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Article Series Continuous Improvement in a QMS – the Fil Rouge that Connects all Quality Processes:: 2.1 The Role of the Business Process Owner Within a QMS (Part 1)
PART 1: The Importance and Complexity of the Business Process Owner Role In recent years, the pharmaceutical...

Avoid FDA Warning Letters in the Context of Computerized System Validation: A Short Guide by KVALITO
Photo by Eduardo Dutra on PexelsElevating Compliance in the Life Sciences: Navigating Computerized System Validation...

Article Series Continuous Improvement in a QMS – the Fil Rouge that Connects all Quality Processes::Continuous Improvement within a QMS
Have you ever thought about what is the ‘fil rouge’ that connects all regulations applicable to the pharmaceutical...
KVALITO Malaysia Sdn Bhd is Founded
KUALA LUMPUR, Malaysia October 29th 2020. KVALITO Consulting Group today, announced the opening of a new office...
How to conduct a Software Risk Assessment
First, the risk must be identified. It is always the same scheme; a hazard combined with a hazardous situation can...
What is Software of an Unknown Provenance known as SOUP?
International standard IEC 62304 defines life cycle requirements for the development of medical software...
Quality as a Driver in Organizations
KVALITO is a diverse company. Being a woman-owned business, we acknowledge equality and diversity in all our working...
Effective Communication
"Less is more"—Robert Browning "Andrea del Sarto" (1855) Communication truly is the engine of fruitful relationships....
How can we deal with conflict at work?
"Don't fear conflict; embrace it - it's part of your job." —Clara Sayrol When a group of people comes together,...
Good Documentation Practices in Regulated Environments
"Proper documentation is the only witness of what you have done: in its absence, you did nothing; if it is poor, you...
Meet Dimitrij Gvozdev
Meet Dimitrij Gvozdev We would like you to meet Dimitrij Gvozdev, who is passionate about working with KVALITO and the...
Digitalization of Pathology – A New Approach
Development and Validation of Digital Pathology Digital pathology means the use of technology to accelerate and...