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cGMP – Design & Development Plan (DDP) – ISO 13485:2016(6) Clause 7

May 11th, 2019 Posted by Requirements Management Tool 0 thoughts on “cGMP – Design & Development Plan (DDP) – ISO 13485:2016(6) Clause 7”

Defining the stages of design and reviewing every stage of the design process is one of the requirements of ISO 13485 Section 7.3.5 for design and development. The task of identifying and reviewing designs at every stage is accomplished using the design control SOP. Once the User Requirement and Specification (URS) for a medical device is established, the next step in the planning stage is the Design and Development Plan (DDP).

Every product has its unique design and development plan, and they appear in the products documentation as either DDP or D&DP.  There are two main things to consider when creating a Design and Development Plan for a medical device.

  1.      Draft the plan and approve it using the design control system.
  2.      At crucial moments in the design stages, update and review the plan.

 

What is in the DDP

The Design and Development plan will differ with the complexity of each product as well as with the organization that produces them. For a simple product, the DDP can be in the form of a basic flow chart. However, with a more complex product, the design and Development plan will be in the form of a well-detailed Gantt chart.

 

The first thing that the DDP should cover is the objectives and goals for the product. This will help clarify the purpose of designing the product and its functions. Next, the DDP should note the various departments involved in the designing of the product and their roles. In addition to that, information on contractors or sub-contractors that will be contributing to the project. The assignment of responsibility as well as documenting them is vital to the success of the product design. Likewise, collaborations and shared responsibility should be elaborately defined to eliminate ambiguity or confusion. This is vital if the project involves multiple teams or departs.

The design and development plan should also have a breakdown of tasks alongside the people/team responsible for them. The task breakdown should include the following;

  • The time duration for the product design.
  • The resources that would make the project a success.
  • Individual responsibility for set tasks.
  • Allocation of resources.
  • Criteria for fulfilling each task
  • Collaboration points and the teams are collaborating on a specific task.

The task breakdown will help optimize the time it takes to complete the product and get it ready for the market. There should be a report documenting the target for each task, and it should have tests and studies that prove that the product is safe for use. Some of the tests and studies to consider are as follows;

  • Shipping studies
  • Biocompatibility testing
  • Validation of sterilization processes
  • Non-Clinical animal studies
  • Electromagnetic Field (EMF) Interference studies
  • Mean-time-to-failure-studies
  • Clinical evaluations

 

The tests and studies to be conducted will depend on the type of product design and the function of that product.

Another set of criteria that should be present in the design and development plan is what to expect from the activities of design transfer, and how to monitor what is being transferred. The expected result from the design process should also be weighed against the process input.

Problem with Design and Development plan

The biggest problem that comes with a DDP is the way the project manager tends to overestimate the product design timeline. Usually, such a problem arises with a lack of experience, lack of optimization and flexibility to the plan, and trying to work backward. It is important that tasks are completed on time, but there should be room for updates to account for unforeseen circumstances in the design process.

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cGMP – Customer Related Processes and Requirements – ISO 13485:2016(4) Clauses 7

May 4th, 2019 Posted by Requirements Management Tool 0 thoughts on “cGMP – Customer Related Processes and Requirements – ISO 13485:2016(4) Clauses 7”

 

The purpose of Customer Related processes as stipulated in the ISO 13485:2016, is to make sure that companies keep to a high standard when it comes to the products and services they offer to customers. In other words, it is a way of ensuring that the customer is the focus of the company and its product.

What the ISO 13485:2016 is hoping to achieve is a document that outlines an established User Requirement. The practice which started with the software industry helped to ensure that products meet the desired outcome of the end-users. Companies in today’s world, are concerned with how the user interacts and experiences the product, rather than what they need in their design process. Hence, abandoning the need for User Requirement for User Experience.

Apple products are an example of how design focuses on user experience instead of user requirement. Henry Ford, the famous founder of Ford Motors, made a quote that reveals a unique flaw with user requirement. He said that if he had been opportune to ask people what they required, they would have responded that they needed faster horses rather than cars.

While the software industry is embracing the concept of user experience, the medical device industry is still relying on user requirement. Although there is hope that the medical device sector will get there, we will be addressing User Requirement Specification (URS) as a part of the ISO 13485 clauses for customer-related processes and requirements.

Considerations Demands by ISO 13485 for Product Requirement

One of the most vital requirements for the product, as stipulated in the ISO 13485 clause, is the requirement for both delivery and post-delivery of products. There have been cases where companies failed to supply requirement for products as they relate to the installation, maintenance, training, packaging, calibration, and servicing. The ISO 13485 does mandate that these requirements be available and if they aren’t, they should be a justified reason for their absence.

Typically, not all products require all parts of the requirements. For example, the User Requirement Specification (URS) for a disposable device might only contain a section that justifies why there is no product requirement for calibration, servicing, maintenance and training. Additionally, another critical information stated in ISO 13485 is the fact that requirements not mentioned but needed for the product use will be identified. The stipulation helps to address the intent for consideration for product requirement during usage.

A disposable contact lens is an ideal example in clarifying implied consideration for the product requirement. Let’s say that the average shelf life for the contacts is 2 years as stipulated in the product requirement. However, the contact usage life cycle after the customer opens the seal is not accounted for in the requirement. Hence, should a customer use the lens for a week consistently before discarding it, while testing under such conditions has no to be done, implied product requirements means that the company has violated a requirement under the ISO 13485. Likewise, companies have to fulfill all applicable requirement such as the region and market for the product to best determine which product requirement to follow and note them in the product requirement document. In totality, even though the requirements may be specified or implied, they have to be met.

Product Requirement Review before commitment

This section of the ISO 13845 mandates the review of the product requirement long before the product gets to the customer. The review should cover the following;

  • The documentation and definition of product requirements.
  • The fulfillment of all applicable regulatory requirement.
  • Updates on contract requirements that exist in previous product requirements.
  • The capability of companies to satisfy the requirement.
  • Planning and execution of required training.

All the review requires are pretty standard and can be met easily. The design and development team is responsible for the generation, design, and review of a URS document. Similar to every other report, the User Require Specification document will be revised for the entire length of a product. It is crucial that recisions be tracked and noted and more critical, changing numbering each revision or updates should be avoided as references to previous updates is a possibility. Similarly, with each new update and stage in the development of a product, the URS should be revised and updated. The same principle applies to contract updates for customer-based products as changes that exist with previous requirements need to be addressed.

Communication

Communication is the last major part of customer related process under ISO13485 and must be appropriately managed. All forms of communications with customers to be the individual or commercial customer requires careful consideration. A requirement that covers all forms and ways in which communications with customers are performed must be made available. The requirement covers; inquiries about orders, contracts and their amendments, product information, advisory notes, and feedback processes including complaints.

Also, there needs to be a way to categories which customer related communication that should be submitted to regulatory organizations alongside a scheduled time and system for the process. The communication that organization submits will vary with where they market their product and the industry category of their product.

 

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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

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)
  • 19:30 – 20:15 – הרצאה בנושא ניהול קבלני משנה ואישור ספקים ומפיצים לפי דרישות ה- MDR החדשות (קרן צבר, יועצת איכות וולידאציה בלודן)
  • 20:15 – 20:30 – דברי סיכום

להרשמה לחץ כאן

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.

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

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 EQMS

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

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  

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Contact

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Tel Aviv, Israel
+972-3-5372561
info@orcanos.com

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