Kalleid Blog
Applying the GAMP5 Framework in an Agile GxP Validation Project
A risk-based approach is a cornerstone of modern GxP validation approaches. It focuses resources where they matter most, ensuring patient safety and product quality while optimizing efficiency.
GAMP 5 (Good Automated Manufacturing Practice) is a widely recognized framework for the ...
Future Trends in Biotech Project Management: Preparing for the Next Decade
As we look towards the next decade of biotech and pharmaceutical development, the landscape of project management is set to undergo transformative changes as well. Driven by emerging technologies, evolving regulatory environments, and shifting market dynamics, biotech firms and ...
Project Management Best Practices for Biotech R&D: From Concept to Commercialization
Project Management Best Practices for Biotech R&D: From Concept to CommercializationThe biotech and pharmaceutical industry is typically at the forefront of technological innovation, constantly pushing the boundaries of what is possible in medicine and science. This makes ...
Strategies for Harnessing AI-Ready Chemical Data in Drug Discovery
In drug discovery, artificial intelligence (AI) and machine learning (ML) technologies have significantly changed the way researchers analyze and interpret chemical data. From molecular modeling to predicting drug responses, AI-driven approaches offer opportunities to expedite the ...
Integrated Laboratory Instrument Management
Modern laboratories are under enormous pressure to produce research and simultaneously minimize waste and regulatory risk. One area where labs often fail to maximize operational efficiency is laboratory instrument management. Proper management of laboratory equipment through every ...
How Artificial Intelligence (AI) Can Help Technical Writers
Why AI Now?
Technical writers use several authoring applications to create technical content. They write in Microsoft Word, Adobe FrameMaker, and many content management systems like Madcap Flare. Now, we have another tool to help our writing, the messaging-like app called the AI ...
The Importance of Data Integrity in a Pharmaceutical R&D Environment
The FDA is responsible for protecting public health by ensuring that human and veterinary drugs, biological products, and medical devices are safe, effective and of high quality. Verification of data integrity is a critical aspect of this mission, and the FDA therefore expects that ...
Key Success Factors in Laboratory Instrument Management
Introduction
In today’s fast-paced world, laboratories are expected to produce research at a rapid rate. All too often, organizations attempt to face this challenge by simply purchasing faster, newer instruments and overlook the keys to successfully getting the most out of their ...
Common Change Management Challenges and How to Address Them
In August 2003, Chris De Wolfe and Tom Anderson founded Myspace, a social network they envisioned would allow ordinary music buffs to communicate with their favorite musicians. Its success was undeniable—the popularity of Myspace skyrocketed year after year following its inception. ...
Creating Product Roadmaps for Your Software Portfolio
COVID-19 accelerated the process of digital transformation for many enterprises. To meet the demands of today’s competitive business environment, organizations are integrating digital technologies and business applications at an accelerating pace. Yet with more and more project ...
The Elusive Promise of Managed Change
I love the work of change management because it is messy, unpredictable, and deeply personal. Humans, when taken individually, are complex and full of surprises. But aggregate the expected behavior of 10, 50, or even 10,000 humans and the possible outcomes are practically limitless. ...
Choosing the Right LIMS Hosting Solution for Your Laboratory
In today’s data-driven world, scientific laboratories are in a constant race to enhance their productivity while keeping up with ongoing changes in their laboratory data management needs. In order to face these challenges, organizations must determine the type of Laboratory ...
Recent Posts
Applying the GAMP5 Framework in an Agile GxP Validation Project
Strategies for Harnessing AI-Ready Chemical Data in Drug Discovery
How Artificial Intelligence (AI) Can Help Technical Writers
The Importance of Data Integrity in a Pharmaceutical R&D Environment
Common Change Management Challenges and How to Address Them
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