אורקנוס קפה 30.5.2019 – כנס איכות למצויינות

April 1st, 2019 Posted by Requirements Management Tool 0 thoughts on “אורקנוס קפה 30.5.2019 – כנס איכות למצויינות”
להרשמה לחץ כאן

מובילים את האיכות למצויינות דרך אנשים, כלים ומתדולוגיות

רח תוצרת הארץ 8, תל אביב. קומה 11 (בניין  Toha)

אורקנוס קפה חוזרת!

מפגש נוסף של מיטב אנשי האיכות בתחום של פיתוח ציוד רפואי, המאפשר דיון בסוגיות החדשות בתחום האיכות. במפגש נדון באתגרים של שנת 2019 ו 2020 וינתנו טיפים לעמידה בהתאמות החדשות לתקינה של 13485:2016 ISO במעבר מ- MDD ל- MDR

להוספה ליומן גוגל

הכנס הינו ללא עלות, אך דרוש רישום מוקדם

Links to presentations:

תוכנית הכנס

  • 18:00 – 18:30 – התכנסות וכיבוד קל
  • 18:30 – 19:15 – הרצאה בנושא העדכונים והיישומים של השינויים ב ISO 13485:2016 וה MDR מול MDSAP (אירית באומן, מנהלת אבטחת איכות באי.בי דנטל ישראל) – The Best Tips for the QA – RA 2019-2020
  • 19:30 – 20:15 – הרצאה בנושא ניהול קבלני משנה ואישור ספקים ומפיצים לפי דרישות ה- MDR החדשות (קרן צבר, יועצת איכות וולידאציה בלודן) – Purchasing Controls- ORCANOS Cafe 30.05.2019
  • 20:15 – 20:30 – דברי סיכום – The War On Paper – A Plan for going paperless

להרשמה לחץ כאן

Audit Preparation and Participation as Part of the eGMP

March 30th, 2019 Posted by e-GMP, regulation compliance 0 thoughts on “Audit Preparation and Participation as Part of the eGMP”

In this post, we will discuss how to maintain a constant state of audit Readiness for unexpected audits, as well as what you can do to prepare before the audit commences.

Gathering commonly requested items ahead of time we will also take an in-depth look at the role of the audit coordinator and provided detailed recommendations for the audit Operation Center.

Next, we’ll talk about how to handle the audit itself including the opening meeting gathering documents for the auditor answering the auditor’s questions laboratory facility tour and the exit meeting.

Maintaining Audit Readiness

As some audits can be performed without notice or it’s very short notice the laboratory should operate under a state of audit readiness at all times if you do receive a notice of the audit there are a number of things that can be done before the audit commences.

  • Review your Laboratories SOPs on receiving inspectors and handling inspections.
  • Review past inspection reports, and attempt to identify items that may be a particular interest or concern to the inspectors.
  • Try to determine the identity of the auditors and their area of expertise.
  • Assign each inspector a host.
  • Determine, as far as possible, the scope and methods of the audit, this will often be discussed during the initial meeting.
  • Book rooms for the auditors and a room to act as the operation center.
  • Identify subject matter experts for each area together with substitutes.
  • It is not unknown for auditors to request to observe a demonstration of a particular method. This may, in particular, happen during a client audit when the client wishes to assess the competency of the laboratory to perform a particular test.  It would be good practice to identify someone with significant experience to perform any demonstrations before the audit commences.
  • Establish as much as possible a tour route.
  • Walk through the tour route and check all of the following:
    • Instrument log books instrument status and calibration status.
    • The expiry date of chemicals, reagent, mobile phases and solvents – remove or revise all out-of-date reagents.
    • For laboratory glassware, in particular, confirm the calibration markings on volumetric glassware are clearly visible.  Also, confirm that the correct grade of glassware is being used and be able to confirm this with the documentary evidence.

Review testing schedules, it is best to concentrate on routine work during an audit, especially a regulatory audit, and avoid working on more challenging activities such as investigations.

Using Orcanos eQMS system allows you to control electronically the audit readiness and allow you to stay focus on the daily tasks. Orcanos provides a set of reports you can have free access to such as:

  1. Audit Readiness – SOP Annual Review (Effective Date > 300 days)
  2. Audit Readiness – Previous Process Checks with Low Grade (1 – 3)
  3. Audit Readiness – Deviation Summary Reports
  4. Audit Readiness – Complaint Investigation Report
  5. Audit Templates
  6. Many more…

It is a good practice to have such documentation readily available on site. If necessary Orcanos eQMS system will allow recalling all such documentation electronically with no need to go onto the remote site. Orcanos system will preserve your data for at least 15 years and more so no need to archiving.

 

 

NOTE: These recommendations are also applicable for Good Laboratory Practice (GLP) required by the ISO 13485:2016 and now by the new MDR and MDSAP.

Orcanos Innovation Platforms to Meet Automotive Compliance Standards

March 14th, 2019 Posted by Requirements Management Tool 0 thoughts on “Orcanos Innovation Platforms to Meet Automotive Compliance Standards”

System Engineering Process Group (SYS)

 

Compliance standard in the automotive industry: Vehicle manufacturers understand the importance attached to comply with standards in the automotive industry. Having to comply takes into account, the safety of such a vehicle. As a result, compliance agencies have come up with several compliance codes that decide the level of compliance of the automotive in terms of safety. Some of them include the following:

  1. IEC 61508 (Functional Safety of Electronic/Electrical/Programmable Electronic Safety-related Systems).
  2. ISO 26262 (Road vehicles – functional safety)
  3. Automotive SPICE (Software Process Improvement and Capability Determination). Also referred to as ISO/IEC 15504
  4. Capability Maturity Model Integration (CMMI)

For this writeup, our focus is on 2 and three, i.e. ISO 26262 and Automotive SPICE.

The ISO 26262 is an improvement on the IEC 61508. Its goal is to determine the level of safety/risks in the functional use of an automotive. By doing this, it accesses the electronic functionality of the vehicle from conceptualization, design, creation, and production. Its goal is to ensure that vehicle safety is paramount especially for its habitats. Since the 2009 publication of the (DIS) of ISO 26262, this ISO has gained traction. With legal practitioners using it as a standard in defending cases. It uses a set of guides that help to determine the compliance level of a system: either software or hardware. It provides the safety lifecycle, the risk classes; it gives the safety requirements through the AILs for minimizing residual risk to an acceptable minimum and provides a validation method for ensuring that vehicle manufacturers meet a safety standard.

Automotive SPICE is also known as ASPICE. It is a set of really technical documents that assist in the creation and adherence to electronic software safety and functionality. ASPICE provides the working standard that is needed for manufacturers to achieve regulatory fixed standards of electronic software for their vehicles. Automotive SPICE is a document duly owned by the VDA (Verband Der Automobile industry e.V. ASPICE has a Process Reference Model document that’s crafted for this particular industry.

The PRM consists of the PRM consists of the Primary Life Cycle, Organization Lifecycle, and Support Lifecycle. The Primary Lifecycle then consists of the Acquisition, Supply, System Engineering and Software Engineering Process Groups. The Acquisition group, also termed the customer acts ACQ. And it includes the following: Agreement, monitoring, technical demands, Process, and Legal requirements. The supply group consists of the process release and supply tender. The system group includes specification, design, integration and qualification test. The Software engineering group provides analysis, design, construction and verification, integration and communication.

The ASPICE document module is a set of technical documentation that is needed for the implementation of a full standard electronic software for an automobile. The ISO 26262 on the other hand, is a document that consists of technical implementation standards that are needed for the standardization of the functional safety of the vehicle.

OPORTUNIDADES EN LA NUBE PARA EL SECTOR AUTOMOTRIZ

March 14th, 2019 Posted by ASPICE, Automotive 0 thoughts on “OPORTUNIDADES EN LA NUBE PARA EL SECTOR AUTOMOTRIZ”

Los servicios en la nube implican la traslación de datos o información al Internet utilizando servidores remotos. Esta práctica se trata del almacenamiento y la administración de datos utilizando Internet en lugar de las computadoras locales. La industria automotriz es un sector importante que puede beneficiarse de la migración a la nube. Esta industria es conocida por su enfoque en la tecnología y la innovación, lo que hace que el servicio en la nube sea una solución perfecta. El servicio en la nube puede ser utilizado para lograr lo siguiente en la industria automotriz:

 

  1. REDUCCIÓN DE COSTOS

La mayoría de las empresas automotrices gastan mucho dinero adquiriendo infraestructuras internas y hardware de TI para el almacenamiento de datos. Asimismo, gastan dinero en tener estas infraestructuras actualizadas y en mantenerlas. El servicio en la nube ha proporcionado una forma de erradicar esto.  Ahora, los datos se pueden cargar en un servidor remoto, y el proveedor de servicios será responsable de la gestión y reparación de los servidores, lo que ayuda a las empresas a reducir el costo inicial de la creación del departamento de TI con recursos humanos y equipos, así como el costo de mantenimiento de la gestión y reparación de los equipos.

  1. MEJORA EN LA SEGURIDAD DE LOS VEHÍCULOS

El servicio en la nube ha permitido que los vehículos inteligentes adviertan a los conductores de una inminente fatalidad o tomen las medidas necesarias para evitar tales situaciones. Por ejemplo, actualmente muchos autos alertan a los conductores de condiciones peligrosas en la carretera, algunos incluso van un paso más allá tomando medidas en favor del conductor, por ejemplo, un freno de auto se activa justo antes de que se produzca una colisión. Estas mejoras han ayudado a reducir el índice de accidentes en la carretera, ya que el conductor no es la única mente “inteligente” en el automóvil.

  1. SISTEMAS DE CABINA MEJORADOS

El acceso a la nube ha hecho que conducir un auto sea una actividad divertida. La mayoría cuenta con sistemas de GPS y también se conectan a Internet a través del teléfono del conductor. Ahora se pueden obtener actualizaciones de tráfico en lugar de tener que revisar los teléfonos continuamente mientras se conduce. Además, esto alivia los sistemas de “información y entretenimiento” de los fabricantes de automóviles al utilizar la nube para obtener información sobre el conductor y, por lo tanto, las actualizaciones se adaptan a las necesidades del mismo.

  1. REDUCCIÓN DEL RIESGO

Las instalaciones automotrices pueden aumentar su seguridad y minimizar sus riesgos de fallas haciendo algo tan simple como trasladarse a la nube. Los proveedores de servicios en la nube cuentan con personal experto dedicado que trabaja todas las horas del día gestionando y garantizando la seguridad en todo momento; estos expertos también llevan a cabo comprobaciones rutinarias para evitar tiempos de inactividad.  Además de esta protección las 24 horas del día, los entornos de la nube también crean copias de seguridad de datos e información, y la empresa automotriz no estará expuesta después de una pérdida accidental de datos. La tarea más importante que realizan los proveedores de servicios es proporcionar un control de seguridad potente (cifrado).

  1. MENOR COMPLEJIDAD

Cuando se trata de la industria automotriz, hay muchas piezas móviles, así como datos relacionados con la producción de un vehículo. La industria es compleja y maneja información relacionada con actividades tales como simulacros de ingeniería, procesos empresariales, demanda, análisis de clientes, logística y mucho más. La administración de dicha información puede ser muy tediosa y difícil de comprender. Sin embargo, con la introducción de los servicios en la nube en el sector, los fabricantes pueden aprovechar fácilmente la facilidad que ofrece el entorno de la nube para clasificar los datos de forma rápida y eficiente.

 

Sobre el autor, Rami Azulay

Rami tiene más de 24 años de experiencia en varios puestos de desarrollo de software y control de calidad. Utilizando su amplio conocimiento de las operaciones y la calidad, Rami fue uno de los principales arquitectos del software Orcanos en 2005 y más tarde se convirtió en el vicepresidente de ventas y marketing de Orcanos. Rami tiene una maestría en Ciencias de la Computación.

 

CLOUD OPPORTUNITIES FOR AUTOMOTIVES

March 10th, 2019 Posted by ASPICE, Automotive 0 thoughts on “CLOUD OPPORTUNITIES FOR AUTOMOTIVES”

Cloud computing involves the movement of data or information to the internet using remote servers. This practice means the storage and management of data using the internet instead of local computers. The automotive manufacturing industry is a significant sector that can benefit from migration to the cloud. This industry is known for its focus on technology and innovation, which makes cloud computing a perfect fit. Cloud computing can be used to achieve the following in automotive:

 

  1. COST REDUCTION

Most automotive companies spend lots of money buying in-house infrastructures and IT hardware for data storage. They also spend money keeping these infrastructures up-to-date and also maintaining it. Cloud computing has provided a way to eradicate this.  The data can now be uploaded to a remote server, and the service provider will be responsible for managing and repairing the servers, this helps companies push off the initial cost of a setting up the IT department with human resources and equipment and also the maintenance cost of managing and repairing the equipment.

  1. IMPROVEMENT IN VEHICLE SAFETY

Cloud computing has enabled smart or intelligent vehicles that warn drivers of impending doom or take necessary actions to avoid such situations. For example, many cars now alert drivers of dangerous road conditions, some even go a step further by taking action for the driver, e.g. a car brake going off just before a collision occurs. These improvements have helped to reduce the rate of accidents on the road as the driver is not the only “intelligent” mind in the car.

  1. IMPROVED CABIN SYSTEMS

Access to the cloud has made driving a car a fun activity. Most cars have GPS systems and also connect to the internet via the driver’s phone. One can now get traffic updates as opposed to checking their phones all the time while driving. Also, this relieves the automakers “infotainment” systems by using the cloud to get information about the driver and so updates to suit the driver’s needs.

  1. RISK REDUCTION

Automotive facilities can boost their security and minimize their risk of failures by doing something as simple as switching to the cloud. The cloud service providers have dedicated expert staffs that work all hours of every day managing and ensuring security at every point in time; these experts also carry out routine checks to avoid downtimes.  In addition to this round the clock protection, cloud environments also create data and information backups, and the automotive company won’t be in the rain after an accidental loss of data. The most important task done by the service providers is delivering powerful security control (encryption).

  1. REDUCED COMPLEXITY

When it comes to the automotive industry, there is a lot of moving parts as well as data involved with producing a vehicle. The industry is complex and handling information relating to activities such as engineering simulations, business processes, demand, customer analysis, logistics and many more. Managing such information could be very tedious and hard to comprehend. However, the introduction of Cloud Computing to the industry, manufacturers can easily leverage the ease that the cloud environment provides to sort through data quickly and efficiently.

The Opertunities Cloud Brings to the Automotive Industry

March 6th, 2019 Posted by ASPICE 0 thoughts on “The Opertunities Cloud Brings to the Automotive Industry”

If you are a new startup or matured supplier that address solution of OEM to the Automotive Industry you probably already know the requirements coming from the supply quality auditor of your prospect regarding the ASPICE. This is the time to think it over and look at what the cloud solution is offering today to vendors like you.

We gave in this slide deck a quick glance on how the cloud world can extend the possibilities for vendors that are outside of the traditional automaker community.

We have built state of the art system Orcanos that already serves many companies helping them daily to achieve their compliance goal, and more than that, to maintain the organizational culture needed to keep winning the trust of the market.

 

 

Orcanos Unveils New Corporate Headquarters

February 3rd, 2019 Posted by Requirements Management Tool 0 thoughts on “Orcanos Unveils New Corporate Headquarters”

New Facility Sets Stage for Software Solution Provider’s Future Growth

TEL AVIV CITY —Feb 3, 2019 — Orcanos, a global provider of enterprise software solutions for life science and other regulated companies, today announced it has moved into its new corporate headquarters. The completely renovated space at 24 floors designed by the distinguished architect Ron Arad who was granted the liberty to create an unblended building which is located in the central junction of the city of Tel Aviv, Israel.

Our employees will work in the new building, the new HQ was carefully chosen with longevity in mind. Orcanos foresees future growth that will expand its workforce in Tel Aviv and we selected a location that is accessible to all of Israel citizen with an easy trip by train.

“We are proud to be a Tel Aviv-based company for over 14 years, and when choosing a new office space to accommodate our growth, we wanted a location that offers the best of Tel Aviv, Israel” said Zohar Peretz, CEO of Orcanos. “The urban view from the building to all major sites and its premier location close to downtown Tel Aviv, as well as being just minutes away from some of the finest attractions and outdoor recreation activities in the nation, all to provide an environment that is conducive to innovation. It has nearby amenities to also enable a happy work-life balance, community interaction which is an important part of our company culture.”

In addition to choosing an ideal location for employees, the building features a high-tech modern design, with open floor plans for collaboration. Space features expansive breakrooms that are fully stocked with complimentary food and meeting rooms that are designed to encourage teamwork.

“We provide our employees with the best possible facility for the collaborative and innovative culture that has fueled Orcanos for the past 14 years,” said Rami Azulay Orcanos VP Marketing & Sales.

Media Contact:

Kfir Peretz

Internet Marketing

+972-3-537-2561

kfir.peretz@orcanos.com

Got Battery! – You Need a Battery Performance Alert (BPA) Test Protocol

January 24th, 2019 Posted by Recall, Risk Management 0 thoughts on “Got Battery! – You Need a Battery Performance Alert (BPA) Test Protocol”

Since the FDA issued an update a recall notice several times (St. Jude Medical, Philips,  ) with information about the Battery Performance Alert (BPA), a new battery performance test protocol tool is offered by Orcanos Medical new release.

Recent recall talk about poor battery performance that causes several injuries and potential for death that trigger us to write something out for you. A test protocol that Skelton the basic method to measure the performance of your battery and level of RISK you needs to address.

Orcanos monitor the recall market and perform engineering analysis on the events and try to come up with better ways to prevent such cases from happening again.

You can have access to this new Battery Performance Alert (BPA) Test Protocol (DOC-5009) directly by registering to our FREE application from our web site: www.orcanos.com.

 

 

Orcanos issues new risk system including risk made by medical devices in the field of Neurosurgery Software Recalled Due to Display Inaccuracies

January 9th, 2019 Posted by ISO 14971, Recall, RISK Assessment, Risk Management, Safety 0 thoughts on “Orcanos issues new risk system including risk made by medical devices in the field of Neurosurgery Software Recalled Due to Display Inaccuracies”

Orcanos issues new risk system including risk made by medical devices in the field of Neurosurgery Software Recalled Due to Display Inaccuracies. The software, when used with the medical device Navigation System, provides 3D images of a patient’s brain to help neurosurgeons navigate surgical tools and implants used during surgery.

The Software glitch may affect the intended use of the device. This new risk, the following does not include reported problems that included a patient death potentially linked to the case.

It was a Class 1 recall alert for MRI-guided surgery device. Class 1 recalls, the highest severity level, involve product problems that can cause death or serious injury.

Hazard: The software displays incorrect information during biopsy procedures that could result in serious or life-threatening patient harm. During the procedure, the software monitor may show that the tip of the surgical tool has not reached the target and could prevent the neurosurgeon from accurately seeing the location of the tools in the patient’s brain.

Failure Cause: The offset appears to have been caused by an interaction between the device probe and the MRI environment

Failure Effect/ Harm: The surgeon could potentially insert the tool too deeply, damaging the patient’s healthy tissue, brain or blood vessels.

Risk Control (RISK-5005):

 

Orcanos 4.0 new release now includes a complete training program plan to support the GMP process

January 8th, 2019 Posted by e-GMP, Requirements Management Tool 0 thoughts on “Orcanos 4.0 new release now includes a complete training program plan to support the GMP process”

Orcanos 4.0 new release now includes a complete training program plan to support the GMP process. The Orcanos new release involves a set of optional training tasks with a list of topics and agenda to be covered in order to be in compliance with the GMP. These training topics are covering Medical Device and Pharma producers including Cannabis growers who need to comply with the enforcement of the strict regulations by the legislation of the local government.

Orcanos as a world leader in the eGRC and eQMS and ALM market happy to get you the list of topics in a specific each subject area according to your professional demands, please simply click www.orcanos.com to get your FREE edition.

Some covered subjects below:

  1. Quality Assurance
  2. Microbiology
  3. GMP in Pharmaceutical Development
  4. GDP
  5. Computer Validation
  6. GMP for APIs and Excipients
  7. Medical Devices
  8. Packaging
  9. GMP in Biotechnology
  10. Regulatory Affairs
  11. Quality Control
  12. Sterile / Aseptic Manufacturing
  13. Technical Operations
  14. Validation
  15. GMP Basic Training Courses
  16. Data Integrity

Here are some of the benefits of using Orcanos  as the foundation of your e-GMP system:

  • Automation and Standardization: With Orcanos eGMP software, you can standardize all documents-based processes and automate distribution/routing, review, follow-up, escalation, and approval of documents. It makes search and retrieval of documents faster and easier.
  • Centralized Platform: Orcanos can serve as a centralized platform for all quality documents and records critical to eGMP compliance, making it essentially your eGMP system. Orcanos is web-based so authorized users have access to the system from virtually anywhere 24/7 not holding your production line and allow granting confirmation service without the local presence or human resources.
  • Connectivity: Orcanos is unlike other eGMP software solutions in the sense that it can connect all quality processes, including document control, training control, audit management, nonconformance management, CAPA, MRB, DHR and change control. This connectivity will help ensure that quality and other issues will not fall through the cracks.
  • Mobile Access: With Orcanos adoptive technology, users can access the system using a tablet or a smartphone. This capability is a distinct advantage of Orcanos over other eGMP software solutions and it can be very helpful for users out in the field or those constantly traveling. Those users will be able to participate in documents-based processes critical to eGMP compliance even when they are not in their local office.
  • Validated System – Orcanos is a validated system that no customization requires any effort invalidation. It is fully CFR 21 Part compliance system and already servers many customers around the world.

 

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