workspace gives global access to every employee, to add his/her document without having to wait for someone else to unlock the document. A cloud-based system not only allows access to authorized users 24 hours a day, but also eliminates the constraint of being in the physical location of the file, improves search capabilities and reporting, and allows Metadata definition for each file. DropBox, Google Drive or any other file sharing system are not supporting these capabilities.

ORCANOS e-DMS provides lot of capabilities, subjected to user privileges.

 Orcanos

Stage 2: Document Routing Process Approval and Distribution

 

Problem #2: Availability of personnel delays and grinds productivity to a halt.

People are not available. The process might involve executives who travel a lot. In the world of paper-based or hybrid process, there is a challenge to control or escalate a case where the approver missed its target. With an electronic system, you may have an alternate signer, who is authorized to replace the original signer (according to SOP). Also, such a system ensures that approvers do not misplace the right cell to sign on a printed document.

ORCANOS eDMS puts a due date for each document to sign, and fire an alert when the time is due.                       Image result for Availability

Problem #3: Misuse of revisions that are an obsolete revision.

The control on old document revisions is still a major challenge to QC and others departments. Once a new revision becomes effective, accessing older revision (which is now obsolete) should be forbidden, leaving only the last approved revision available for download. Using the obsolete revision of a procedure, drawing or specification is still the source of many errors. Lack of access to released documents, as well as difficulty in finding them, is often the result of staff making uncontrolled copies, either paper or electronic.

Problem #4: Training can fall through the cracks.

The cycle of approval of a quality document ends with distribution. There is a major challenge in notifying relevant stakeholders.

In such cases, it is needful to create traceability from the approved documents to training forms. Such training form needs to have a life cycle of its own, but it will be clear what action needs to take place in order to make the document effective.

ORCANOS e-Training module allows you to create these links easily. So for example, if new working instructions need to be deployed the working instruction documents must first be approved. You will next need to create a training form which specifies the audience who needs to participate in the training of the new working instructions and trace it back to the released document. As quality personnel, you will have all the information in one place, a system that will also notify when the training has completed. Ensuring that the appropriate people understand the change and are competent to perform the newly revised work instructions can be challenging for many organizations.

Our Suggestion for Mitigation:

In our 12 years of experience, we have found that companies reduce their review and approval turnaround time significantly after implementing ORCANOS e-DMS process. Routing, follow-up, escalation, and distribution are all automatic, saving time and effort. Usually, companies run into trouble to manage such copies of the old revisions. The distribution of new revisions has also become time-consuming, requiring control and follow-ups. Using electronic system brings the ability to control your document copies and tracking of will solve great problem controlling your documents. The integration of document control with your learning management system ensures that training tasks related to document changes will not fall through the cracks.

Stage 3: Review/Reject and Change Control

 

Problem #5: Neglecting review during document cycling.

As a Document Controller, you need to follow the document review procedure which is used to review and ensure that a document’s content is applicable and accurate based on current project objectives. In many cases, processes evolve without the documentation being updated, so changes done in the document are not fully reflected. ORCANOS e-DMS system is helping to implement the standard operating procedure and ensure that the actual process and documentation process are in sync.

Problem #6: Who needs to review what and when, is a big challenge. Image result for Review Reject document

Each document requires a different set of people to review it. Ensuring that each change is well documented and executed correctly, requires that the right people are involved in the change control process. Having too many people involved does slow down the process and reduce efficiency. At the same time, overlooking an individual or group during a change can result in issues down the line. So if for example, we perform engineering changes by the R&D group, it may be acceptable to the regulatory and quality team, but not passed by the manufacturing team, who may need to adjust their tools/jig to adopt the changes.

Problem #7: Product iteration information is largely based on “tribal knowledge.”

Knowledge preservation or knowledge transfer is always a risk. The complexity of some of the products as well the regulated path it needs to go through may take several years. So it is reasonable to think that at some point in time some of the people in the original design team might have been assigned to other business units or have left the company. In a manual process, you will need to collect paper documentation from remote resources. Some of them may be on someone’s  local PC or spread over email inboxes, so product history becomes not handy and overburden understanding the product evolution.

Our Suggestion for Mitigation:

Any developing industry using ALM tools will utilize iterations. Most commonly used methodologies such as Agile Scrum, DevOps or even traditional Waterfall are based on release and lifecycle of development reflected by their versioning number. Such iterations are used both before and after the product is released to the market, which makes change management crucial. Since requirements, test and all other types of changes are described by documents, we need to control every change. With an electronic system, you can control singular changes in the level of requirements, and route it based on relevancy to different groups of people. This will cause the change control process to be both efficient and thorough. Additionally, having a centralized repository for all product documents provides the ability to create traceability between documents, so when one is changed you can easily discover the impacts on others. Cloud-based systems also allow easy reference to the relevant documentation even long after a product has been launched. Having an electronic system also gives the organization the advantage of performing basic tasks such as e-signatures which comply with CFR 21 Part 11, Implementation of ISO 13485 Sec. 4.2 completely, timing and scheduling reviews, dynamically collect the relevant people for review and automating the distribution of approved documents.

Stage 4: Retrieval

 

Problem #8: Searching  a document

The need to reference a document arises in several cases such as daily use, internal audit, external auditor during any quality event. The ability to retrieve such documents efficiently is part of what today’s organizations are measuring up to. A common challenge among organizations is the investing of significant effort finding documents when they are needed. Using traditional paper documents in filing cabinets or electronic versions on file shares increases the risk of not being able to do intelligent searches. You want users to be able to search for documents and find them quickly.

Our Suggestion for Mitigation:

Many people are accustomed to searching for information by simply typing in the terms they are searching for, getting the desired results. In some cases, it is more efficient for users to find the documents they are looking for by browsing an organized hierarchical structure. It is important to support both search and browse approaches to finding records. In either case, associating the proper metadata to the document, as well as supporting full-text searching are critical. The system should enable your organization to find the needle in the haystack quickly.

Stage 5: Obsolescence

 

Problem #9: Misuse of documents that are obsolete.

Part of a regulated company’s day to day task is to maintain document archives, stored for historical purposes, as well as to avoid misuse. It is important to keep documents for as long as they are effective. The effective date of some documents may expire, and you need to renew them. It is not enough to only control the approval process, but the lifespan of a document must be determined. The document shall not be deleted by the concept but being blocked from mistaken use. Over time, the collection of documents can be overwhelming and clutter your quality systems, making searching more difficult.

Problem #10: ECO release of documents timing cause great effort.

Part of the change control procedure is the ECO release. The ECO form may include a set of documents to be released, and also reflects the changes in the revision of each document showing the newly approved version, as well the obsolete document. Using traditional methods requires close observation and control of each document through the logging of changes. Human errors and fault are common in such heavy ECO releases and can cause misleading distributed documents.

Our Suggestion for Mitigation:

Companies standard practice is to archived documents up to 15 years. There may be issues with keeping records longer than that period. Regulatory requirements usually dictate a company’s retention time frames. The time frame a document remains available becomes a RISK to meet the minimum regulatory requirements. An electronic system is ensuring that the access to approved documents or obsolete is well controlled. Storage today has become a neglected issue by most IT department.

So what do you need to do, to avoid the problems above?

If you are using paper-based or hybrid processes, making a move to a fully automated system will improve your quality management significantly. If management of your documents is your most pressing problem, it is time for you to find an out-of-the-box tool that fits your needs.  The available features as well as the complexity, and the amount of effort required to set up a system must all be taken into consideration when deciding on an electronic system.

Document Management Software Tool Selection

As you consider which document management software to select, or QMS, ensure the DMS covers other areas of your product lifecycle for example ALM (Design Control). The ALM part covers the R&D phase and the traceability to the design and validation documents, as well as to the traceability between different requirements in the V&V paradigm. ORCANOS | Medical solution is a one of a kind product that enables you to manage both R&D and Quality Management in one place, such as  RISK management (ISO 14971) and Complaint Management (ISO 13485 Sec. 4.2) which are an integral part of any Quality Management System.

ORCANOS Platform contains all core applications,  allowing access to an integrated quality management suite with the unlimited ability to create new modules and tools (BOM, ECO, CAPA, Training, Printing Labeling, Manufacturing with e-DHR and more) that you can use as needed. ORCANOS e-DMS systems can be used as a starting point solution, but also as the foundation of a quality management system. It is scalable, configurable, and there is room for adding more solutions and addressing future quality needs. ORCANOS is a leading vendor and pioneer introducing such integrated platform.

Conclusion

In regulated environments, document control is the sound basis of quality. It is not a stand-alone system; it has branches and links to other procedures and processes that directly/indirectly affect product quality and safety. The control of all relevant documents (and the process for changing those documents) is a   highly complex management task. Automating your manual or hybrid processes will significantly increase your organization’s efficiency, accelerate time to market, help maintain compliance, and reduce your overall compliance costs.

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.

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