Temperature Mapping Got You Stressed? | Let me help | Follow for Temp Mapping & Validation Insights ✨

What if I told you temperature mapping isn’t really about temperature?

It’s about protecting lives, ensuring compliance, and preserving trust.

While temperature is the data you’re measuring, the true goal lies beyond the numbers. It’s about safeguarding product integrity, ensuring patient safety, and upholding your organization’s reputation. Temperature mapping isn’t just a technical requirement—it’s a critical step in delivering life-saving products to those who need them most.

For over 24 years, I’ve helped life sciences companies elevate their validation processes—not just meeting global regulations but exceeding them. As a recognized thought leader in temperature mapping and equipment qualification, I’ve shaped industry standards, contributed to ISPE guidelines, and trained professionals worldwide.

Some highlights of my work include:
✅ Helping 100+ pharmaceutical and biotech companies achieve FDA & EU GMP compliance.
✅ Optimizing validation strategies to reduce timelines by up to 30% without compromising quality.
✅ Authoring industry-leading content and best practice guides.
✅ Educating and empowering professionals through training, articles, and thought leadership in validation, calibration, and compliance.

📈 With over 18K LinkedIn followers, I’m also an ISPE Good Practice Guide co-author and the author of Six Steps to Effective Temperature Mapping. My thought leadership has driven business wins, secured global speaking engagements, and positioned me as a trusted expert in the field.

So why isn’t temperature mapping about temperature? Because it’s about something far greater—the lives you’re protecting, the products you’re preserving, and the trust you’re building every step of the way.

Let’s connect to explore how we can take your validation process beyond compliance to deliver real impact.

🔍 #CQV | #Validation | #Qualification | #ISPE | #Entrepreneurship | #ContentCreation | #TemperatureMapping | #QualityAssurance | #LifeSciences | #ColdChain | #GMPCompliance

Nathan Roman 📈

Had a great week collaborating with my colleagues from Denmark, Switzerland and UK/Ireland! 

→ Strategy. 
→ Campaign planning. 
→ And... just a little bit of fun. 

When we align on what truly matters, share insights with openness, and stay committed to creating value, we build more than results - we build traction. Whether in business or life, clarity and connection turn vision into momentum. ☺️ 

Excited about the opportunities we are mapping for Ellab and the journey ahead!

#Ellabers #Strategy #Growth #Validation #Innovation

I help life science leaders reduce risk and increase confidence through proven CQV, calibration & asset management strategies - turning compliance headaches into operational wins with Ellab’s end-to-end solutions.

Quality and business performance are inseparable.

When a company faces an FDA inspection or a major audit,
it’s not just a test of systems -

it’s a test of trust.

And the people watching most closely aren’t always regulators or investors.
→ They’re your customers.
→ They’re your employees.

Recently, a vaccine manufacturer confronted serious FDA findings -
right in the middle of a pending acquisition.

Yet operations continued.
Customers stayed loyal.
Employees stayed focused.

Why?

Because leadership didn’t hide.
They stepped into the spotlight - owned the issue, communicated clearly, and moved fast to correct it.

That’s the real story:

Regulatory resilience isn’t built during a crisis.
It’s built every day before one.

It’s built every time your team:
✅ Updates documentation before an audit notice arrives.
✅ Treats CAPA as a process for learning, not blame.
✅ Communicates openly - inside and outside the company - when something needs fixing.

These daily habits build trust.
They protect not just your license to operate -
but your license to lead.

Because when confidence is shaken,
it’s not the process that saves you - it’s the people who believe in it.

I help life-sciences teams gain confidence and control in validation, calibration, and temperature mapping through clear, practical guidance that removes confusion, reduces risk, and strengthens quality outcomes.

Calibration & Validation — What's the Difference?

If you're working in — or breaking into — biotech, pharma, or lab operations, you'll hear these terms constantly. And they're not interchangeable.

✔️ Validation shows that a process or system consistently performs as intended.
✔️ Calibration ensures an instrument is accurate compared to a reference standard.

I wrote an article that breaks both concepts down in simple terms — when they're needed, how they're performed, and why they matter for quality and patient safety.

👉 Read the full article here: https://lnkd.in/eM6TiGeB

The table below gives you a side-by-side comparison to make the distinctions even clearer.

P.S. Does this structure make the distinctions clearer for your team or clients?

Nathan Roman: Validation & Calibration

My biggest lesson from the last 20+ years in validation?
We can’t keep using yesterday’s methods for tomorrow’s problems.

(Especially when the industry is becoming more digital by the day.)

Next month, I’m co-hosting an ISPE webinar with Michelle Vuolo and Tatiana Illgen called: 

"Unlocking Innovation: Embracing Validation 4.0 for a Digital Pharma Future"
 
And if your team is feeling the pressure to move faster while staying compliant - this one matters.

Because Validation 4.0 isn’t an upgrade. It’s a paradigm shift.

It moves us from:
❌ Fixed, static validation runs
❌ Paper-heavy documentation
❌ One-time “prove it once” thinking
❌ Slow evidence generation that delays release

To a model built for a digital pharma future:
✅ Real-time, data-driven evidence
✅ Scalable digital systems
✅ Continuous learning and improvement
✅ Stronger, leaner verification of control

And the best part?
It doesn’t replace fundamentals - it builds on them:
• Quality by Design
• Quality Risk Management
• Knowledge Management

We’ll walk through how this shift helps teams avoid bottlenecks, accelerate timelines, and maintain verifiable control in an increasingly digital environment.

What you’ll learn:
✔️ How Validation 4.0 removes traditional validation bottlenecks
✔️ How digital, real-time evidence speeds product release
✔️ 1–2 case studies showing this approach in practice
✔️ Why modern data systems are essential for GxP integrity
✔️ How to prepare your operations for this shift today

If your site, team, or projects still feel “stuck” in older validation ways - this is a good place to start fresh.

Register here: https://lnkd.in/eX9ZfSDf

👉 If you want to see more posts on CQV, temperature mapping, and validation strategy, be sure to follow me, Nathan Roman 📈.

#Validation40 #CQV #LifeSciences #AI #DataIntegrity #GxPCompliance #DigitalTransformation #ISPE

Every day there are professionals out there looking for clear, practical guidance.

❌ Not theory
❌ Not vague advice

But steps they can use on the job — today.

And here’s what often gets overlooked:

I don’t just talk about temperature mapping.

I talk about how work really moves across a GMP lifecycle — from concept → design → commissioning → qualification → monitoring → continuous compliance.

I speak across the entire compliance lifecycle:

→ Regulatory standards
→ Industry guides
→ Risk management
→ Process design
→ Validation strategy
→ CQV
→ Commissioning
→ IQ/OQ/PQ
→ Monitoring
→ Data integrity
→ Documentation

These are the areas teams wrestle with every day — and they deserve straightforward support, not complicated answers.

This new 9-step ULT freezer mapping guide is just one example of that commitment.

It’s for the people who want to work correctly, confidently, and without guesswork.

If you want the guide, be sure to click here: https://lnkd.in/drxZUuSs

🎯 Streamline your Next Validation or Qualification Project

Every successful ULT freezer qualification starts with a clear, structured process - one that saves time, reduces risk, and ensures compliance every step of the way.

At Ellab, we combine global expertise with local support to help life science companies navigate qualification and validation efficiently and confidently.

Our 9-Step Guide breaks down the full process from preparation to final reporting, helping you:
✅ Strengthen data integrity and audit readiness
✅ Reduce downtime and complexity
✅ Gain consistency across sites and teams

📘 Download the full guide and see how to optimize your validation and qualification projects here: https://lnkd.in/drxZUuSs

If you have doubts, ask the author Nathan Roman 📈 directly in the comments!

A 9-Step Guide to Temperature Mapping an Ultra-Low Freezer

Last night, I had the privilege of leading a remote session with professionals at Ellab Academy Singapore.

Participants didn't just attend - they got the chance to really take a look into temperature mapping and CQV fundamentals:

→ From foundational strategy → to flawless execution.

A big thank you to Nerissa Low, Nevil Ng, Roger Sanson and Bhavesh Panchal for the invitation and for including me in such a meaningful, global program. 🙏

It's truly inspiring to connect with professionals who share the same crucial mission:

- Improving quality
- Ensuring compliance
- Elevating patient safety

Even from across the globe, the curiosity, engagement, and unwavering commitment to doing things the right way was encouraging. That’s the power of Ellab Academy!

In this session, we focused on connecting principles with practice and building true confidence in data and systems.

We covered key topics that directly impact data integrity and successful validation:

✅ Determining sensor locations & numbers
✅ The role of mapping inside the CQV lifecycle
✅ Common mistakes that compromise data integrity
✅ How documentation turns data into defensible proof

P.S. 👇 If your team is planning an equipment qualification or a temperature mapping study and needs expert guidance on:

→ Protocol design
→ Sensor strategy
→ Execution support
→ Compliance documentation

Let’s talk!

👉 Send me a DM or book a short call - I’d be happy to help you plan your next successful study.

#Ellab #TemperatureMapping #CQV #Validation #Compliance #EllabAcademy #LifeSciences #Pharma

📸 Here’s a glimpse from the session in Singapore. If you missed this one, stay tuned for future Ellab Academy events around the world!

Happy Thanksgiving, LinkedIn Fam 🦃

Just waiting for the other family to show up.

In our house, we still have the adult table…
…and the “kids” table.

Except the kids are now 16, 17, and 18.
Time really does move fast.

Are you sitting at the adult table or the “kids” table this year? 😂 

Grateful today.
Grateful always.

Enjoy the day, however you’re celebrating.

No alternative text description for this image

Most companies don’t need another validation vendor.

They need a better outcome from the work they already pay for.

Here’s the question I always ask:

“If nothing changed with your current vendor, what would the next 12 months look like?”

If the answer is delays, rework, or qualification anxiety…

You don’t have a vendor problem. You have a system problem.

My solution:

The Vendor Upgrade Framework:
	1.	Identify friction
	2.	Map risk
	3.	Replace weak processes
	4.	Standardize documentation
	5.	Deliver predictable outcomes

This isn’t about switching vendors.
It’s about switching to predictability.

Want your validation done right the first time? I’m the easiest upgrade you’ll make this year—and the one that sets you up for a winning year ahead. 

Let’s work together! ✌️

Stop treating Commissioning and Qualification as separate hurdles.

Embrace an integrated C&Q process from day one.

A single, risk-based verification plan saves time, reduces cost, and accelerates your speed-to-market. It's that simple.

Legacy thinking keeps them apart. Modern practice brings them together. For detailed guidance, refer to the ISPE Baseline® Guide: Volume 5 – Commissioning and Qualification (Second Edition).

#CQV #Validation #Commissioning #ISPE #Ellab #Lean #Efficiency #ProjectManagement

They say you can't succeed alone, and these past couple of years proved it. 

These guys are the definition of 'all in.' 

They embody the energy, the strategy, and the heart brought to every single challenge we tackled.

I’ve been lucky to have partners who support me and who bring that unmatched 'Rod Tidwell' energy—pure loyalty and heart.

Help me help you... celebrate these guys! 🙌

Thank you for helping me accomplish so much. Here’s to your continued success—you guys deserve it all.

🎥: Gordie Tamayo and Joe Wilde

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You don’t find the right team. 
You build it.

(And that changes everything about how you lead.)

Everyone talks about finding the “right people.”

The truth?

Leadership shapes the team into being right.

In honor of our vets this week, I’d like to share a story Mark O'Donnell once wrote on leadership and team performance.

https://lnkd.in/e_GxeGui

He said something that stuck with me: “There are no bad teams, only bad leaders.”

In the story, he shared how a struggling Navy SEAL team turned things around the moment their leader changed.

Same people. Different outcome.

It wasn’t talent that made the difference — it was leadership.

Mark also shared an example close to home: my own journey leading validation teams over the years.

He talked about how belief, humility, and teamwork built a high-performing group that’s stayed together for years and outperformed by 20% margin.

It’s wasn’t luck.
It’s not credentials.
It’s leadership — the kind that inspires, enables, and stays connected.

When leaders take full responsibility for outcomes, something powerful happens:

• Trust grows
• Performance rises
• Potential turns into proof

There are no bad teams — only leaders who haven’t found their rhythm yet.

Read more here: https://lnkd.in/e_GxeGui

If you’re leading a CQV, validation, or compliance project and need a partner who brings both leadership and technical depth — I can help.

Send me a DM or book a quick call to learn how I can help.

Who owns your state of control - and do they know it? 💡

Part 5 of our 'Temperature Matters' series reveals how to build and sustain a culture of thermal compliance. Empower your teams with targeted training and reinforce ownership across operations, QA, and facilities.

📖 Read now: Temperature Matters | Building a Culture of Control

Welcome to the final edition of Temperature Matters, closing our five-part series on the foundations of thermal compliance. Across the past four editi

Open article: Part 5: Building a Culture of Control by Nathan Roman 📈 • 9 min read

What if the risks you're managing during qualification are already too late? 

Part 4 of our 'Temperature Matters' series explores integrating QRM into every phase of mapping and qualification. Discover how ICH Q9 principles and performance data drive lean, robust strategies. 😁👍 

📖 Read now: Temperature Matters | The Role of Risk Management

Welcome to the latest edition of Temperature Matters, part four of our five-part series on the foundations of thermal compliance. Last time, we explor

Open article: Part 4: The Role of Risk Management by Nathan Roman 📈 • 9 min read

Most CQV delays aren’t technical failures.
They’re scheduling failures.

I’ve seen $2M+ projects sit idle because no one planned for CQV upfront.

Here’s what gets missed…

→ Document generation and review cycles
→ Execution windows and resource availability
→ Final report approvals

The 3 mistakes that kill timelines:

1. Late involvement

▪️Validation gets looped in after equipment is ordered.
▪️Now you’re retrofitting requirements instead of building them in.

2. No clear definition of “done”

▪️When is equipment qualified? When is the area validated? When can production start?
▪️Without defined acceptance criteria, you’ll debate this at the finish line.

3. Incomplete turnover packages

▪️Engineering hands off equipment without:
→ Calibration records
→ As-built drawings
→ Vendor documentation
▪️Now validation is chasing paperwork instead of executing.

The fix: CQV isn’t a phase at the end.

It’s a workstream that runs parallel to your entire project.

→ Budget for it. 
→ Schedule for it. 
→ Staff for it.

If you’re making these mistakes right now, you’ve got two choices:

1️⃣ Keep hoping the next project goes better (it won’t).
2️⃣ Or bring in someone who’s done this 1,000+ times.

I help pharma and biotech companies:

→ Build CQV into project plans from day one
→ Define turnover criteria that eliminate finish-line chaos
→ Execute qualification strategies that pass audits without drama

The companies I work with don’t scramble at the end.

They don’t delay production starts.

They don’t get audit findings on qualification gaps.

DM me “PROJECT” and I’ll show you exactly where the landmines are in your timeline. 👍🏻

Quality isn’t supposed to clean up everyone else’s problems.

Yet that’s exactly what happens.

If QA is discovering the issues, the process already failed.

Quality shouldn’t be the first to find the problem.

They should be the last.

Good systems make QA a confirmation step — not a rescue operation.

When QA is constantly firefighting, you don’t have a quality problem.

You have a process problem.

P.S. Does QA at your site spend more time preventing or reacting?

Lifecycle Labs

One stop for complete environmental monitoring (EM) services for GMP clean rooms.
• All EM samples incubated in accordance with US Pharmacopeia guidelines
▪ Capacity of incubation: up to 1,500 EM plates
• Summary reports available within 24hours of incubation completion.

Offering:
▪ Routine and dynamic EM sampling, as well as support during EM PQ execution
▪ Growth promotion test for culture media
▪ Selection of representative colonies on EM plates
▪ Microbial identification using third party labs
▪ Maintenance of microbial libraries for in-house isolates
▪ Routine trending of EM data
▪ Quarterly reports for EM programs
• Incubation of Biological indicators in validated incubators, up to 2,000 biological indicators
▪ Incubation of Media Fill Containers

Managing Partner

Lifecycle Compliance

Providing Commissioning, Qualification and Validation Services. Key skills and characteristics include expertise in the following areas:

•	Manufacturing Facilities and Utilities
•	Manufacturing equipment 
•	Packaging and labeling equipment 
•	Laboratory equipment
•	Computer systems
•	Building Automation systems 
•	Warehouses
•	CIP Cycle Development
•	SIP Cycle Development
•	Validation Master Plan
•	Commissioning and Qualification Plan
•	Project Management

IPS-Integrated Project Services, LLC

Projects: Permanent Intravenous Admixture Unit (P-IVAU) Pharmacy, Center for Cellular Engineering East Terrace Modular Facility and National Cancer Institute TIL Modular Facility at National Institute of Health Bethesda MD. 

Reviewed and commented on facility specifications and submittals, in preparation for final approvals by client. 
Generated and executed commissioning checklists and reports for all facility utility systems, including HVAC, Building Automation System, Electrical distribution, Emergency Power,  Chilled water, Medical Gases, Telecommunications, Security system etc. using Good Documentation Practices (GDPs).
Developed and Performed integrated system testing. This involved testing the interaction and functionality of multiple systems within a facility to ensure that they are operating correctly and in accordance with the design specification. 
Developed and executed validation protocols including HVAC Cleanrooms, Environmental Monitoring System, Medical Gases, Airflow Visualization ensuring compliance with cGMPs and other regulatory requirements. 
Investigated and resolved commissioning and validation protocol exceptions / discrepancies.
Led CQV meetings and provide update to stakeholders on weekly basis.

CQV Project Lead 

DPS Group Global

Walter Reed National Military Medical Center, Silver Spring MD

Commissioned Building Automation System (BAS); ensured controls are properly wired and communicating with the BAS, that alarms are generated and trended as required, and that the BAS is operating as per the design specification
Developed a detailed plan for testing and validating the performance of the air handling units (AHU’s), Exhaust Fan Units (EFU), Chilled Water System (CHW), Hot Water System (HWS) as well as executed test plan using good documentation practice. 
Walked down P&ID identifying all of the components of the AHU system, including ductwork, exhaust fans, dampers, and any other relevant components. 
Developed and Performed integrated system testing. This involves testing the interaction and functionality of multiple systems within a facility to ensure that they are operating correctly and in accordance with the design specification.

CQV Engineer

Azzur Group

Novo Nordisk, West Lebanon NH

Led and executed Room Qualification on two new manufacturing suites. Tests included: Air Changes, Particulate Count, HEPA Leak, Differential Pressures, and Interlocks testing.
Performed thermal mapping of temperature-controlled chambers, warehouses, and SIP (Sterilization-in-Place) on bioreactors.
Executed CIP (Clean-in-Place) recipes on upstream and downstream manufacturing equipment without any unplanned intervention.

Validation Engineer

Atlantic Technical & Validation Services, LLC

Glenmark Pharmaceutical, Monroe NC

Developed and executed an IQ/OQ/PQ protocol for a Nitrogen distribution system and Compressed Air distribution system.
Executed IQ/OQ protocols and cleaning/riboflavin studies for a Bin Washer.
Executed IQ/OQ/PQ protocols for packaging line equipment including Tablet Counter, Filling Machine, Desiccator, Labeler etc...

University of New Hampshire

Undergraduate research was performed at University of New Hampshire which was funded by UNH McNair and National Science Foundation. Our Research was focused on surface chemistry and materials chemistry to develop innovative catalysts for sustainable energy applications in real world. A process of particular interest was solar fuel generation by carbon dioxide reduction on surface catalysts. As a part of undergraduate researcher my focus was to investigate effect of morphology on titanium dioxide photocatalysis. 

-Competitively selected for funding from McNair scholar program and National Science Foundation 
-Synthesized nano-particles catalyst with focus on carbon dioxide reduction using photocatalysis
-Characterized material using BET, XRD, SEM, and TEM for analysis
-Performed Dye-degradation test using different dye-molecules such as Methal-blue to see reactivity 
-Analyzed inconsistencies and made adjustments to synthesis procedure; tested efficiency of material in its application
-Analyzed data using MS Excel
-Participated and presented research at University of California Berkeley McNair Symposium 2014 and University of Maryland 2015
-Asked to serve as a member of Advisory Committee; provide feedback on research being proposed in order to obtain funding

Undergraduate Researcher

Hannaford Bros. Co.

-Coordinated with 80 other associates to facilitate best customer service
-Provided customers with fast and friendly check out

Cashier

Ram Subedi is a seasoned professional with hands-on experience in commissioning, qualification, and validation of GMP Facilities, Utilities and Equipment in the pharmaceutical and biotech industry . He has a proven track record of successfully leading projects from start to finish, ensuring that all requirements meet or exceed industry standards and regulatory requirements. Extremely passionate about excellence and execution and always strive to approach every task with a right-first-time mentality. 

Born in a refugee camp in Nepal, Ram faced numerous challenges in his early life, but that never dampened his determination to succeed. He immigrated to the United States in 2009 with a strong desire to better himself and his community. He obtained a degree in Chemical Engineering and immediately began working in the pharmaceutical industry. He is a dedicated and passionate individual who never forgets his humble beginnings and always strives to improve not just for himself but for his community as well. He is known for his ability to appreciate the little things in life and always brings a positive attitude to the workplace.

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