PROS Readability Risk Assessment®
Your team thinks the documentation is fine. So did everyone who got a warning letter.
Unclear SOPs and procedures never announce themselves. They surface later as a finding, an incident, or a failed audit. The PROS Readability Risk Assessment shows you where your documentation puts you at risk, while you can still fix it.
The PROS Readability Risk Assessment shows you where your documentation puts you at risk, while you can still fix it.
20 minutes. You’ll leave knowing exactly where you’re exposed, before it turns into a finding.
DE-RISKING DOCUMENTATION FOR REGULATED INDUSTRIES FOR 35+ YEARS
SOP-114 · BATCH RECORD
RISK FOUND
SOP-114 · BATCH RECORD REVIEW
RISK FOUND
TRUSTED ACROSS REGULATED INDUSTRIES
IT’S NOT IF. IT’S WHEN.
The risk already moved into your documents.
Enforcement caught up. In pharma and biotech, a third-party review of 470 FDA warning letters issued in 2025 found 469 cited a documentation or records failure. In energy, utilities, and manufacturing, the same gap shows up as an OSHA citation or a safety incident the moment a procedure is misread.The consequence is real, and it lands on the organization that could not show its work. This isn’t a future risk. It’s already sitting in a document somewhere in your organization, waiting to be read by someone whose job is to find it
469
of 470
FDA warning letters in 2025 cited a documentation or records failure
35
+ yrs
De-risking documentation for regulated teams
1
Unclear sentence is all it takes to turn a procedure into a finding
Source: QBench, Inside 470 FDA Warning Letters From 2025, based on the FDA.gov Warning Letters database (2025).
THE UNCOMFORTABLE TRUTH
You don’t have a writing problem. You have a missing standard.
Most teams treat documentation as a writing problem, so they buy a writing course. We’ve taught that course for 35 years, so we can say it plainly: training alone doesn’t hold without a standard underneath it. Without one, every document review becomes one person’s opinion. Here is how the risk builds.
01 · SYMPTOM
The documents are still unclear.
Reviewers keep sending drafts back. Cycles slow, and someone senior spends their nights rewriting other people's work.
02 · ROOT CAUSE
There is no standard.
Nobody in the building can say what a finished, compliant document looks like. Quality is whoever reviewed it last.
03 · HOW IT SPREADS
Every team inherits it.
Quality, regulatory, and engineering all review to a different bar and communication noise compounds across departments.
04 · WHAT IT COSTS
It surfaces as a finding.
A warning letter, a safety incident, a failed audit. The bill always arrives, and it arrives with your name on it.
Every week without a standard is another week every team inherits the same risk. The cost doesn’t pause while you decide.
Book Your Risk Discovery Call →
THE ASSESSMENT
An x-ray of your documentation, before the surgery.
The PROS Readability Risk Assessment® is a structured audit of how your organization writes, reviews, and uses its documents. We look at the system, not just the sentences. You see exactly where you are exposed and what to fix first.
What you walk away with
A robust report, our PROS Roadmap™ and a clear picture of where your documentation puts you at risk. You’ll learn what it is costing you in time and rework, and have a prioritized path to fix it.
Baseline it now, and we can measure the improvement later.
The organizations that skip this step find out what it was worth during their next audit, not before it.
OUR PROCESS
Analyze your documentation for the patterns that create risk
Examine reviewer feedback: is it actionable and does it improve document quality?
Interview writers, reviewers, and users to uncover the issues they see
Review your processes, standards, templates, and checklists for risks existing within the gaps
Quantify time and money lost to poor processes, slow review times, and subpar tools
SEE IT FIRST
See a real assessment before you talk to anyone.
Download an example assessment from your industry and see how one review can surface risk across an entire organization. Three blinded assessments, each from a team that thought their documentation was fine.
Every one of these teams assumed their documentation was fine, right up until we looked. See what a real review would find in yours.
PHARMA & BIOTECH
$145,598
/yr
An F1000 eyecare company recovered $145,598 a year and 45% of its lost output. Reviews came back 63% faster.
ENERGY & UTILITIES
$718,692
/yr
An F1000 utilities company defused a $718,692-a-year SOP problem and lifted field confidence to 90%.
MANUFACTURING
$500K+
/yr
An F1000 manufacturer cut writing and review costs by hundreds of thousands a year. Review time fell 33%.
WHO YOU’RE WORKING WITH
You don’t pass an audit because your team took a class.
You pass because the work meets a standard, every time, no matter who wrote it. That is what we build. For more than 35 years, across pharma, energy, and manufacturing, Hurley Write has found the root cause behind documentation risk and built the standard that closes it. Practitioners with doctorates in the discipline, not a course off a shelf.
We find the root cause. Most of what puts you at risk has nothing to do with grammar. We name it before we prescribe.
We build the system. One shared standard for what good looks like, so quality stops being whoever reviewed it last.
It holds when we leave. Your writers keep the standard and your reviewers keep it honest, long after the engagement ends.
Every one of these teams assumed their documentation was fine, right up until we looked. See what a real review would find in yours.
FIND YOUR RISK
See where your documentation is exposed.
The risk is already in your documents, whether or not anyone’s looked yet. Start with a short call and we’ll show you exactly where you’re exposed and what to fix first, before an auditor, a regulator, or an incident does it for you. If you share a document, everything is covered by an NDA.
Show Me a Sample Assessment →Not ready to talk? See a real diagnostic first.
