Author | Lightnews

Nate Roman

@nateroman.bsky.social

3 followers 3 following 120 posts

With a focus on content strategy, social media management, and promoting validation and temperature mapping solutions. I am active in sharing industry insights, educational content, and engaging with professionals on SoMe platforms.

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Nate Roman @nateroman.bsky.social · 2d

What if I told you there was a solution that could completely eliminate the need to repeat freezer studies and cut your reporting time in half?

What would it mean for you and your team if validation was no longer a source of anxiety, but a streamlined, predictable process?

Nate Roman @nateroman.bsky.social · 3d

Imagine a system where you could place loggers in a -80°C freezer, run the study for its full duration, and know with 100% certainty that the batteries would last and the data would be secure.

How would that change your approach to qualification and your team's efficiency?

Nate Roman @nateroman.bsky.social · 5d

Use of risk tools (like FMEA) is encouraged.

WHO, ISPE, and major validation vendors recommend risk assessments to find critical zones - i.e., spots likely to be hot/cold or most sensitive for product quality.

Nate Roman @nateroman.bsky.social · 6d

Good practice starts with a structured mapping strategy.

Protocols require that equipment design, airflow, heat sources, and product loads all inform sensor locations.

Nate Roman @nateroman.bsky.social · 7d

“Poor sensor placement strategy” is a frequent root cause.

Industry guidance and mapping audits routinely cite unclear or unjustified placement as a leading deficiency - often due to lack of...

→ airflow analysis
→ risk assessment, or
→ connection to product vulnerability

Nate Roman @nateroman.bsky.social · 8d

Stop Repeating Freezer Studies: Introducing TrackSense™ Frigo UX Sky

✅️ Live data
✅️ Fewer delays
✅️ More production time

Read More:

Stop Repeating Freezer Studies with TrackSense™ Frigo UX Sky

Frigo UX Sky gives you a real-time view into your freezer studies, so you can act early and prevent failures to complete qualifications on time.

www.ellab.com

Nate Roman @nateroman.bsky.social · 9d

Sensor placement is both technical and strategic.

Placement must be intentional and risk-based, not random.

As poor placement can undermine both study outcomes and compliance.

Nate Roman @nateroman.bsky.social · 10d

Systems that are "Not Direct Impact" only require commissioning under Good Engineering Practice (GEP).

- ISPE Baseline® Guide (2nd Edition)

Nate Roman @nateroman.bsky.social · 10d

Direct Impact Systems are those that directly affect Critical Quality Attributes (CQAs) or the quality of critical utility systems — and they must be commissioned and qualified.

Nate Roman @nateroman.bsky.social · 10d

In CQV, system classification is a process that determines a system's potential impact on product quality.

Systems are categorized as Direct Impact or Not Direct Impact.

Nate Roman @nateroman.bsky.social · 12d

Sensor placement isn’t guesswork — it’s validation by design.

Nate Roman @nateroman.bsky.social · 13d

Smart placement saves time, prevents rework, and earns trust during audits.

Nate Roman @nateroman.bsky.social · 14d

TrackSense® Frigo UX Sky – Freezer Data Loggers | Ellab

Discover TrackSense® Frigo UX Sky freezer data loggers for reliable fridge & freezer validation. Real-time visibility, –90 °C to +140 °C coverage, and ValSuite® integration ensure efficient…

www.ellab.com

Nate Roman @nateroman.bsky.social · 15d

Good mapping starts with intention — not just instrumentation. 🤔

Nate Roman @nateroman.bsky.social · 16d

Every temperature probe tells a story — make sure yours has a reason to be where it is.

Nate Roman @nateroman.bsky.social · 17d

The overall purpose of validation and qualification is to provide structured assurance that systems & processes are...

→ designed
→ maintained
→ and operated

...in a state of control and are suitable for their intended purpose.

Nate Roman @nateroman.bsky.social · Sep 19

Adaptability separates managers from leaders.

Digital transformation, data-driven compliance, new tech—those who bridge tradition with innovation shape the future of CQV.

Nate Roman @nateroman.bsky.social · Sep 19

The Strategic Business Leader role is about balance:

🔹 Vision with execution
🔹 Expertise with adaptability
🔹 Commercial drive with human leadership

That balance is what grows organizations—even in a down economy.

Nate Roman @nateroman.bsky.social · Sep 18

Commercial Savvy means more than selling.

It’s about creating long-term value deals and guiding clients toward solutions that outlast the contract.

True leaders build relationships, not transactions.

Nate Roman @nateroman.bsky.social · Sep 18

Industry Expertise = credibility.

If you don’t understand CQV, compliance, and the regulatory landscape, no strategy will stick.
Vision only works when it’s anchored in reality.

Nate Roman @nateroman.bsky.social · Sep 17

✅ Strategic Vision isn’t a buzzword.

It’s the discipline of aligning new opportunities with what your company can actually deliver.
Leaders who master this don’t just see the future—they build it.

#CQV #Leadership

Nate Roman @nateroman.bsky.social · Sep 17

Growth in pharma consulting isn’t about bigger budgets.
It’s about sharper strategy.

In a down economy, leaders win by protecting compliance, cutting waste, and building alliances that outlast downturns.

#Validation #CQV #Leadership

Nate Roman @nateroman.bsky.social · Sep 16

Entrepreneurial leaders in EPC & validation don’t wait for the rebound.
They create it.

✅ Flexible engagement models
✅ Digital-first CQV
✅ Partnerships that scale

That’s how you grow when markets contract.

#LifeSciences #CQV

Nate Roman @nateroman.bsky.social · Sep 16

In pharma & biotech, compliance is non-negotiable.

That’s why smart leaders position CQV not as a cost—but as risk protection, continuity, and speed-to-market.

The entrepreneurial mindset sees downturns as proof points, not setbacks.

Nate Roman @nateroman.bsky.social · Sep 15

Every project is more than execution.
It’s a platform for growth.

Entrepreneurial leaders connect CQV results to faster audits, smoother launches, and safer products.

That’s how you move from service provider → strategic partner.

#Pharma #Validation