If you place a medical device on the market your company must comply with the relevant legislation and corresponding processes. In order to gain access in Europe your company must follow the current European Commission framework which is...
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KVALITO Consulting
Cloud-Sicherheit in der regulierten Life-Science-Industrie
Die Sicherheit von Cloud-Lösungen ist ein wichtiges Thema in nahezu allen Wirtschaftsbereichen, jedoch gelten für die Life-Science-Industrie hier besondere Anforderungen, da dieser Wirtschaftszweig Patientendaten und geistiges Eigentum...
FDA approves first ever 3D Printed Drug
The FDA has approved the first ever drug created via 3D Printing technology, a decision which can lead to a new era of drug manufacturing. The drug controls seizures called Spritam, manufactured by Aprecia Pharmaceuticals. FDA have also...
Sponsored by KVALITO Scenario Planning – How to Think Differently About the Future
Event description As leaders and managers, you are feeling the constant pressure of global competition and unrelenting changes that are taking place in your business landscape. Your challenge is a difficult one: to formulate strategies...
Data Privacy In The Age Of Digital Health
What do you think is the most valuable asset of every patient in the world? The thinking behind this question is shown in the implementation of digital health functions and solutions in the company and its products. The most valuable...
Compliance für die Gesundheit 2.1
Durch neue technische Entwicklungen wird der Traum von der personalisierten Medizin langsam aber stetig Wirklichkeit. Themen wie Digital Health und Industrie 4.0 spielen hier eine wichtige Rolle, denn erst durch die Vernetzung beider...
A Master Data and IDMP Compliance DEADLINE!
Author: KVALITO Consulting Group
Stricter… Harsher… Narrower…? GMP guide improvement of best practices in the area of Quality
The pharmaceutical industry is a highly regulated and controlled sector of economy. Development, manufacturing, and management of medical products are carefully examined and analyzed in order to ensure amenability with present...
The clock is ticking! From planning to execution: e-pedigree and serialization
“The price of no action is far greater than the cost of a mistake” ― Meg Whitman FDA regulations State governments, federal agencies and the pharmaceutical industry started a real war against counterfeiting and diversion. Track and trace...
Do It Better And Faster – Batch Management & Global Batch Traceability
"Quality is everyone's responsibility" - W. Edwards Deming Batch: Material or Product Quantity with similar characteristics Global Batch Traceability (GBT) is a SAP application, which operates across various systems and products. It...
Keep Calm and Stay Patient… So Much More Is Coming! -“FDA and the Drug Quality and Security Act”
“Companies spend millions of dollars on firewalls, encryption and secure access devices, and it’s money wasted, because none of these measures address the weakest link in the security chain". – Kevin Mitnick ...
DIA Annual Clinical Forum
Eice(BYOD). There are advantage and disadvantages for provisioned and BYOD mobility. What is the future? Its predicted that technology will exist within the next 5 years that projects the full vital signs of patients. From a regulatory...
Implemention a Smart Quality Management System
“Quality is never an accident; it is always the result of high intention, sincere effort, intelligent direction and skillful execution; it represents the wise choice of many alternatives.” ~William A. Foster Implement A Quality Management...
The Supply Chain – the Backbone of a Pharma Company! -Track&Trace
“Heroes may win battles, but it is capable supply chains that win wars” - Natalie Privett Many firms have been trying to discover, develop and market medicine more economically and efficiently. Unfortunately, relatively little effort was...
Good Distribution Practice: Brief Overview
"In theory, there is no difference between theory and practice. In practice there is." - Yogi Berra Good distribution practice, also known as GDP, was originated by the World Health Organisation (WHO) and the European Economic Community....
GxP Compliance: Back To Basics
If a drug is being produced in a GxP compliant manner, there are various specific guidelines that must be adhered to. In principle, computer systems associated with the life cycle of a product must meet certain criteria. The...
OpenFDA Website Launch
The FDA has recently launched an online research project which is still in beta. However, this is not for clinical use as stated on their website: https://open.fda.gov/ The webpage is very user friendly as it is based on a simple lay out...
2014 PDA Europe Conference on “Outsourcing/Contract Manufacturing” in Berlin
On December 2-3 the Parenteral Drug Association (PDA) held a conference on “Outsourcing/Contract Manufacturing” in the heart of Berlin. Two team members represented KVALITO at the discussions about the focal question: “Is Outsourcing your...
15th DIA Conference on European Electronic Document Management
Two of our consultants recently represented KVALITO at the 15th DIA Conference on European Electronic Document Management, held on December 2-3 in Berlin, Germany. A wide range of interested parties attended the conference, from big...
Digital Health Compliance
“I think the biggest innovation of the 21st century will be at the intersection of biology and technology. A new era is beginning” Steve Jobs On the Brink of Innovation You might not know it yet,but you are living in the digital era. You...
