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A Blog about 4.0 Intelligent & Integrated solutions for Pharma and Biopharma Industries' Digital Transformation.

Comparability Studies

Advanced Comparability: 5 steps to demonstrate equivalence

Changes are inevitable throughout the lifecycle of a pharmaceutical product, and we know that whether it is to maintain product quality, efficacy or to follow regulatory requirements, these changes bring additional challenges. As such, having a consistent comparability assessment is Read more…

By 4TE Team, 2 weeksJanuary 19, 2023 ago
Quality Risk Management Digitalisation

The role of Digital QRM on your Business Continuity Plan  

Drug shortages have been a growing worldwide issue in recent years and represent a significant negative impact on patients’ lives. As we saw during COVID-19 and now, with Russia-Ukraine war, pharmaceutical manufacturing and distribution are facing many challenges. However, the risk Read more…

By 4TE Team, 1 monthDecember 27, 2022 ago
Continuous Manufacturing

Using PAT to support Continuous Manufacturing

In one of our latest blog posts we talked about the importance of real-time monitoring to keep Continuous Manufacturing in stable conditions, and we briefly discussed the usage of PAT tools to achieved that. Today, we’ll take a closer look Read more…

By 4TE Team, 1 monthDecember 21, 2022 ago
Process Digitalisation

Electronic Batch Records – how to make your operations more efficient

Keeping batch records is a matter of compliance. You need to keep (and provide) the entire manufacturing history of every batch that has come out of your facilities. Using an electronic batch record (EBR) system helps streamlining your procedures, boost Read more…

By 4TE Team, 2 monthsDecember 16, 2022 ago
Continuous Manufacturing

Using Digital CPV to support Continuous Manufacturing 

Continuous manufacturing is the future for the Pharma and Biopharma industry. It can bring many benefits to your processes (and ultimately, the business) as it lowers production costs, reduces time to market and improves medicine availability to patients.   Despite these Read more…

By 4TE Team, 2 monthsDecember 6, 2022 ago
Computer Software Assurance

Using Digital QRM to support CSA implementation 

CSA is an easier and less-resourceful way to validate your computer software. The good news is that if you already use a Digital QRM system you’re one step closer to easily implement CSA.   Let’s see! Imagine that you have something Read more…

By 4TE Team, 2 monthsNovember 29, 2022 ago
Quality and Risk Management Strategy

Efficiency & Effectiveness: How to design a control strategy for analytical procedures

As you probably already know, the new ICH Q14 guideline proposes science and risk-based approaches for developing and maintaining analytical procedures. To ensure they perform as expected we must have an efficient control strategy. If you want to know how Read more…

By 4TE Team, 3 monthsNovember 7, 2022 ago
Computer Software Assurance

How can CSA simplify your Validation processes 

Last month, the FDA issued the draft of a new guidance for Computer Software Assurance (CSA) for computers and automated data processing systems. The goal? To describe how can CSA simplify your Validation process.  Let’s dive on what is it Read more…

By 4TE Team, 3 monthsNovember 3, 2022 ago
Validation

How to improve business efficiency with digital validation   

Validation is a process that, for many companies, remains manual despite having high costs, causing errors, and being crowded with inefficiencies.    In this blog post we’ll share how to improve your validation process efficiency by moving to digital validation. Read more…

By 4TE Team, 3 monthsOctober 26, 2022 ago
Development of Quality by Design Frameworks

How to align Analytical QbD with the new ICH Q14?

The new ICH Q14 introduces the concept of an enhanced approach for the development of an analytical method. In this approach the analytical procedure is well understood and fit for intended purpose, following a Quality by Design (QbD) approach. However, Read more…

By 4TE Team, 4 monthsOctober 18, 2022 ago
Recent Posts
  • Advanced Comparability: 5 steps to demonstrate equivalence
  • The role of Digital QRM on your Business Continuity Plan  
  • Using PAT to support Continuous Manufacturing
  • Electronic Batch Records – how to make your operations more efficient
  • Using Digital CPV to support Continuous Manufacturing 
Category
  • Bioequivalence studies (1)
  • Biossimilarity Studies (5)
  • Cell & Gene Therapy (4)
  • Comparability Studies (7)
  • Computer Software Assurance (3)
  • Computer System Validation (3)
  • Continuous Manufacturing (7)
  • CPV Programs development (7)
  • Custom-made Software (1)
  • Development of Quality by Design Frameworks (9)
  • Digital Twin (2)
  • End-to-End Process Troubleshooting (1)
  • Knowledge Management (2)
  • News (21)
  • PAT Integration (4)
  • Process Digitalisation (3)
  • Process Scale-up (3)
  • Product Lifecycle Management (3)
  • QRM Summit (1)
  • Quality and Risk Management Strategy (9)
    • Medical Cannabis (1)
  • Quality Risk Management Digitalisation (13)
  • Risk Management Digitalisation (5)
  • Risk Management Process Optimisation (3)
  • Risk Management Process Optimization (6)
  • Root-Cause Analysis (2)
  • Uncategorized (1)
  • Validation (1)
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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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