Posts Tagged ‘Quality Management’
Referenzen : Axomove
“Our collaboration with wega enabled us to easily implement and validate a very nice, user-friendly and affordable electronic quality management system compliant to ISO13485 and accordingly close a corresponding opened non-conformity. wega also consulted us on how to best document our Software Development in accordance with IEC62304 by leveraging Jira and maintain our technical documentation…
Read MoreThe EU AI Act – Its potential impact on the Pharma Industry
The EU AI Act is a regulation brought up by the EU in response to the boom in AI use through the world and across all industries, enabling the use of AI in a very easy and accessible manner to the General Public.
Read MoreThe IT Odyssey of a Lab Head
It all began with a seemingly straightforward request:
“We need to validate a new quality control analytical method for DNA analysis.”
Dr. D., the Lab Head, immediately thought of the DNA-Saur, an instrument stored in the basement since a previous proof-of-concept initiative. At that time, only high-level requirements had been defined, and initial steps were taken to explore the experimental setup.
Read MoreRemediation of Medical Device Design History File
This white paper addresses the issue of DHF debt and how to resolve this debt through DHF remediation. It also addresses the reasons for DHF debt and best practices for effective remediation.
Read MoreWhy CI / CD Significantly Improves Your SaMD / MDSW Development Process
When developing standalone medical device software or software that is part of a hardware medical device, it is essential to have control over your code.
Read MoreImportance of Data Archival in a GxP-Regulated Environment
In analytical and industrial scientific research laboratories generation of comprehensive analytical data is a main purpose to serve scientific goals.
Read MoreWhy You Should Prefer Modern Tools to Traditional Methods for Creating CSV Documents
This article looks at the benefits and challenges of introducing modern documentation tools for CSV and highlights their role in simplifying processes, reducing errors and improving traceability…
Read MoreMathias
Scrum Master
Scrum Trainer
Agility Coach
wega Breakfast – Navigating CSV in a S/4HANA Brownfield Transition
05 Dec 2024
This presentation examines the approach Medartis AG adopted for Computer System Validation (CSV) during its SAP S/4HANA brownfield transition.
Electronic Signatures in Laboratory Systems – Are the Regulatory Requirements Enough?
In an industry that relies heavily on precise documentation, strict compliance, and rigorous regulatory oversight, the implementation of electronic signatures represented a powerful leap forward.
Read MoreChristophe
Managing Director
Board of Directors
CSV & QA
Evelyne
Managing Director
Senior Consultant
CSV Specialist
Why do we need to automate software tests for user requirements?
At wega, there are many activities related to software validation…
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