by PathWise | Feb 10, 2021 | FDA, Uncategorized, White Papers
Inadequate Procedures: A Challenge to the Medical Industry As global populations increase and people are living longer, more strain is being placed on the life science industry. Complex business models have evolved, and new technologies are implemented to support...
by PathWise | Feb 3, 2021 | Uncategorized
FDA 483 Observations from 2020 Every year, PathWise compiles information on the top FDA 483 observations from the previous year’s inspection observations. 2020 was a year like no other, with the Coronavirus halting FDA inspections for a time. The results for the...
by pathwise123 | Jan 20, 2021 | Uncategorized
Which Probability Distribution Should You Use? There are many probability distributions that are useful in describing common phenomena in the manufacturing and service industries. Also called probability mass functions (PMFs), they can be used to answer questions...
by pathwise123 | Jan 15, 2021 | Uncategorized
ALCOA: A Data Integrity Standard For many years, data integrity has been of particular concern to both industry and global regulatory authorities. Data integrity requirements have increased, especially with the advent of new technologies and their need for rapid...
by pathwise123 | Jan 3, 2021 | Uncategorized
SEVEN Key Components for your Complaint Handling System The Product Complaint Handing system defined in 21 CFR 820.198 (Complaint Files) requires procedures and processes for receiving, evaluating, investigating, remediating, documenting and reporting, record keeping...
by PathWise | Nov 18, 2020 | Uncategorized
The Importance of Good Laboratory Practice (GLP) Protocol There are a few key words that one should have at the forefront of their mind as they conduct non-clinical GLP studies. These words are quality and reproducibility. The regulations clearly state each study...
