No deviation

No deviation now part of the Efor Group

No deviation Joins Efor Group to Expand Global CQV and Digital Validation Capabilities

Leave a Comment / Blog /

No Deviation, specialized in commissioning, qualification & validation (CQV) and digital validation, has joined Efor Group, a global life sciences consultancy focused on quality and compliance for the pharmaceutical, biotechnology, and medical device industries, employing more than 3,000 professionals in 18 countries worldwide. This integration strengthens No deviation’s ability to support pharmaceutical and biotechnology manufacturers…

No deviation Joins Efor Group to Expand Global CQV and Digital Validation Capabilities Read More »

When Validation Becomes the Bottleneck

Leave a Comment / Blog, Digitalization, Validation /

Why Large Capital Projects Need a Different Operating Model In large pharmaceutical capital projects, speed is always a priority. But one part of the process still tends to slow everything down: commissioning, qualification and validation. The issue is not expertise. It is the way CQV is still often organised. On complex projects, paper-based workflows, sequential

When Validation Becomes the Bottleneck Read More »

QMSR 2026

QMSR 2026 – When “Having a QMS” Is no longer enough

Leave a Comment / Blog /

For years, the question was simple. Do you have a Quality Management System? Procedures written. Deviations logged. CAPAs opened, closed, archived. Everything in place. Then, quietly, the question changed. Does this system actually work? On February 2, 2026, when the FDA’s Quality Management System Regulation (QMSR) comes into force, that nuance becomes decisive. And for

QMSR 2026 – When “Having a QMS” Is no longer enough Read More »

How to conduct an equipment FAT

A Complete Guide to Equipment FAT in GMP and Pharma Projects

Leave a Comment / 3D Model Review, Blog, Project Management /

Once the 3D model is approved, the project leaves the digital world and steps into the real one. What used to exist only on a screen is now standing in a factory, wired, piped, assembled, and ready (in theory) to do the job it was designed for. And this is where things get serious. Because

A Complete Guide to Equipment FAT in GMP and Pharma Projects Read More »

No deviation & The Kitchen Story

Designing a pharmaceutical facility is like designing a kitchen… Here’s Why

Leave a Comment / Blog, CQV Strategy, Project Management /

The kitchen Story “A pharmaceutical plant is just like a big kitchen. Our role is to help the client decide what they want to cook, choose the right equipment, install it properly, and show them how to use it. Because buying the right oven doesn’t guarantee a good pizza — you also need the right

Designing a pharmaceutical facility is like designing a kitchen… Here’s Why Read More »

Audit Readiness

Audit Readiness Is Not a Training, It’s a Culture

Leave a Comment / Audit, Blog /

If there is one truth shared across every inspection, whether in the US, Europe, or Asia-Pacific, it’s this: Audit readiness doesn’t depend on how well people repeat procedures. It depends on how well they understand them. Most organisations treat audit preparation as a last-minute exercise: refresh the SOPs, rehearse a few storyboards, tidy up documentation,

Audit Readiness Is Not a Training, It’s a Culture Read More »

Implementing A Risk-based Approach

Implementing a Risk-based Approach & Benefits and Challenges of Digital Tools

Leave a Comment / Blog, Conversations That Matters, Quality Risk Management /

Conversations That Matter No deviation’s Takeaways from 2025 ISPE Conference in Singapore Panelists: Dave O’Connor, C&Q Digital Transformation Manager, No deviation, Hazem Eleskandarani, Senior Director, Global Quality Engineering, CSL Behring, Pierre Winnepenninckx, CQV CoP Lead, ISPE Singapore Affiliate & CEO, No deviation, Sebastian Scheler, MD & Chief Methodologist, Innerspace, Yiming Peng, Global Data Science Lead,

Implementing a Risk-based Approach & Benefits and Challenges of Digital Tools Read More »

AI

AI, Punch Lists & GMP Dreams: Notes from the (Digital) Field

Leave a Comment / Ai, Blog /

There’s always that moment—usually around week two of a greenfield project—when someone gets starry-eyed and says, “What if we just let AI write the protocols?” Cue the collective nods. Cue the excitement. Cue… the same old paper-based FAT, SAT, and Excel punch list. Let’s be honest: AI-generated anything sounds sexy. But in our world—where a

AI, Punch Lists & GMP Dreams: Notes from the (Digital) Field Read More »

Quality Risk Management in Practice

ICH Q9(R1): Quality Risk Management in Practice — Why Subjectivity and Formality Still Matter

Leave a Comment / Blog, Conversations That Matters, Quality Risk Management /

Conversations That Matter No deviation’s Takeaways from 2025 ISPE Europe Annual Conference in London  Speakers: Alice Redmond – CAI, Kevin O’Donnell – Health Products Regulatory Authority (HPRA), Graham Carroll – MHRA, Arie Menachem – Novo Nordisk ICH Q9 isn’t new. Even the revision (R1) is no longer fresh off the press. But the conversations it sparks

ICH Q9(R1): Quality Risk Management in Practice — Why Subjectivity and Formality Still Matter Read More »

No deviation By Efor

SITEMAP

STAY CONNECTED

FOLLOW US

CONTACT INFORMATION

2 Venture Drive, #08-10/11,
Vision Exchange
Singapore 608526

(65) 6592 4573

hello@nodeviation.com

HR@nodeviation.com

Copyright © 2024 No deviation Pte Ltd. All rights reserved.