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ISPE Good Pratice Guide: Digital Validation

ISPE’s Good Practice Guide is out — and No deviation Is Proudly Involved

1 Comment / Blog, Digitalization, Paperless Validation, Validation /

Digital Validation Takes Center Stage April 2025 marks a major milestone in the pharmaceutical and life sciences industries: the publication of ISPE’s Good Practice Guide: Digital Validation. This long-anticipated resource provides clear, actionable guidance on transitioning from traditional paper-based validation to fully integrated Digital Validation Tools (DVTs). At No deviation, we’re particularly proud of this…

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A pharmaceutical engineer conducting GMP-compliant maintenance on manufacturing equipment, ensuring process control and regulatory compliance.

GMP-Compliant Maintenance: A Pillar of Process Control

1 Comment / Blog /

GMP-Compliant Maintenance: A Pillar of Process Control In Good Manufacturing Practice (GMP), the third phase of process validation—continued process verification—ensures that your process remains in a state of control. However, maintaining this state is not static; it requires proactive management throughout the lifecycle of your facility. From the initial equipment qualification and process validation, many changes will inevitably occur. Equipment

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Nd Conversations That Matter

Mobilizing a Digital Engineering Program: Practitioner View   

Leave a Comment / Blog, Digitalization /

Conversations That Matters No deviation’s  Takeaways from ISPE Facilities of the Future Conference in San Fransisco Mobilizing a Digital Engineering Program: Practitioner View    Speaker: Joydeep Ganguly, Gilead Sciences, Inc.   Gilead Sciences: Rebuilding for Innovation and Digital Transformation  Gilead’s ambition to lead pharmaceutical innovation drove its strategic decision to accelerate drug development and optimise operational efficiency.

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Remote Audits - Are You Ready

Remote Audits – Are You Ready?

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Auditors show they are ready for remote audits, are you? The pharmaceutical industry is undergoing a transformation in regulatory oversight, driven by the increasing adoption of Remote Audits. Both the FDA and the Pharmaceutical Inspection Co-operation Scheme (PIC/S) have recently released guidance documents highlighting their readiness and commitment to remote assessments as a permanent oversight

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Nd Conversations That Matter

Revolutionizing Pharmaceutical Manufacturing: Robotics, Teleoperation, and Digital Twins

Leave a Comment / Blog, Digitalization /

Conversations That Matters No deviation’s Takeaways from ISPE Facilities of the Future Conference in San Fransisco Shanshan Liu, our technical director and Pierre Winnepenninckx, our CEO were attending ISPE Facilities of the Future conference 2025 happening last week! Here’s a summary of the sessions they attended on Robotics, teleoperation and ditigal twins. Introduction This content summarizes

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ISPE AI Conference 2024: Key Insights and Strategies

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Introduction: The ISPE AI Conference 2024 in Gdansk, Poland, brought together brilliant minds to explore the potential of artificial intelligence in the pharmaceutical industry. Keynote speakers and attendees shared groundbreaking research, innovative solutions, and best practices for leveraging AI in drug discovery, development, and manufacturing. This blog post highlights some of the key takeaways and

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the 7 guides to unlock a successful risk based cqv project no deviation

The 7 guides to unlock a successful risk-based CQV project

Commissioning, Qualification and Validation /

Our previous post talked about the skills a CQV engineer needs. In this article, we will give you the CQV starter kit with 7 documents that will guide you in unlocking a successful risk-based CQV project. It has everything you need to understand the journey of equipment into the different phases of the project, and

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what you need to become a cqv engineer in the pharma industry no deviation

What you need to become a CQV engineer in the pharma industry

Blog, Commissioning, Qualification and Validation /

In our previous posts, we explained why there is no better time than now to work in the pharmaceutical industry. It is especially true for the year to come, if you live in Singapore or plan to relocate here. With the current COVID-19 situation, much more manufacturing power is needed, and Singapore is a unique

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