SMART WAY OF BUSINESS

Applied Technology Innovation, Life Science and Healthcare, Transformation, Quality & Compliance Consulting

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Our Services

Audit and assessmenT

Computerized System Validation (CSV) and Good Manufacturing Practices (GMP) audits conducted by experts to assess your tools and products.

TRANSFORMATION AND CHANGE MANAGEMENT

Changes to corporate strategy, implementation of new technologies, setting up communication protocols, effective risk management, documentation and more.

 We don’t just tell you what to do, we help you get there.

SMART QUALITY & COMPLIANCE

We build global and local regulatory requirements and industry standards into business processes to build trust with regulators. Low operations impact, high quality outcome.

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Strategy and Advice 

Market innovations and regulation changes are major drivers for improvement in the life science and healthcare industries. Our consultants will adapt your business and digital strategy to keep you ahead of the pack at all times.

Business Excellence and improvements

Our holistic service approach identifies business needs, determines solutions to your business problems and implements governance frameworks and quality checks for guaranteed compliance.

Special Expertise

With decades of experience in Life Science and Healthcare Fortune 500 companies, we offer consultants and even interim management to help create a culture of excellence from within.

Our Commitment

KVALITO has been a member of the UN Global Compact since 2016 and we commit to uphold quality and compliance industry standards to the highest degree

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From our blog

Precision Medicine

Precision Medicine Precision medicine, also known as personalized medicine, is an approach to developing safer novel therapeutics that integrate genomics and big data (genetic, clinical, molecular, diagnostic and environmental data) to detect pathogenic events at the...

How is a system validated?

Definitions from ISO 9000:2005, revised by ISO 9000:2015 Quality management systems – Fundamentals and vocabulary.  AVerification: Confirmation, through the provision of objective evidence, that specified requirements have been fulfilled.Validation: Confirmation,...

What is a software product framework?

A software product framework is a set of software units assembled in a software item. The collective software items form the software system. The software system, together with the packaging and the instruction for use, shape the software product....

Usability and Labelling

What is usability ?   The new Regulation, MDR, strengthens the rules regarding labelling and usability.   Usability is the characteristic of the user interface that facilitates use and establishes effectiveness, efficiency...

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 practices. We support our entire team to achieve success within their projects and their career development. After all, without excellent consultants,...

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 did a poor job no matter what you really did." —Marco Polisena Introduction Good Documentation Practices (GDP) has evolved to be one of the essential...

Digitalization of Pathology – A New Approach

Development and Validation of Digital Pathology Digital pathology means the use of technology to accelerate and improve the workflow in pathology laboratories. It focused on data management based on information generated from digitized specimen slides by using virtual...

Risk-Based Computerized System Validation (CSV) and Computer Software Assurance (CSA) – Old Wine in a New Bottle?

“Discovering the unexpected is more important than confirming the known.” —George Box, Stuart Hunter, and William G. Hunter Introduction The World Health Organisation (WHO) specifies that “the purpose of validation is to confirm that the computerized system...

What is the development lifecycle of a Medical Device?

What is the development lifecycle of a Medical Device? Figure 1: Medical Device development lifecycle. Adapted from ISO 13485:2016. Copyright 2020, Kvalito Consulting Group.   First and foremost, the user requirements need to be defined by the organization....

LIMS Implementation: Success Factors from a Project Manager Perspective

"Change before you have to." —Jack Welch A Laboratory Information Management System (LIMS) is software that allows your laboratory to manage samples and associated data effectively. Its primary purpose is to improve lab efficiency and accuracy by reducing manual...

Stay Safe and Healthy

Even in the current situation, KVALITO Consulting Group is actively contributing to the economy, continuing to turn and to be able to respond flexibly to customer needs at any time.  We are...

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2016 – 3 years KVALITO Consulting Group!

“Every journey of a thousand miles begins with a single step.” (Lao Tzu) Please join us in celebrating this milestone which started three years ago as a great journey. We must be proud of what we...

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Kvalito Ireland Limited is Founded

  KVALITO set-up new SMARThub to be closer to and support our client in Western Europe. KVALITO Ireland supports KVALITObase  and regional management in delivering KVALITO services to our...

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From the Press

AHK Malaysia

AHK Malaysia

Over 60% of the global population is located in the APAC region, which is emerging as a considerable commercial opportunity for biopharma, pharmaceutical, medical device, and healthcare companies. With ongoing reform to healthcare systems in progress, the outlook for...

Vision talk with Daniel Eisenhut:

Vision talk with Daniel Eisenhut:

VISIONTALK with Magdalena Kurpierz CEO of @KVALITOCONSULTING We talked about "just doing the work" and how Covid can be actually a chance for humanity Interview here https://www.instagram.com/tv/CKCfTK8H6Ya/?igshid=bwakbglq7uwc

The MGCC® Podcast

The MGCC® Podcast

2% of CEOs in Switzerland are women. Magdalena Kurpierz is one of those few female CEOs and she explains why diversity and inclusion are good for business. As founder of the successful life science and healthcare consulting company Kvalito she proves that she is on...

CNN money

CNN money

We are proud to announce that our CEO Magdalena Kurpierz has been interviewed by CNNMoney.  Full interview herehttps://lnkd.in/gcPjt6n