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Quality Risk Management Digitalization

Quality Risk Management Digitalization

Business Continuity in Pharma: the role of Risk Management

Recent world events have been showing pharma companies the importance of having an effective business continuity plan (BCP). Risk management is a crucial part of the business continuity plan, but it can be a challenge for the pharma industry, given the complexity of the supply chains. One example that is Read more…

By 4TE Team, 1 monthApril 6, 2022 ago
PACM Protocol
Quality Risk Management Digitalization

Creating a Post-Approval Change Management (PACM) Protocol

Making Post-Approval Changes can be a challenge. You have different timelines, different submission requirements and trouble optimising your processes. Because of that, this makes the knowledge of creating a post-approval change management (PACM) protocol all the more important. And that’s what this blog post is all about! In it, we’ll Read more…

By 4TE Team, 8 monthsSeptember 23, 2021 ago
subjectivity in risk assessements
Quality Risk Management Digitalization

Subjectivity in Risk Assessments: a hot topic

Subjectivity in Risk Assessments and Quality Risk Management (QRM) outputs has been under the spotlight recently. In this post we will explore why, how, and what are the tools that you can use to minimize it. Current regulatory context Since the publication of ICH Q9 in 2005, it became the Read more…

By 4TE Team, 9 monthsAugust 10, 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
Cell and Gene Therapies featured image
Development of Quality by Design Frameworks

Cell and Gene Therapies: Risk Management Processes

The Cell and Gene Therapies industry is growing at a tremendous speed, building both on innovative solutions and a solid investment by life science companies who wish to diversify their market offer. The results have been impressive and Patients who had exhausted treatment options are getting exciting new opportunities. To Read more…

By 4TE Team, 1 yearApril 1, 2021 ago
nitrosamines
Quality and Risk Management Strategy

Risk Assessment of Nitrosamine Impurities

The execution of Risk Assessment for Nitrosamine Impurities is still a hot topic, and it’s not going to cool down any time soon. Back in June 2018, a Chinese API manufacturer notified EU authorities that N-nitrosamines were identified in a batch of valsartan. Nitrosamines are a genotoxic and carcinogenic agent Read more…

By 4TE Team, 1 yearMarch 24, 2021 ago
QRM Process Optimization
Quality and Risk Management Strategy

QRM over Lifecycle Management

In this article we will discuss the ever growing importance of Quality Risk Management in the context of Lifecycle Management. Risk and knowledge management were introduced by the ICH guidelines (ICH Q8 onwards). Since then, they became increasingly appreciated and implemented through other guidance such as the EU-GMP Guidelines.  The forthcoming ICH Read more…

By 4TE Team, 1 yearFebruary 5, 2021 ago
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
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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