Table of Contents Ancillary or Raw Materials AM qualification Conclusion Regulations References These days, research and development of many pharma companies are focused on Cell and Gene Therapies, which bring hope for many...
INSIGHTS
SMART events
SMART news
SMART Life Science
SMART Career
SMART Corporate Citizenship and Social Responsibility
KVALITO Consulting
Validation of a Bayesian Multilevel Monitoring System (BMMS)
KVALITO recently supported its pharmaceutical client in implementing and validating their Bayesian Multilevel Monitoring System. The Bayesian Multilevel Monitoring system monitors the safety of clinical trials in Oncology Biometrics and...
Data Protection Day, Data Privacy Day: 28 January 2023
"Privacy is Paradise." — Holly Hunter.On January 28th 1981, the Council of Europe adopted Convention 108 as its first legal instrument for data protection. Data Protection Day (in Europe) /Data Privacy Day (rest of the world) aims to...
KVALITO Donates to its Partner WCC (The Women’s Centre for Change) December 2022
Selvi Nadarajan (KVALITO Director APAC) journeyed to Penang, Malaysia, in December 2022 to meet the WCC team, learn about their latest activities and make a donation! Selvi reports: “I was privileged to be hosted by CK and the team to...
KVALITO donates to ZI (Zentralinstitut für Seelische Gesundheit) Förderkreis Kinder- und Jugendpsychiatrie Mannheim e. V. December 2022
Our colleagues Barbara Stroh and Julia Jornitz travelled to Mannheim, Germany, to visit the ZI team at the hospital. It was an eye-opening experience for them to go on a personal tour of the facilities and learn about current...
HAPPY HOLIDAYS 2022!
Dear clients, business partners and friends, as this year draws to a close, KVALITO wants to say a big THANK YOU to all our clients, business partners and friends for your continued trust and collaboration. It means a great deal to us...
Computerised System Validation vs Computer Software Assurance by the Example of ERP System Validation
The pharmaceutical, biotech, and medical device industries are subject to strict health authority regulations to protect data integrity, product quality, and patient safety. Validation of computerised systems is crucial for nailing these...
Internship Report
Jocelin Chee I was super excited when I found out that I would be doing my internship at KVALITO. I looked forward to the new learnings I would be exposed to, through the opportunity to work with prominent clients in the pharmaceutical...
Business Case: Commissioning, Qualification, and Validation (CQV) for Facility, Manufacturing, and Laboratory Equipment and Systems
Pharmaceutical and Medical Devices KVALITO’s highly experienced CQV Subject Matter Experts perform Commissioning, Qualification and Validation activities for systems, equipment and laboratories in the life science sectors using industry...
At HBA’s momentous APAC launch event, 2.12.2021! It is a pleasure to announce that Selvi Nadarajan, KVALITO Director APAC is on the newly formed Member Engagement Committee for the Asia Pacific region. This group creates a sense of...
A Buzzing Event, Smiling Faces, a Fundamental Cause
"The quality, relevance, and impact of the products and services output by the technology sector can only be improved by having the people who are building them be demographically representative of the people who are using them." Tracy...
HBA’S official launch in Asia Pacific on 2.12.2021
Join us! Increase your visibility. Advance your career. Get connected to our fast-growing network Free Entry All are welcome to join! Register
Meet & Greet WIT Event
Ladies and Gentlemen, it is our pleasure to invite you to our Meet & Greet WIT Event Switzerland! WHEN: October 21st 2021, 6:30 pm WHERE: KVALITO AG, Dornacherstrasse 101, 4053 Basel (5 minutes walk from SBB). We have a limited...
Internship Report
Saadia Raymode I started my internship at KVALITO in June 2021, just after my final year exam for my University degree in Malaysia, and then continued it in my home country – Mauritius. Despite not being able to go to the office, I always...
Business Case: Global Project Management in Regulatory Affairs
KVALITO supports Life Science companies in leading global cross-functional mergers and acquisitions, GMP, Regulatory and Clinical programs and operations in various project stages, including Drug Discovery, Preclinical, Clinical,...
Top 5 GxP Controls
The quality and safety of a product have always been one of the biggest concerns in the pharmaceutical industry. To address this, GxP was established and its compliance is mandatory in the healthcare environment. The GxP is a generic...
So long Jasmine, wishing you all the best!
So long Jasmine, we wish you all the very best! Jasmine Lee recently graduated with her PhD in Medical Biochemistry. She has been a great asset to our clients and our team, and we will surely miss her! Jasmine's positive can-do attitude...
Business Case: Automation of Software Development Life Cycle (SDLC)
Automation of Software Development Life Cycle (SDLC) FDA's Center for Devices and Radiological Health (CDRH) intends to publish a new guideline in the Fiscal Year 2021 (FY 2021) [R1]; "Computer Software Assurance (CSA) for Manufacturing,...
Can the Use of Unlicensed Font on your Website, Marketing Materials, or Packaging amount to a Copyright Breach?
"Type designers are, at their best, the Stradivari of literature: not merely makers of saleable products, but artists who design and make the instruments that other artists use." ― Robert Bringhurst A...
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...
