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Risk Management Digitalization

Digital Transformation: Impacting Global QRM

When we discuss Quality Risk Management, we often focus on the operation, shop floor side of the processes. Today we’ll talk about some of the key aspects of QRM for the top-tiers of the Pharmaceutical Companies and how bringing the digital transformation to Global QRM can have a major impact. Read more…

By 4TE Team, 11 hoursMay 18, 2022 ago
Comparability Studies

How to support global manufacturing of pharma products

The success of a globalisation strategy relies on a key pillar: process and product performance comparability. This is so because global pharma companies require flexibility to produce the same product across a network of manufacturing sites and locations.  For this blog post, we’re going to offer our perspective on how to handle Read more…

By 4TE Team, 2 daysMay 16, 2022 ago
Cell & Gene Therapy

QRM System for ATMPs: time to make it digital

The last few years have been full of advances in the field Advanced Therapy Medicinal Products (ATMPs). And, as any products that interfere in the health and well-being of patients, it requires a Quality Risk Management System. Which brings us to this blog post: why a Digital QRM System for Read more…

By 4TE Team, 1 month ago
ICH Q13 CM
Continuous Manufacturing

The new ICH Q13 Guideline is almost here!

The new ICH Q13 guideline is almost here! The guideline on continuous manufacturing (CM) is currently under public consultation and the general deadline for comments is end of 2021. We, as 4TE, have been actively involved on the public consultation phase. And, because of that, we thought of talking a Read more…

By 4TE Team, 6 monthsNovember 22, 2021 ago
cpv plan
CPV Programs development

CPV Implementation: how to do it?

In our recent blog post we talked about the benefits and challenges of Continuous Process Verification (CPV) Implementation. We hope you’re convinced! This time we want to talk about how to do a CPV Implementation. CPV implementation requires that, first, you use a well thought logic and rationale that we Read more…

By 4TE Team, 9 monthsSeptember 1, 2021 ago
Process Scale-up

Tech Transfer: Planning for Success

Tech Transfers, or Technology Transfers, usually imply that you’re moving the manufacture of a drug from one facility, one scale or one drug lifecycle phase to another. Which is why they are so important. When you switch facilities, you want to transfer the knowledge and reproduce the process smoothly. The Read more…

By 4TE Team, 11 monthsJune 16, 2021 ago
Comparability Studies

Comparability for Post-Approval Changes

Today we want to take a fresh look into comparability for post-approval changes. How? We’re thinking of a unique multiparametric approach. This approach is aligned with the FDA’s tiered and totality-of-evidence concepts in biologic development. These concepts are helpful to compare biosimilar and reference products. But they can go beyond Read more…

By 4TE Team, 11 monthsJune 13, 2021 ago
Knowledge Management

KASA Initiative: Enabling knowledge in Industry

One of the goals of industry 4.0 is to achieve end-to-end digital process integration. In this post we’ll talk about the KASA Initiative and how it enables knowledge. And then, how that knowledge supports process monitoring, control and understanding. This can be achieved through a complete data knowledge dimension, from Read more…

By 4TE Team, 12 monthsMay 27, 2021 ago
R platform Pharma
Custom-made Software

Building a custom-made platform for Pharma: a 4TE story

When we look at the future, as 4TE, we believe there is an area that gets more important by the day: Building Custom-made Platform for Pharma. To do this in an Agile way, it implies that we develop prototypes swiftly for these digital solution projects. We do that in R. Read more…

By 4TE Team, 12 monthsMay 25, 2021 ago
CSV to CSA
Computer System Validation

Transitioning from CSV to CSA

Changes are challenging, and in the digital world what we see the most are changes due to the continuous development of new technologies and concepts. Let’s look back at the Computer System Validation (CSV) history. Back in the 90’s, the FDA started to increase their expectations regarding computer system compliance Read more…

By 4TE Team, 1 yearMay 13, 2021 ago

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Recent Posts
  • Digital Transformation: Impacting Global QRM
  • How to support global manufacturing of pharma products
  • Cell and Gene Therapy: the benefits of PAT and QbD
  • Business Continuity in Pharma: the role of Risk Management
  • QRM System for ATMPs: time to make it digital
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  • Biossimilarity Studies (2)
  • Cell & Gene Therapy (4)
  • Comparability Studies (4)
  • Computer Software Assurance (1)
  • Computer System Validation (2)
  • Continuous Manufacturing (5)
  • CPV Programs development (6)
  • Custom-made Software (1)
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  • Digital Twin (2)
  • End-to-End Process Troubleshooting (1)
  • Knowledge Management (2)
  • News (20)
  • PAT Integration (3)
  • Process Scale-up (2)
  • Product Lifecycle Management (3)
  • QRM Summit (1)
  • Quality and Risk Management Strategy (6)
    • Medical Cannabis (1)
  • Quality Risk Management Digitalization (7)
  • Risk Management Digitalization (1)
  • Risk Management Process Optimisation (1)
  • Risk Management Process Optimization (6)
  • Root-Cause Analysis (2)
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4Tune Engineering provides 4.0 Intelligent & Integrated solutions to support Pharma and Biopharma Industries' Digital Transformation. Focused on operational excellence, we assist companies improve decisively the entire life cycle of their products and processes. Founded in 2004 with offices in Lisbon and São Paulo.




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