Gravity and Quality Assurance
As we’ve now moved on from another cold winter month, I was captivated recently thinking about Quality Assurance and our collective responsibilities. All kinds of things come to mind; Deviations,...
Are You Maximizing Your Return on Data Investment?
Generating process data is expensive: Costs include materials, process time and the focus of highly-compensated subject matter experts. Unfortunately, many organizations don’t get their money’s worth...
Are You Ready for AIQ?
Do you find yourself in one of the following situations? + Your equipment has broken down due to frequent usage or wear and thus requires repair. You realize that once repaired, any equipment will...
Looking to the Cloud for your Business
computer susteIt’s a Friday afternoon. Quarter’s end. Your V.P. of Regulatory Affairs calls your office bellowing something about not being able to process the latest submission data- can’t access...
Clinical Research Solutions
If You Didn't Write It Down...
Since the day I entered the industry the mantra of "If you didn’t write it down, it didn’t happen" was repeatedly drilled into my daily mode of operation. The margins of my test sheets were filled...
Clinical Research Solutions
CAPA and the Importance of Effective Technical Writing
My apologies to you in the technical writing profession out there, but there are not too many topics that are as bland and unappealing as technical writing. Personally, I'd rather step on a sharp...
Using Propagation of Error to Determine Validation Acceptance Criteria for In-Process Measurements
Many times in validation I am confronted with the problem of how to set acceptance criteria for critical process measurements. This is particularly true of in process measurements made during...
Sneak Preview: What Will the Quality Metrics Initiative Look Like?
I had lunch in a restaurant the other day. During my meal, I noticed that there weren't many other customers. I didn't give it much thought until I walked out and read the restaurant's hygiene grade...
Is social media the next monitoring emphasis for the OIG?
In June 2014, the FDA issued two draft social media guidance documents that may not clearly answer all of the questions that the drug and device industries have about how to use social media to...
Risk Assessments Mitigate Risk for Bigger and Smaller Companies Alike
Earlier this year, the Officer of Inspector General (OIG) put smaller life sciences companies on notice that they should put in place a risk assessment process as part of their corporate compliance...
Clinical Research Solutions
Quality System Professionals: Learn how to Speak “Executive-ese”
It is amazing to me that more C-Level Executives do not perceive their Quality Systems as a powerful vehicle to reduce costs, improve productivity, and benefit their bottom line. Rather than embrace...
Cleaning Disaster or True Worst Case?
How robust are your cleaning validation measures? Could your storage procedures withstand the impacts of a fire within your facility, or would such a disaster set back your production time...
Improving Computerized System Quality Through Design Verification
Unverified Design – An Example For those of us who travel routinely, one of the most sought-after treasures in the typical airport terminal is an electrical outlet. With our dependency on mobile...
Computer System Validation: Resolutions for the New Year
How are you doing with those New Years’ resolutions? Whether or not you’re a resolution maker (or breaker), you can use this time of year to take stock of where things stand, including your validated...
Impact of Wavelength Accuracy and Precision on Spectrophotometric Measurements
A while back I was involved in a Quality Assurance project reviewing calibration specifications for analytical instrumentation. The client had implemented a new requirement that all calibrated...
Clinical Research Solutions
U.S. Attorneys Send Strong Message that a Company’s Response to a Compliance Issue is Key Element of an Effective Compliance Program
A common theme among the government enforcers speaking at last week’s Pharmaceutical Compliance Congress (PCC) was the importance of putting in place an effective corporate compliance program to...