Clik here to view.
Why the FDA Increase Software Classification from Moderate LOC to Major LOC?
From our advisory board member Mr. Mike Zeevi Dear all, These are very trying times and we are trying our best to keep it together. This year, as you can understand, has been quieter than previous...
View ArticleOrcanos Integration with Zapier
We’re really excited to announce our coming integration with Zapier, which brings the full power of Orcanos to more than 2000 applications. You will be able to easily link Orcanos work items such as...
View ArticleWhy Product Recalls Help Us To Expect The Unexpected
With a global pandemic still generating daily headlines, there is a defined need for quality management professionals to keep their eye on the ball, both in terms of the product lifecycle and the...
View ArticleWebinar | Build a Document Control System to ensure ISO and FDA compliance in...
Many companies implement an electronic document control system, for meeting the regulatory requirements given by the FDA, CE, and other bodies. In this session, you will see how easy it is to do the...
View ArticleOrcanos Integration with Zapier
We’re really excited to announce our coming integration with Zapier, which brings the full power of Orcanos to more than 2000 applications. You will be able to easily link Orcanos work items such as...
View ArticleClik here to view.
cGMP Data Integrity new Requirements adopted by the FDA and WHO
Data integrity reinforcements have become a highlighted topic. We want to switchgear in this post around data integrity around multiple organizations. If you wish to book a demo with us, please feel...
View ArticleClik here to view.
Software System Change Control and Validation – What you need to know
Anyone using a Computer Software system needs a reliable validation program (Computer Software Validation – CSV). We always need to know that the software is giving us the results we expect: It’s...
View ArticleTest
Test The post Test appeared first on ALM Software Tool – Orcanos Software – ALM And Quality Management.
View ArticleClik here to view.
Rami Azulay, Orcanos: “a collaborative working environment keeps the...
It is relatively easy to come up with an idea for a product compared to creating a team that would work on it or successfully launching it into the market. To achieve a consistent and flawless...
View ArticleClik here to view.
SERVICING ACTIVITIES vs. COMPLIANT (ISO 13485 Chapter 7)
Service activities are similar to Installation or Assembly services. However, some devices or equipment do not require servicing, they are often tagged as disposable devices. Nevertheless, should a...
View ArticleClik here to view.
ORCANOS In Medica During 14 – 17 November 2022 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,...
View ArticleClik here to view.
Orcanos Design Control Tag Compare Function
Revile The Document Compare Function Are you a manufacturing business owner of medical devices, pharma, automotive, or defense? looking for an efficient way to compare, update, and manage design...
View ArticleClik here to view.
What are the 5 frequent GMP Audit Findings, and How To Avoid Them using eQMS...
Modern technology has made GMP audits more efficient and reliable. With the advancement of software such as eQMS, companies are now able to systematically monitor and control their quality management...
View ArticleClik here to view.
Which medical device standard requires to have traceability between test to...
Traceability is an essential aspect of medical device development and manufacturing. It involves the ability to trace the history, use, or location of a product from its origin to its final...
View ArticleClik here to view.
What is a medical device Quality System?
Medical devices are an essential part of the healthcare system and are used to diagnose, treat, or prevent a wide range of medical conditions. Because of their critical role in patient care, medical...
View ArticleClik here to view.
5 tips helping evaluate RISK using ChatGPT
Today RISK assessment results There are several reasons that medical devices may be recalled. While the implications are severe and may result in loss of life or financial depths, this article is...
View ArticleClik here to view.
Orcanos eDHR functionality Is Now Available in MES Manufacturing Module
Operation users have unparalleled visibility into the production line to increase productivity. Orcanos, a leading SAAS provider of electronic quality management system (eQMS) and application...
View ArticleClik here to view.
21 CFR part 11 vs. EU Annex 11
INTRODUCTION The United States Food and Drug Administration (FDA) and the European Commission have defined regulations for the conditions under which regulated companies can submit electronic records...
View ArticleClik here to view.
Effective baseline management for ORCANOS | ALM Requirements, Test, Defect...
ORCANOS | ALM versions and baseline management have similar behavior as a source control, thus provides powerful and intuitive tools to manage, reuse and track data records accorss versions, offers a...
View ArticleClik here to view.
What’s the best 5 eQMS software in 2023?
An electronic Quality Management System (eQMS) can be beneficial for many reasons, including: Improved efficiency and productivity: An eQMS can streamline quality processes, automate workflows, and...
View Article