Posts in Requirements Management Tool

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.

 

Orcanos e-QMS 4.0 – The new MRB process, getting it all in one place, how it works!?

November 10th, 2018 Posted by Requirements Management Tool 0 thoughts on “Orcanos e-QMS 4.0 – The new MRB process, getting it all in one place, how it works!?”

The Orcanos e-QMS Material Review Board (MRB) software module within the Orcanos e-QMS and manufacturing software enables you to electronically document, manage and track discrepancies with materials, whether it is raw materials, work in process or finished goods. MRB (plural MRBs) (manufacturing) Initialism of Material Review Board, a system of recorded investigative checks done on failed components or processes to improve quality.

Together with the MRB, there is another process that needs to be discussed which is the RMA. RMA is Return Material Authorization; it means you are being authorized to return the material back to the supplier. The reason you need an RMA is when it reaches the receiving department of the supplier then they don’t know what to do with it. This gives you the paper trail you need to be able to do the credits. Orcanos e-QMS system allows you to define the RMA and to give you an electronic form to manage the process, at any point of time you can export this RMA form to other format and to send it out to your supplier together with Orcanos e-Signature system according to the CFR 21 Part 11 regulation requirements. While the MRB could be something which you get from your supplier which you think is of suspect quality. Isolate it so that you can review it, look at it and figure out what to do with that.

Here is an example that will illustrate the flow between processes and documentation. Customer reports a problem into Orcanos Service Call center and issues a complaint form (according to the ISO 13485 Sec. 8.2). The analysis of the complaint results in two decisions, one that there is a RISK (according to the ISO 14971) to be handled and second that there is a need for a CAPA. The RISK assessment that will result in additional actions that all are addressed by Orcnoas RISK management (RMF) system the other activity around the CAPA will result in 3 types of actions. The corrective action (CA) which may direct to some immediate action items such as training, supply chain etc. The preventive action (PA) may result in an MRB process which will create additional action all documented electronically inside Orcanos e-QMS system. The 3rd type of action shall be the effective action which will measure the effectiveness of the PA/CA actions on the forecast of such event to occur again.

Here is one   example how the MRB get into action:

MRB

Orcanos e-QMS, MRB example:

MRB Form

The new Orcanos e-QMS edition 4.0 now includes the MRB as part of the system templates and allows you to start working with it immediately.

Try Now for Free

How to Evaluate Requirement Management Tool

October 17th, 2018 Posted by Requirements Management Tool 0 thoughts on “How to Evaluate Requirement Management Tool”

Author: Rami Azulay

Purpose

The purpose of this article is to prepare the focus group doing evaluation for solution of Requirement Management System (RMS) and to provide the organization with the necessary information to effectively compare Requirements Management Systems solution among vendors to select the best RMS for their individual needs and cost parameters. Requirement management in software engineering is integral part of the daily work and needs to meet very specific needs by the stakeholders using it. We in Orcanos are proud to present the world our years of experience in RMS POCs and to share this with any prospect who seek to find the best solution for them. We believe in fair competition and not afraid to hear No Thank You from our prospects. There is no perfect solution but there is one that is perfect for you.

Confidentiality

All information presented in this RFS, including any information that is subsequently disclosed by the Orcanos during the evaluation process, should be considered public and can be used by the public domain.

Background

Orcanos (https://www.orcanos.com) is a software vendor since 2005, We hold blue chip customers as well small/medium companies which use our software for both ALM or/and QMS process.

Orcanos solution cover in a complete manner the requirements from RMS system and due to our presence in the regulatory industry our RMS system include some unique capabilities to address such special needs. Orcanos system is 21 CFR Part 11 compliance system and for that it can turn any organization to a paperless organization which can completely archive its data electronically. Some of the main important RMS capabilities may include Generation of document from the electronic system, prioritization of requirements, the replacement of Word and Excel documents or other systems. The objective of such SAAS system is to be able to bring all stakeholders into the same system, requirements are not easily analysed or traced from customer need through to technical specification and test plan. Changes to requirements are not well controlled or communicated. As the organization’s projects continue to grow with more complexity, the requirements documents grow correspondingly to larger scale, the number of project participants and stakeholders grows, and the need for rigorous handling of the development and maintenance of requirements becomes more critical.

Most organizations use a Stage-Gate project management process and makes use of techniques such as Quality Function Deployment (QFD), Failure Modes & Effects Analysis (FMEA), Design for Manufacture and Assembly (DFMA) and Design Validation Planning & Reporting (DVP&R) in its product development procedure. Orcanos RMS system is capable to capture all that in one single repository and by that create a transparent flow of information between R&D, Quality and Manufacturing. Other uses of legacy system such Microsoft Office Project Server for Project Portfolio Management (PPM), Atlassian JIRA for bug tracking and Agile development, and Applications for Enterprise Resource Planning (ERP) or any thing else, for that Orcanos system is using the Zapier 1000+ apps integration tool which give the freedom to collect information from satellite systems and bring them all back into the same repository.

Criteria

1. Core Functionality

Rating:  

Critical

High

Medium

Low

Requirement Rating
1.1 The RMS represents Requirements as first-class entities in the system, each with a free-form text description.
1.2 The RMS allows Requirements to be grouped into Products and Projects.
1.3 The RMS maintains a unique identifier for each Requirement.
1.4 The RMS can represent Requirements of different types, e.g. Customer Requirements, Business/Legal Requirements, Design Requirements, Validation Requirements, Production Process/Test Requirements, Project Requirements.
1.5 The RMS captures derivation relationships between Requirements, e.g. Design Requirements are derived from Customer Requirements and Business Requirements, similarly Validation Requirements and Production Test Requirements are derived from Design Requirements.
1.6 The RMS stores priority or ranking metadata for each Requirement.
1.7 The RMS can manage Requirements for multiple Products with closely related or overlapping Requirements, e.g. product variants with different performance ratings or feature combinations.
1.8 The RMS can store validation criteria or performance targets for each Requirement where relevant.
1.9 The RMS supports iterative product development, where the Requirements for a Project to develop iteration N+1 of a Product are based on the Requirements from iteration N, with additions, modifications, and deletions.
1.10 The RMS allows Requirements to be transferred between different iterations of a Project.
1.11 The RMS stores a short name or title and a detailed description for each Requirement.
1.12 The RMS supports free-form text and other content (not part of a specific Requirement) associated with a Product or Project, e.g. for frontmatter, high-level description, explanatory text, etc.
1.13 The RMS supports figures (diagrams/images) in Requirements and other content.
1.14 The RMS supports tables in Requirements and other content.
1.15 The RMS provides comment or discussion features linked to each Requirement.
1.16 The RMS supports management of standardised sets of Requirements that are reused across Products and Projects, e.g. for a product type, target country of sale, or production facility or process.
1.17 The RMS supports incorporation of sets of Requirements by reference, e.g. sub-components, or interface and protocol specifications.
1.18 The RMS supports rich text formatting (e.g. bulleted/numbered lists, bold/italics, special characters) in Requirements and other content.
1.19 The RMS can store files as attachments to Requirements.
1.20 The RMS can represent Requirements in a hierarchical structure, e.g. for sub-components of a Product.
1.21 The RMS can manage Requirements for non-NPD projects, e.g. business improvement projects.
1.22 The RMS can capture use cases for a Product alongside the Customer Requirements.
1.23 The RMS can distinguish categories of Requirement e.g. Electrical/Mechanical/Firmware, Functional/Non-Functional, etc.
1.24 The RMS supports rendering mathematical formulas (e.g. LaTeX) in Requirements and other content.
1.25 The RMS supports rendering vector drawings (e.g. block diagrams, flow charts, UML) in Requirements and other content.
1.26 The RMS can capture design concepts for a Product alongside the Design Requirements.
1.27 The RMS can capture metadata about the source of a Requirement, e.g. customer, legislative, internal standards.
1.28 The RMS can be customised to add new metadata fields to Requirements for specific needs.
1.29 The RMS can capture product design documentation e.g. design decisions or component choices, and their relationships to the Requirements.

 

  1. Process Control

Requirement Rating
2.1 The RMS captures the history of all changes to individual Requirements, including before/after, timestamp, and the responsible person.
2.2 The RMS captures the history of a Project, including a snapshot of all Requirements at a point in time, either continuously or at designated project milestones.
2.3 The RMS flags Requirements changes (either in content or being added to/removed from a Project) for review of impact to downstream Requirements.
2.4 The RMS captures timestamp, responsible person and a justification when adding/removing Requirements from a Project.
2.5 The RMS implements a Change Request process, where a change to the Requirements can be proposed and reviewed before being officially accepted into the project.
2.6 The RMS implements a digital sign-off process for approving Requirements at Project gates (milestones).
2.7 The RMS implements an acceptance process for Requirements that are not ultimately satisfied by the Project, allowing an unmet Requirement to be waived or deferred to a later Project.
2.8 The RMS digital sign-off process (2.6) supports requiring multiple approvers to sign off.
2.9 The RMS supports the QFD process for deriving Design Requirements from Customer and Business Requirements.
2.10 The RMS supports the (D/P)FMEA process for deriving Validation and Production Test Requirements from Design Requirements.
2.11 The RMS can track the implementation status of a Requirement, e.g. to show progress during a Project, or to show which Requirements are already satisfied by a previous Project.
2.12 The RMS supports management of the Validation process by capturing test outcomes and evidence associated with a Validation Requirement.
  1. Analysis

Requirement Rating
3.1 The RMS supports Traceability Analysis of a Project to assess the coverage (necessity and sufficiency) of the Design Requirements against the Customer and Business Requirements, similarly the Validation and Production Test Requirements against the Design Requirements.
3.2 The RMS supports storing or linking to an analysis of each Requirement, e.g. cost/benefit, technical risk, competitor analysis, conflicts with other Requirements.
3.3 The RMS supports storing or linking to an analysis of each Project, e.g. market trends, competitor offerings, project justification and ROI.

 

  1. Roadmapping

Requirement Rating
4.1 The RMS supports Roadmaps of future Products and Projects.
4.2 The RMS captures future Product requirements for consideration in the current Project, e.g. for provisional hardware or architectural decisions to allow for anticipated future development.
4.3 The RMS supports Roadmaps of technology and research required to deliver future product requirements.
4.4 The RMS can capture ideas and feedback for future projects, e.g. from Lessons Learned, warranty and manufacturability data, direct customer feedback, or usage data from connected products.
4.5 The RMS can track whether a given idea has received a formal response and if it was ultimately incorporated into a Roadmap or Project.
4.6 The RMS supports Roadmaps of external influences e.g. market trends, external technology development, or legislative changes.
4.7 The RMS implements graphical presentation of Roadmaps in a time-based format, e.g. Gantt charts.
  1. Integration

Requirement Rating
5.1 The RMS exports data to well-formatted PDF or Microsoft Word documents.
5.2 The RMS exports data to Microsoft Excel or CSV.
5.3 The RMS PDF or Word export function can be customised for content, reading order, and style.
5.4 The RMS PDF or Word export function can be filtered, e.g. by Requirement type, category, or other metadata.
5.5 The RMS exports data to Atlassian JIRA.
5.6 The RMS exports data to ReqIF format.
5.7 The RMS imports data from Microsoft Excel or CSV.
5.8 The RMS has an external API e.g. REST or SOAP.
5.9 If web-based, the RMS uses consistent, human-readable URLs for a given Requirement, Product and Project.
5.10 The RMS imports data from Atlassian JIRA.
5.11 The RMS imports/exports data to/from Microsoft Office Project Server.
5.12 The RMS has an Extension or Plugin API.
5.13 The RMS has a marketplace or ecosystem of third-party plugins.
5.14 The RMS exports data to IFS Engineering for product documentation.
5.15 The RMS imports data from IFS CRM for customer feedback.
  1. User Interface

Requirement Rating
6.1 The RMS supports multiple simultaneous users.
6.2 The RMS is designed with usability as a primary focus, e.g. it is easy for new users to learn and navigate, tolerant of user errors, and efficient (in time and the number of clicks/page views) to perform common operations.
6.3 The RMS supports a customisable framework (templates, checklists, or examples) for guiding users in authoring complete and correct specifications.
6.4 The RMS provides assistance (e.g. wizards, online help) for users on how to use the software effectively.
6.5 The RMS supports multiple users working on the same Project simultaneously.
6.6 The RMS supports sending email notifications for significant events, e.g. changes to Requirements that may impact a given user, Projects awaiting a user’s review or sign-off, etc.
6.7 The RMS supports mind mapping for Requirements and Roadmaps.

 

  1. Security

Requirement Rating
7.1 The RMS stores all Organization data within Australian legal jurisdiction.
7.2 The RMS supports backup and rollback of Organization data with at least daily granularity.
7.3 The RMS has the option to store all Organization data on Organization owned IT infrastructure (on-premise).
7.4 The RMS can use Microsoft Active Directory / LDAP for user authentication.
7.5 The RMS supports role-based access control to individual Products and Projects.
7.6 The RMS provides a complete security audit history for access to and modification of Organization data.
7.7 The RMS supports download/export of all Organization data into a non-proprietary format.
7.8 The RMS supports access via an SSL or VPN connection over the public Internet.
7.9 The RMS supports low-cost or free/unlicensed access to authenticated users for read-only usage.

Costs

Submissions should include information about the typical implementation and recurring fees, IT infrastructure requirements, and system administration overhead of the solution for a company size.

Evaluation

Submissions should be evaluated by the organization based on his review of the submission, response to follow-up questions, publicly available information about the solution, and customer references. This is to feel the organization ability to address future issues and to understand its level of professional team. Orcanos comes with 13 years hands on practice and has many success projects and lessons learns, we are here not only to do what you ask but also to tell what you should not do.

Contact

Please address all correspondence regarding such RFS to:

Rami Azulay

VP Marketing and Sales

Rami.azulay@orcanos.com

10 Reasons Why To Use Electronic Quality Management System

June 2nd, 2018 Posted by Requirements Management Tool 0 thoughts on “10 Reasons Why To Use Electronic Quality Management System”

Medical Device Solutions

Ensuring Compliance, Improving Efficiency,
and Accelerating Time to Market

 

DOCUMENT CONTROL

FDA

 Document Management
 ISO

ISO

AUDIT MANAGEMENT

 Audit Management

Medical Device Solutions

Looking to Ensure Compliance, Improve Efficiency, and Accelerate Time to Market? The road from designing a new medical device to its actual delivery to recipients is long, bumpy, and expensive. Medical device manufacturers can lose millions of dollars in revenue for each day a new medical device is delayed from being delivered to market. If a new product is approved, the company manufacturing the device enters the next expensive phase: mass-production. To stay on top of this intense business and regulatory demands, medical device companies of all sizes throughout the world are turning to Orcanos to automate and streamline processes and enhance product development lifecycles, from concept to commercialization.

Solutions Specifically Designed for Medical Device Companies

Medical device companies have unique needs when trying to get their products to market faster while reducing overall costs and increasing internal efficiency. Orcanos produces software solutions that meet these needs by enabling medical device manufacturers around the world to enhance efficiency and implement effective processes. Our Solutions include:

Document Management

Thousands of documents generated throughout a company’s product lifecycle—such as those in the design history file (DHF) and device master record (DMR)—require a formal document management process to facilitate cross-functional collaboration and to ensure that documents are easy to track, retrieve, revise, approve, and share departmentally. Without an efficient system for managing documents, thousands of man-hours will be spent on even the simplest tasks. Orcanos’s document management solution provides a secure, web-based system for centralizing document collaboration and document control that improves efficiency, accelerates time to market, and ensures compliance.

Supplier Management

The complex process of accurately tracking suppliers on a company’s approved vendor list (AVL) requires continual management and monitoring. Such processes become exponentially more difficult as product designs and manufacturing processes change over time. Further complexities arise as increasing numbers of suppliers interface with different departments and divisions across the company. Orcanos offers companies the capability to efficiently manage and approve vendor lists and effectively track supplier quality and supplier status. Orcanos also automatically contains all supplier status and quality information (such as non-conforming material, COC, QC reports) in a single, easy to access location.

Risk Management

A consistent approach to assessing and managing risk is crucial to the successful quality and compliance management and precludes reputation damage from recalls or regulatory action. Orcanos integrates risk management throughout the organization to help unify all documentation and risk-related activities in a single centralized repository while providing a complete and accurate picture of the risk landscape across product lines and business processes.

Training Management

Tracking and documenting employee training is a regulatory requirement for the purpose of ensuring product quality. Orcanos automates the routing, tracking, documentation, training, and retraining of training tasks to help medical device companies meet rigorous regulatory requirements. Whenever there is a change in a Standard Operating Procedure (SOP) or other document linked to a course, all affected employees automatically receive new training tasks and notification via e-mail. Configurable training reports show pending, past due, and completed training, plus other critical information.

Quality Management

Quality event management is critical to success and profitability. By automating and effectively managing CAPA processes and integrating them with other quality endeavors, such as audits, nonconformances, customer complaints, and change control, Orcanos provides a foundation of excellence in controls, processes, and competency to guarantee that the solution implemented will provide the compliance results the organization demands and the methods and skills necessary for success.

Audit Management

Connecting audit processes with the entire quality system provide a holistic approach to quality management. Orcanos unifies and automates the scheduling of all audit-related activities to ensure that no vital processes are overlooked. With Orcanos, quality systems are consistently ready for inspections and audits.

Ten Reasons Why You Should Be Using Orcanos

  1. A fully integrated solution that connects all departments throughout the organization
  2. Reliable, consistent, and easy to use
  3. Orcanos’s unique transfer operational qualification (TOQ) provides completed validation and support documentation of IQ/OQ tests performed onsite at Orcanos, providing documented evidence that the applications perform correctly against their specifications
  4. Using an electronic, web-based system instead of paper-based systems saves time, resources, and money
  5. Flexible system – new modules, add-ons, and connectors can be added as needed
  6. Unparalleled expert technical support and customer service – support requests can be logged 24 hours a day
  7. Intensive training is available
  8. Compatible with most major integrators (i.e., Microsoft Office, Zapier, TFS, JIRA, GitHub etc.)
  9. Used by more than by giant and smb customers, including hundreds of medical device manufacturers throughout the world.
  10. Multiple languages and enterprise system architecture are designed specifically for multi-site, global deployments

Compliance Accelerated

Medical device manufacturers use Orcanos to meet key regulatory requirements while also increasing efficiency and keeping compliance costs down. Companies can enforce compliance
throughout every department and connect employees with relevant data and processes. The resulting environment enhances collaboration and allows managers to view all processes as a unified system. Call or visit www.orcanos.com to learn how hundreds of medical device companies are ensuring compliance and accelerating time to market.

 

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

 

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!

QPack ALM Requirements Management And Doors Integration

November 16th, 2012 Posted by Requirements Management Tool 0 thoughts on “QPack ALM Requirements Management And Doors Integration”
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