We Know What We Want! Why Write Requirements? The latest Spectroscopy Focus on Quality column has just been published and is co-authored with #MonikaAndraos. The column was triggered by a post Monika…
LinkedIn Content Strategy & Writing Style
Owner, McDowall Consulting and Pharmaceuticals Consultant NOT a Recruitment Agency
1 person tracking this creator on ViralBrain
Bob McDowall positions himself as a blunt, highly technical contrarian within the pharmaceutical consulting space, explicitly distancing himself from recruitment to focus on high-stakes laboratory compliance. His content strategy centers on a "no-nonsense" defense of Computerised System Validation (CSV), where he frequently deconstructs industry trends like CSA with a mix of academic rigor and sharp skepticism. What makes him notable is his refusal to adopt the sterile tone of corporate LinkedIn; instead, he uses irreverent British wit and provocative metaphors to challenge regulatory myths and "weasel words." This unique intersection of deep GXP expertise and a colorful, almost subversive personality allows him to transform dry topics like SaaS validation and user requirements into engaging, high-value debates for his technical audience.
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We Know What We Want! Why Write Requirements? The latest Spectroscopy Focus on Quality column has just been published and is co-authored with #MonikaAndraos. The column was triggered by a post Monika…
Visit to Glasgow Recently my wife and I visited Glasgow. In the Kelvingrove Art Museum and Museum, we were amazed to find a specimen of a very rare Scottish mammal. The haggis. This mammal only inhab…

Looking forward to speaking at Pittcon Conference + Exposition 2026 next week in San Antonio, Texas, USA. I’ll be presenting in the session Regulatory and Quality Impacts of Recent Changes in ICH, Co…

📚 Overview of all ECA Foundation Interest Groups' Guides and other Documents The ECA Foundation's Interest Groups regularly report on the projects, guides and documents they have continuously been…

1/4. Dracula Rises From The Grave: CSA Lives On? This month’s Focus on Quality column in Spectroscopy on-line reviews the latest of FDA’s final, final Computer System Assurance (CSA) guidance issued…
Not for the faint of heart or those of a nervous disposition - especially if you are a Computer Software Assurance (CSA) devotee - we consider how easy is it to adapt the final versions of the CSA gui…
1.5 posts/week
Posts / Week
1
Total Posts Analyzed
LOW
Posting Frequency
55.9%
Avg Engagement Rate
STABLE
Performance Trend
850
Avg Length (Words)
HIGH
Depth Level
ADVANCED
Expertise Level
0.85/10
Uniqueness Score
YES
Question Usage
0.7%
Response Rate
Writing style breakdown
<start of post>
The Ghost of Validation Past: Why We Still Fear Change
I was recently reviewing a validation plan that looked like it had been carved into stone tablets during the Bronze Age. It was thick, heavy, and entirely useless.
Does this sound familiar? You’re staring at a mountain of paperwork for a simple software update. The 'don't touch it' crowd is screaming in your ear. Will this be another case of death by documentation?
A validation strategy should be a sharp tool, not a blunt instrument. It protects your data by focusing on what actually matters—not by generating a forest's worth of paper to satisfy a 'holy cow' requirement that doesn't exist.
Regardless of the system, you need a sensible approach involving the people who actually use the software: lab staff, QA, and IT. Critically, management must stop seeing validation as a 'check-the-box' exercise. No more wasting weeks on testing functions that your supplier has already verified a thousand times!
A validation plan is a living strategy, so you’ll need to adapt it as your system evolves—read my latest column to find out how.
I provide a roadmap for escaping the 'validation treadmill': what to automate and more importantly what to ignore. At no extra cost, I share a risk-based methodology lovingly ripped off from common sense and years of battling bureaucracy. Intrigued? Read the article!
In a stretch for some, we discuss the possibility of actually ENJOYING the process. Please note the word ENJOYING!
#CSV #Validation #QualityMatters #LabAutomation
https://lnkd.in/example-link
<end of post>
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