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CPV Programs development

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
DIGITAL CPV
CPV Programs development

How to set up a Digital CPV plan in 3 steps.

Having a CPV Plan brings you a lot of benefits! Benefits that include real-time monitoring of your products’ quality, an effective and consistent control strategy and signalling the discovery opportunities for process improvement.   You’d think that everyone would have implemented CPV Plans by now, but that’s not (yet!) the case. Read more…

By 4TE Team, 3 monthsFebruary 4, 2022 ago
DIGITAL CPV
CPV Programs development

Manual CPV vs Digital CPV: Why should you upgrade?

In our last blog posts about Continued Process Verification (CPV) you were able to know the benefits, challenges, and even how to do a CPV Implementation. However, there’s a lot to consider when it comes to take the step into Digital Continued Process Verification.  That’s why it is important to Read more…

By 4TE Team, 8 monthsSeptember 23, 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
CPV Implementation
CPV Programs development

CPV Implementation: why is it important?

Continued Process Verification (CPV) is the continued collection and analysis of data that assures your process is in a state of control. CPV Implementation is important because you can then monitor product quality in real-time. Efficiently. In this blog post we write about why implementing a CPV plan in your Read more…

By 4TE Team, 9 monthsAugust 27, 2021 ago
data integrity
CPV Programs development

Data Integrity in Healthcare

With a new guidance on Data Integrity (DI) being prepared by the World Health Organization (WHO) to replace its previous one, this is a good time to look at Data Integrity in Healthcare! On that note, keep in mind that regulatory agencies also have their own guidelines: European Medicines Agency Read more…

By 4TE Team, 1 yearApril 19, 2021 ago
Recent Posts
  • Digital Transformation: Impacting Global QRM
  • How to support global manufacturing of pharma products
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  • Business Continuity in Pharma: the role of Risk Management
  • QRM System for ATMPs: time to make it digital
Category
  • 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)
  • Development of Quality by Design Frameworks (6)
  • 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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