What NASA’s New Horizons has in Common with Regulatory Writing

What NASA’s New Horizons has in Common with Regulatory Writing

Today, NASA’s New Horizons spacecraft will pass by Pluto in the outer solar system after a journey of more than 7.8 million miles (12.5 million kilometers). That is, if everything goes well. After a 6-year journey and a cost of $728 million dollars, mission managers are hoping to avoid a mission ending error caused by a lack of quality control. Surely the engineers and scientists at NASA have checked and double-checked every line of code in order to preserve this costly, historic mission?

Not so fast. Consider the September 1999 loss of the NASA Mars Climate Orbiter, launched in 1998. The orbiter missed its target altitude insertion by 80 to 90 km and burned up in the Martian atmosphere. Findings of the failure review board indicated that the navigation error leading to the loss of the spacecraft resulted from some commands being sent in English units instead of being converted to metric. After a journey of 10 months and a cost of $193.1 million, a simple English to metric units conversion ended up being this program’s downfall. With a $728 million dollar, 6-year mission on the line, one would hope that NASA has invested significantly more funding in dedicated quality control this time around. We won’t have to wait long to find out.

While a lack of dedicated quality control in regulatory documentation preparation may not result in such costly failures, they may still cause significant problems with government regulatory bodies. Consider the time and cost investment into your product. How much is that worth to you? To your shareholders? To the patient population you are hoping to serve?

Errors in regulatory writing, whether from typographical and spelling, missing proper reference citations, incorrect verb tense, and inconsistent formatting, are ever present and often escape even the most vigilant of writers. Often times, errors occur in our writing because we do not take the time to look at every letter and every word. Consider the following statement:

What I if told you

you read the

first line wrong?

How many of you read the first line incorrectly?

What about this next statement?

S1M1L4RLY, Y0UR M1ND 15 R34D1NG 7H15 4U70M471C4LLY W17H0U7 3V3N 7H1NK1NG 4B0U7 17.

From a quality standpoint, both examples would need to be corrected. Yet, most individuals will have no trouble reading either sentence correctly. We are able to correctly read these two examples because our brains subconsciously filled in any gaps in the letters based on subsequent context. Simply put, without the conscious act of proofing every single letter and word, our brains can make us believe that a sentence, paragraph, or document contains no errors. Uncorrected, errors in writing may remain for years, or even a century or more as in the 2014 New York Times correction of an error in a 161-year-old article (The January 20, 1853 misspelling of 12 Years a Slave memoir author Solomon Northup (spelled Northrup in the original article).

Whether you want to prevent a multi-million dollar space probe failure, physical harm to a patient, or loss of investor confidence, having a dedicated quality review of your writing should be a top priority for any company. In the end…

Let’s eat grandma.

Let’s eat, grandma.

Commas save lives…

How to improve your document quality

I’ve provided some resources to help you improve the quality of your crucial regulatory documents.

Are you questioning the quality of your documents?

At Synchrogenix, a Certara company, quality is our priority. We have developed a quality control checklist that is document specific and used throughout the life of a document. Our rigorous quality control processes include data checking; formatting; editing for spelling, grammar, and clarity; and ensuring publishing readiness. In addition, our industry experts provide objective content review. Want to learn more? Read this case study about how we helped a sponsor to achieve document quality to support regulatory filings.

Michael Blaze

About the Author

Michael Blaze, PhD is a Senior Regulatory Writer at Synchrogenix Information Strategies, Inc., in Cary, NC where he writes regulatory medical documents for clients in the device and pharmaceutical development arenas.