Nonconforming products happen but managing them before they spin out of control is important. With QualiPro you can...
Jayme Brace
FDA and Dietary Supplements
The $40 billion dietary supplement industry is still growing making it a market you may want to take advantage of, but...
CAPA Management with QualiPro
Having a good CAPA management system is a key element in making sure your CAPA process is successful. QualiPro has the...
Eliminate your CAPA Headache with 6 Easy Steps
CAPAs are often the most dreaded task to complete and the words “open a CAPA” can bring audible sighs and groans, but...
FDA Compliance Without the Stress
Ensuring you have a robust Quality Management System (QMS) is the first step in maintaining compliance with both FDA...
Does Your CBD Product Measure Up?
It seems like everyone and their dog are using products containing CBD, but are they safe, effective, and in...
The Future in Digital Healthcare is Now
With the continued advances of Artificial Intelligence and Machine Learning (AI/ML), we are at the forefront of a new...
Are Your Reprocessed Single Use Devices, EU MDR Ready?
With less than a year until the end of the EU MDR transition period, it is pertinent to ensure that all devices to be...
Is your Post-Market Surveillance System Proactive?
Post-Market Surveillance (PMS) is required for medical devices. There are two types of post-market surveillance –...
Are You Finding True Root Causes?
A root cause is a factor which caused a nonconformance and should be permanently eliminated through process...
Clinical Lactation Studies: Considerations for Study Design
On May 8, 2019, FDA released draft guidance, Clinical Lactation Studies: Considerations for Study Design, building...
Modification after Initial Review and Transparency and Real-World Performance Monitoring
The next installment in our blog series on Artificial Intelligence/ Machine Learning (AI/ ML) based Software as a...
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