Posts in Company News

QPack 7.0 Announcement

October 3rd, 2013 Posted by Company News, Events 0 thoughts on “QPack 7.0 Announcement”

Orcanos is proud to announce that their software, QPack 7.0 for Medical Device Development, is planned to be released on 01.01.2014.

Document Control and Electronic Signature

QPack 7.0 Provides a document control with electronic signature, that automates ISO 13485 practice, thus providing small-medium medical device manufacturers an efficient and cost effective tool set that serves most of the medical device development aspects.

Forms Management

QPack will provide tools for building and managing all kinds of form, such as CAPA, ECO, which are generated using QPack Document Generator with dynamic information, ready for submission.

QPack Web

QPack Web will provide better web interface to QPack database, allows query information, add and edit information

QPack Mobile

QPack Mobile™ started with the desire to take years of experience working closely with our end users and put their wishes on a mobile solution. To make ALM user experience even simpler, more useful, and more enjoyable – but still feel familiar with Orcanos line of products. The design of QPack Mobile™ gives more control over your ALM and more productivity at work. The result was making your ALM work easier in achieving your daily goals, spend less time inside QPack ALM to free time for professional work

Customer Complaints

Complaints in medical device can be submitted from many different sources, such as sub-contractors, distributors, retailers, and even end users, such as doctors and patients. As complaints are not desired by any organization, medical device manufacturers are submitted to treat each complaint in a prompt and professional manner, submitted to regulations. This means the customer complaint management process must be handled properly following the acceptable process, starting from complaint receipt, and continues to assigning ownership, management, investigation and ultimately to resolution and closure.

Elcam Medical Mitigating The Approval Risk – By Placing their documents on Pre-Audit alert system that implemented the complete V&V Medical Device module

July 14th, 2013 Posted by 510(k), Company News, KPI, Software Lifecycle Management, Validation and Verification 0 thoughts on “Elcam Medical Mitigating The Approval Risk – By Placing their documents on Pre-Audit alert system that implemented the complete V&V Medical Device module”

Based 2,323 California biomedical companies research, here are the main 10 threats those companies has reported on

  • #1 – FDA regulatory / environment
  • #3 – R&D productivity
  • #7 – Intellectual property protections
  • #8 – Ability to demonstrate effectiveness
  • #9 – Product liability
  • #10 – Unprepared workforce

The unspoken rule is that at least 50% of the studies published even in top tier academic journals – Science, Nature, CellPNAS, etc… – can’t be repeated. More than that if there was a development behind those studies it was impossible to recreate the documentations requires utilizing their business potential.

According to the same research the following answers given to the question: Why did the company delay the research or development project? Were as follows:

  • 40.2% – Funding not available (Second Round)
  • 27.8% – Regulation (FDA, EPA, SEC)
  • 25.8% – Change in corporate priorities or strategy
  • 4.1% – layoffs
  • 7.2% – Other

Orcanos Implementing NPI (New Product Introduction) for one of the legacy Israeli Medical Device company Elcam Ltd. In this project the focus was on getting the project started on the correct regulatory path and have taken the initiative documents created by the R&D group into a preset system that control and governance the regulatory path selected by the organization. The overall idea was to define the development path in which the specific product shall be using and to match the perfect system that will control and governance each step in the development lifecycle. To achieve this goal we have selected QPack Medical™ system that accepted the validation documents and for each document the system created set of KPI (Key Performance Indicators) as well as KRI (Key Regulatory Indicators) that triggered QPack Medical alert system with Pre-Audit notifications.

 

Mitigating Audit-Submission Risks

 

 

For example:

The insertion of MRD documents during the Idea/Concept stage trggered the following alerts

KPI

  • Market Requirements missing coverage matrix
  • Market Requirements maturity based on functional test results
  • Market Requirements missing due date
  • Unapproved market requirements
  • Readiness for PDR review

 

KRI

  • Missing Market Requirement Document
  • Missing Market Requirement  Specifications
  • Market Requirements missing traceability to product requirements
  • Market Requirements missing validation procedures

 

 

 

 

 

Israeli software firm Orcanos eyes drug sector to boost growth

June 18th, 2013 Posted by Company News, Events 0 thoughts on “Israeli software firm Orcanos eyes drug sector to boost growth”

TEL AVIV, June 18 (Reuters) – Israel-based Orcanos, whose software aims to help companies develop and produce products more cost-effectively, predicts its sales will grow by 25 to 30 percent annually as it moves into new markets and regions.

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