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Top 5 tips for implementing test management successfully in your organization
Test management improves Application Lifecycle Management (ALM) and Design Control (ISO 13485 Clause 7) process, by providing a systematic approach to planning, designing, executing, and reporting on...
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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...
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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...
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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...
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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 ArticleWHITE PAPER ACHIEVING ISO 26262 COMPLIANCE WITH ORCANOS ALM and QMS
ISO 26262 is an automotive standard that places requirements on the quality of software, for which tools such as ORCANOS ALM and QMS are ideally positioned to enforce. With the highest adoption in the...
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Effective baseline management for ORCANOS | ALM Test Management
ORCANOS | ALM versions and baseline management have similar behavior as a source control, thus provides powerful and intuitive tools to manage and track versions, provides a full change history,...
View ArticleHow to go About Good Practice in Validating Computer Systems in a Regulated...
Overview Computer System Validation is the technical discipline that involves the use of life sciences companies, to ensure applications provide the information they were intended to. FDA monitoring...
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Elcam Medical Mitigating The Approval Risk – By Placing their documents on...
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...
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cGMP – Design and Development Master Validation Plan (10)
People in the medical device industry are often wary of the term validation even though they shouldn’t. Validation is using objective evidence and experiment to ensure that a set of requirements are...
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cGMP – Medical Equipment Calibration – How it affect our success – ISO...
Calibration is considered as an essential procedure for any equipment and device, in order to maintain and improve its accuracy and precision. Calibration is the process, in which equipment under test...
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cGMP – Design and Development Outputs (SwRS-MecRS-HwRS-FwRS) – ISO 13485:2016...
In the same manner that we have design and development input. We also have design and development output. The result of satisfying the criteria for design input is the design output. The output will...
View ArticleWHITE PAPER ACHIEVING ISO 26262 COMPLIANCE WITH ORCANOS ALM and QMS
ISO 26262 is an automotive standard that places requirements on the quality of software, for which tools such as ORCANOS ALM and QMS are ideally positioned to enforce. With the highest adoption in the...
View ArticleClik here to view.
Effective baseline management for ORCANOS | ALM Test Management
ORCANOS | ALM versions and baseline management have similar behavior as a source control, thus provides powerful and intuitive tools to manage and track versions, provides a full change history,...
View ArticleHow to go About Good Practice in Validating Computer Systems in a Regulated...
Overview Computer System Validation is the technical discipline that involves the use of life sciences companies, to ensure applications provide the information they were intended to. FDA monitoring...
View ArticleClik here to view.
Elcam Medical Mitigating The Approval Risk – By Placing their documents on...
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...
View ArticlePreventing Potential Recall by Testing Right Your Product
On the QA Geek Week giving the following lecture based on a selected example of recalls researched by Orcanos to provide some preventive actions methods on the validation and verification methodology....
View ArticleWHITE PAPER ACHIEVING ISO 26262 COMPLIANCE WITH ORCANOS ALM and QMS
ISO 26262 is an automotive standard that places requirements on the quality of software, for which tools such as ORCANOS ALM and QMS are ideally positioned to enforce. With the highest adoption in the...
View ArticleClik here to view.
Effective baseline management for ORCANOS | ALM Test Management
ORCANOS | ALM versions and baseline management have similar behavior as a source control, thus provides powerful and intuitive tools to manage and track versions, provides a full change history,...
View ArticleHow to go About Good Practice in Validating Computer Systems in a Regulated...
Overview Computer System Validation is the technical discipline that involves the use of life sciences companies, to ensure applications provide the information they were intended to. FDA monitoring...
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